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    Clinical Trial Results:
    A Phase IIa Randomised, Double Blind, Multi-centre Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults with Type 2 Diabetes

    Summary
    EudraCT number
    		 2020-000931-35
    Trial protocol
    		 DE  
    Global end of trial date
    09 Jun 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    22 Feb 2024
    First version publication date
    16 Jun 2022
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D6470C00005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04556760
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    Södertälje, Södertälje, Sweden, 15185
    Public contact
    Global Clinical Head, AstraZeneca Clinical Study Information Center, +1 87724094 79, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Head, AstraZeneca Clinical Study Information Center, +1 87724094 79, information.center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Aug 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the pharmacodynamic effect of AZD9567 on glucose homeostasis compared to prednisolone.
    Protection of trial subjects
    This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Council for Harmonisation Good Clinical Practices (ICH-GCP), applicable regulatory requirements, and the AstraZeneca policy on Bioethics.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Nov 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 46
    Worldwide total number of subjects
    46
    EEA total number of subjects
    46
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    16
    From 65 to 84 years
    30
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This cross-over study was conducted in Germany between 26 November 2020 and 09 June 2021.

    Pre-assignment
    Screening details
    		 The Screening period was of 14 days which may be extended up to a maximum of 28 days. Informed consent was obtained from all patients before performing any study tests or procedures. All the study assessments were performed as per the schedule of assessment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1
    Arm description
    		 Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD956
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received Prednisolone 40 mg/day for 3 consecutive days (Day 1 to 3) of each treatment period

    Investigational medicinal product name
    AZD9567
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received AZD9567 72 mg/day for 3 consecutive days (Day 1 to 3) of each treatment period.

    Arm title
    		 Cohort 2
    Arm description
    		 Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD9567
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received AZD9567 40 mg/day for 3 consecutive days (Day 1 to 3) of each treatment period

    Investigational medicinal product name
    Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received Prednisolone 20 mg/day for 3 consecutive days (Day 1 to 3) of each treatment period

    Arm title
    		 Cohort 3
    Arm description
    		 Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received Prednisolone 5 mg/day for 3 consecutive days (Day 1 to 3) of each treatment period

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received Placebo for 3 consecutive days (Day 1 to 3) of each treatment period

    Number of subjects in period 1
    		Cohort 1 Cohort 2 Cohort 3
    Started
    28
    9
    9
    Completed
    27
    8
    9
    Not completed
    1
    1
    0
         Consent withdrawn by subject
    1
    -
    -
         Positive SARS-CoV-2 for patient’s daughter
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD956

    Reporting group title
    Cohort 2
    Reporting group description
    		 Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567

    Reporting group title
    Cohort 3
    Reporting group description
    		 Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo

    Reporting group values
    		 Cohort 1 Cohort 2 Cohort 3 Total
    Number of subjects
    		 28 9 9 46
    Age categorical
    Units: Subjects
        18 - 44 (years)
    		 1 0 0 1
        45 - 64 (years)
    		 8 4 3 15
        65 - 75 (years)
    		 19 5 6 30
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 67.3 ( 6.41 ) 64.4 ( 9.32 ) 66.6 ( 5.36 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 4 3 1 8
        Male
    		 24 6 8 38
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 1 0 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 1 1 0 2
        White
    		 26 8 9 43
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD956

    Reporting group title
    Cohort 2
    Reporting group description
    		 Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567

    Reporting group title
    Cohort 3
    Reporting group description
    		 Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo

    Subject analysis set title
    Cohort 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD956

    Subject analysis set title
    Cohort 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567

    Subject analysis set title
    Cohort 3
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo

    Primary: Change from baseline in glucose area under the plasma concentration versus time curve from zero to 4 hours post-dose AUC(0-4)

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    End point title
    		 Change from baseline in glucose area under the plasma concentration versus time curve from zero to 4 hours post-dose AUC(0-4)
    End point description
    The change from baseline in glucose AUC(0-4) was analysed to determine the Pharmacodynamic (PD) effect of AZD9567 compared to Prednisolone following a standardised Mixed meal tolerance test (MMTT). The Subject Analysis set was added to report statistical analysis and this is the only option available in order to accommodate reporting of statistical data for cross over cohorts. Here, arbitrary value 9999.9999 represent not applicable. Full Analysis Set (FAS) consisted of all randomised patients who received at least 1 dose of study treatment.
    End point type
    Primary
    End point timeframe
    On Days -1 (baseline), and Days 4 (Treatment period 1 and 2)
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    27
    8
    9
    27
    8
    9
    Units: minute*millimole/liter (min*mmol/L)
    least squares mean (standard error)
        AZD9567
    -190.0296 ( 63.8805 )
    -182.7172 ( 149.8600 )
    9999.9999 ( 9999.9999 )
    -190.0296 ( 63.8805 )
    -182.7172 ( 149.8600 )
    9999.9999 ( 9999.9999 )
        Prednisolone
    -57.0768 ( 63.8762 )
    -40.6842 ( 141.7154 )
    -184.9677 ( 88.9807 )
    -57.0768 ( 63.8762 )
    -40.6842 ( 141.7154 )
    -184.9677 ( 88.9807 )
        Placebo
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    -311.8506 ( 88.5443 )
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    -311.8506 ( 88.5443 )
    Statistical analysis title
    		 AZD9567 72mg vs Prednisolone 40mg
    Statistical analysis description
    Pairwise Comparison with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)
    Comparison groups
    Cohort 1 v Cohort 1
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.036
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -132.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -256.5
         upper limit
    		 -9.39
    Notes
    [1] - 27 patients were evaluated in this analysis
    Statistical analysis title
    		 Placebo vs Prednisolone 5mg
    Statistical analysis description
    Pairwise Comparison with Prednisolone (Placebo vs Prednisolone 5mg)
    Comparison groups
    Cohort 3 v Cohort 3
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.03
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -126.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -236.04
         upper limit
    		 -17.72
    Notes
    [2] - 9 patients were evaluated in this analysis
    Statistical analysis title
    		 AZD9567 40mg vs Prednisolone 20mg
    Statistical analysis description
    Pairwise Comparison with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)
    Comparison groups
    Cohort 2 v Cohort 2
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.432
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -142.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -554.87
         upper limit
    		 270.8
    Notes
    [3] - 8 patients were evaluated in this analysis

    Secondary: Mean daily glucose at 48 – 72 hours treatment as determined from multiple measures via the Continuous Glucose Monitoring (CGM) system

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    End point title
    		 Mean daily glucose at 48 – 72 hours treatment as determined from multiple measures via the Continuous Glucose Monitoring (CGM) system
    End point description
    The mean daily glucose was analysed to determine the effect of AZD9567 on CGM compared to prednisolone. The Subject Analysis set was added to report statistical analysis and this is the only option available in order to accommodate reporting of statistical data for cross over cohorts. Here, arbitrary value 9999.9999 represent not applicable. Full Analysis Set (FAS) consisted of all randomised patients who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    On Days 2 and 3 (Treatment period 1 and 2)
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    27
    8
    9
    27
    8
    9
    Units: millimole/liter (mmol/L)
    least squares mean (standard error)
        AZD9567
    8.5730 ( 0.3114 )
    7.7870 ( 0.2517 )
    9999.9999 ( 9999.9999 )
    8.5730 ( 0.3114 )
    7.7870 ( 0.2517 )
    9999.9999 ( 9999.9999 )
        Prednisolone (n= 26,8,9)
    10.0797 ( 0.3150 )
    8.8969 ( 0.2494 )
    7.4238 ( 0.2889 )
    10.0797 ( 0.3150 )
    8.8969 ( 0.2494 )
    7.4238 ( 0.2889 )
        Placebo
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    7.2638 ( 0.2888 )
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    7.2638 ( 0.2888 )
    Statistical analysis title
    		 Placebo vs Prednisolone 5mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)
    Comparison groups
    Cohort 3 v Cohort 3
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0.547
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.69
         upper limit
    		 0.37
    Notes
    [4] - 9 patients were evaluated in this analysis
    Statistical analysis title
    		 AZD9567 40mg vs Prednisolone 20mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)
    Comparison groups
    Cohort 2 v Cohort 2
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [5]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.72
         upper limit
    		 -0.49
    Notes
    [5] - 8 patients were evaluated in this analysis
    Statistical analysis title
    		 AZD9567 72mg vs Prednisolone 40mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)
    Comparison groups
    Cohort 1 v Cohort 1
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.08
         upper limit
    		 -0.93
    Notes
    [6] - 27 patients were evaluated in this analysis

    Secondary: Rise in mean daily glucose over 24-hour periods from start of IMP dosing (0 – 24 hours, 24 – 48 hours, 48 – 72 hours)

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    End point title
    		 Rise in mean daily glucose over 24-hour periods from start of IMP dosing (0 – 24 hours, 24 – 48 hours, 48 – 72 hours)
    End point description
    The mean glucose level in mmol/L was analysed to determine the effect of AZD9567 on CGM compared to prednisolone. For the calculation of the rise in mean glucose levels, the baseline was the average of the values from -24 hours to first dosing on Day 1 of each period. The Subject Analysis set was added to report statistical analysis and this is the only option available in order to accommodate reporting of statistical data for cross over cohorts. Here, arbitrary value 9999.9999 represent not applicable.
    End point type
    Secondary
    End point timeframe
    Baseline and up to 72 hours (Treatment period 1 and 2)
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    27
    8
    9
    27
    8
    9
    Units: mmol/L
    least squares mean (standard error)
        AZD9567 (00 to 24 hours [h])
    1.2071 ( 0.2869 )
    0.4070 ( 0.2509 )
    9999.9999 ( 9999.9999 )
    1.2071 ( 0.2869 )
    0.4070 ( 0.2509 )
    9999.9999 ( 9999.9999 )
        Prednisolone (00 to 24 h) (n= 26,8,9)
    2.7086 ( 0.2938 )
    1.2545 ( 0.2460 )
    0.3123 ( 0.1549 )
    2.7086 ( 0.2938 )
    1.2545 ( 0.2460 )
    0.3123 ( 0.1549 )
        Placebo (00 to 24 h)
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    -0.0477 ( 0.1547 )
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    -0.0477 ( 0.1547 )
        AZD9567 (24 to 48 h)
    0.8011 ( 0.2978 )
    0.5428 ( 0.2483 )
    9999.9999 ( 9999.9999 )
    0.8011 ( 0.2978 )
    0.5428 ( 0.2483 )
    9999.9999 ( 9999.9999 )
        Prednisolone (24 to 48 h) (n= 26,8,9)
    2.6653 ( 0.3044 )
    1.3206 ( 0.2448 )
    -0.2415 ( 0.2898 )
    2.6653 ( 0.3044 )
    1.3206 ( 0.2448 )
    -0.2415 ( 0.2898 )
        Placebo (24 to 48 h)
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    -0.3260 ( 0.2894 )
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    -0.3260 ( 0.2894 )
        AZD9567 (48 to 72 h)
    0.8529 ( 0.3210 )
    0.0744 ( 0.2714 )
    9999.9999 ( 9999.9999 )
    0.8529 ( 0.3210 )
    0.0744 ( 0.2714 )
    9999.9999 ( 9999.9999 )
        Prednisolone (48 to 72 h) (n= 26,8,9)
    2.4527 ( 0.3274 )
    1.2174 ( 0.2664 )
    -0.2202 ( 0.2229 )
    2.4527 ( 0.3274 )
    1.2174 ( 0.2664 )
    -0.2202 ( 0.2229 )
        Placebo (48 to 72 h)
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    -0.3500 ( 0.2224 )
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    -0.3500 ( 0.2224 )
    Statistical analysis title
    		 AZD9567 72mg vs Prednisolone 40mg [00 to 24 h]
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg [00 to 24 h])
    Comparison groups
    Cohort 1 v Cohort 1
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.22
         upper limit
    		 -0.77
    Notes
    [7] - 27 patients were evaluated in this analysis
    Statistical analysis title
    		 AZD9567 72mg vs Prednisolone 40mg [24 to 48 h]
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg [24 to 48 h])
    Comparison groups
    Cohort 1 v Cohort 1
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.56
         upper limit
    		 -1.16
    Notes
    [8] - 27 patients were evaluated in this analysis
    Statistical analysis title
    		 AZD9567 72mg vs Prednisolone 40mg [48 to 72 h]
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg [48 to 72 h])
    Comparison groups
    Cohort 1 v Cohort 1
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 -0.89
    Notes
    [9] - 27 patients were evaluated in this analysis
    Statistical analysis title
    		 AZD9567 40mg vs Prednisolone 20mg [00 to 24 h]
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg [00 to 24 h])
    Comparison groups
    Cohort 2 v Cohort 2
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    P-value
    		 = 0.013
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.44
         upper limit
    		 -0.24
    Notes
    [10] - 8 patients were evaluated in this analysis
    Statistical analysis title
    		 AZD9567 40mg vs Prednisolone 20mg [24 to 48 h]
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg [24 to 48 h])
    Comparison groups
    Cohort 2 v Cohort 2
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    P-value
    		 = 0.061
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 0.04
    Notes
    [11] - 8 patients were evaluated in this analysis
    Statistical analysis title
    		 AZD9567 40mg vs Prednisolone 20mg [48 to 72 h]
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg [48 to 72 h])
    Comparison groups
    Cohort 2 v Cohort 2
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 [12]
    P-value
    		 = 0.003
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.76
         upper limit
    		 -0.52
    Notes
    [12] - 8 patients were evaluated in this analysis
    Statistical analysis title
    		 Placebo vs Prednisolone 5 mg [00 to 24 h]
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5 mg [00 to 24 h])
    Comparison groups
    Cohort 3 v Cohort 3
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 other [13]
    P-value
    		 = 0.125
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.83
         upper limit
    		 0.11
    Notes
    [13] - 9 patients were evaluated in this analysis
    Statistical analysis title
    		 Placebo vs Prednisolone 5 mg [24 to 48 h]
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5 mg [24 to 48 h])
    Comparison groups
    Cohort 3 v Cohort 3
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 other [14]
    P-value
    		 = 0.84
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.97
         upper limit
    		 0.8
    Notes
    [14] - 9 patients were evaluated in this analysis
    Statistical analysis title
    		 Placebo vs Prednisolone 5 mg [48 to 72 h]
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5 mg [48 to 72 h])
    Comparison groups
    Cohort 3 v Cohort 3
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 other [15]
    P-value
    		 = 0.571
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.64
         upper limit
    		 0.38
    Notes
    [15] - 9 patients were evaluated in this analysis

    Secondary: Change from baseline in fasting glucose

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    End point title
    		 Change from baseline in fasting glucose
    End point description
    Pharmacodynamic effects (fasting glucose) of AZD9567 following a MMTT were evaluated as compared to prednisolone. The Subject Analysis set was added to report statistical analysis and this is the only option available in order to accommodate reporting of statistical data for cross over cohorts. Here, arbitrary value 9999.9999 represent not applicable. FAS consisted of all randomised patients who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    27
    8
    9
    27
    8
    9
    Units: mmol/L
    least squares mean (standard error)
        AZD9567
    -1.14 ( 0.17 )
    -0.95 ( 0.36 )
    9999.9999 ( 9999.9999 )
    -1.14 ( 0.17 )
    -0.95 ( 0.36 )
    9999.9999 ( 9999.9999 )
        Prednisolone
    -1.06 ( 0.17 )
    -0.91 ( 0.35 )
    -1.15 ( 0.20 )
    -1.06 ( 0.17 )
    -0.91 ( 0.35 )
    -1.15 ( 0.20 )
        Placebo
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    -1.15 ( 0.20 )
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    -1.15 ( 0.20 )
    Statistical analysis title
    		 AZD9567 72mg vs Prednisolone 40mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)
    Comparison groups
    Cohort 1 v Cohort 1
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other [16]
    P-value
    		 = 0.753
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.55
         upper limit
    		 0.4
    Notes
    [16] - 27 patients were evaluated in this analysis
    Statistical analysis title
    		 Placebo vs Prednisolone 5mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)
    Comparison groups
    Cohort 3 v Cohort 3
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 [17]
    P-value
    		 = 0.985
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.37
         upper limit
    		 0.37
    Notes
    [17] - 9 patients were evaluated in this analysis
    Statistical analysis title
    		 AZD9567 40mg vs Prednisolone 20mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)
    Comparison groups
    Cohort 2 v Cohort 2
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 [18]
    P-value
    		 = 0.802
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 0.37
    Notes
    [18] - 8 patients were evaluated in this analysis

    Secondary: Change from baseline AUC(0-4) on hormones related to glucose homeostasis (Insulin)

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    End point title
    		 Change from baseline AUC(0-4) on hormones related to glucose homeostasis (Insulin)
    End point description
    Effects of AZD9567 on insulin AUC(0-4) were assessed following MMTT compared to prednisolone. Here, arbitrary value 9999.9999 represent not applicable. FAS consisted of all randomised patients who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    27
    8
    9
    27
    8
    9
    Units: minute*picomole/liter (min*pmole/L)
    least squares mean (standard error)
        AZD9567 (n= 21,8,9)
    15319.3857 ( 4165.9135 )
    13413.1929 ( 4791.9873 )
    9999.9999 ( 9999.9999 )
    15319.3857 ( 4165.9135 )
    13413.1929 ( 4791.9873 )
    9999.9999 ( 9999.9999 )
        Prednisolone (n= 23,7,9)
    -5179.3659 ( 3989.2683 )
    10091.7869 ( 5461.2631 )
    4915.4115 ( 7049.5460 )
    -5179.3659 ( 3989.2683 )
    10091.7869 ( 5461.2631 )
    4915.4115 ( 7049.5460 )
        Placebo
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    2216.5532 ( 7049.0432 )
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    2216.5532 ( 7049.0432 )
    Statistical analysis title
    		 AZD9567 72mg vs Prednisolone 40mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)
    Comparison groups
    Cohort 1 v Cohort 1
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 [19]
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    20498.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10819.2
         upper limit
    		 30178.2
    Notes
    [19] - 27 patients were evaluated in this analysis
    Statistical analysis title
    		 Placebo vs Prednisolone 5mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)
    Comparison groups
    Cohort 3 v Cohort 3
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 other [20]
    P-value
    		 = 0.521
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2698.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14849
         upper limit
    		 9451.3
    Notes
    [20] - 9 patients were evaluated in this analysis
    Statistical analysis title
    		 AZD9567 40mg vs Prednisolone 20mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)
    Comparison groups
    Cohort 2 v Cohort 2
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other [21]
    P-value
    		 = 0.659
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3321.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12975.8
         upper limit
    		 19618.6
    Notes
    [21] - 8 patients were evaluated in this analysis

    Secondary: Change from baseline AUC(0-4) on hormones related to glucose homeostasis (Glucagon)

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    End point title
    		 Change from baseline AUC(0-4) on hormones related to glucose homeostasis (Glucagon)
    End point description
    Effects of AZD9567 on glucagon AUC(0-4) were assessed following MMTT in comparison to prednisolone. Here, arbitrary value 9999.9999 represent not applicable. FAS consisted of all randomised patients who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    27
    8
    9
    27
    8
    9
    Units: min*pmol/L
    least squares mean (standard error)
        AZD9567
    -36.9846 ( 216.5777 )
    552.0634 ( 213.9300 )
    9999.9999 ( 9999.9999 )
    -36.9846 ( 216.5777 )
    552.0634 ( 213.9300 )
    9999.9999 ( 9999.9999 )
        Prednisolone
    965.6018 ( 216.6054 )
    511.0798 ( 213.5970 )
    259.9835 ( 298.9801 )
    965.6018 ( 216.6054 )
    511.0798 ( 213.5970 )
    259.9835 ( 298.9801 )
        Placebo
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    361.3971 ( 348.5104 )
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    361.3971 ( 348.5104 )
    Statistical analysis title
    		 AZD9567 72mg vs Prednisolone 40mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)
    Comparison groups
    Cohort 1 v Cohort 1
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other [22]
    P-value
    		 = 0.003
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1002.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1620.21
         upper limit
    		 -384.95
    Notes
    [22] - 27 patients were evaluated in this analysis
    Statistical analysis title
    		 Placebo vs Prednisolone 5mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)
    Comparison groups
    Cohort 3 v Cohort 3
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 other [23]
    P-value
    		 = 0.754
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    101.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -628.8
         upper limit
    		 831.63
    Notes
    [23] - 9 patients were evaluated in this analysis
    Statistical analysis title
    		 AZD9567 40mg vs Prednisolone 20mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)
    Comparison groups
    Cohort 2 v Cohort 2
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 [24]
    P-value
    		 = 0.865
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    40.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -526.69
         upper limit
    		 608.66
    Notes
    [24] - 8 patients were evaluated in this analysis

    Secondary: Change from baseline AUC(0-4) on hormones related to glucose homeostasis (Glucagon-like peptide-1 [GLP-1])

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    End point title
    		 Change from baseline AUC(0-4) on hormones related to glucose homeostasis (Glucagon-like peptide-1 [GLP-1])
    End point description
    Effects of AZD9567 on GLP-1 AUC(0-4) were assessed following MMTT in comparison to prednisolone. The Subject Analysis set was added to report statistical analysis and this is the only option available in order to accommodate reporting of statistical data for cross over cohorts. Here, arbitrary value 9999.9999 represent not applicable. FAS consisted of all randomised patients who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    27
    8
    9
    27
    8
    9
    Units: min*pmol/L
    least squares mean (standard error)
        AZD9567
    615.9803 ( 328.8418 )
    322.5690 ( 454.2028 )
    9999.9999 ( 9999.9999 )
    615.9803 ( 328.8418 )
    322.5690 ( 454.2028 )
    9999.9999 ( 9999.9999 )
        Prednisolone
    1841.8853 ( 328.8877 )
    789.5492 ( 450.2548 )
    575.6726 ( 318.1088 )
    1841.8853 ( 328.8877 )
    789.5492 ( 450.2548 )
    575.6726 ( 318.1088 )
        Placebo
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    200.3565 ( 317.6326 )
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    200.3565 ( 317.6326 )
    Statistical analysis title
    		 AZD9567 72mg vs Prednisolone 40mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)
    Comparison groups
    Cohort 1 v Cohort 1
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other [25]
    P-value
    		 = 0.004
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1225.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2007.22
         upper limit
    		 -444.58
    Notes
    [25] - 27 patients were evaluated in this analysis
    Statistical analysis title
    		 Placebo vs Prednisolone 5mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)
    Comparison groups
    Cohort 3 v Cohort 3
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 other [26]
    P-value
    		 = 0.404
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -375.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1433.62
         upper limit
    		 682.99
    Notes
    [26] - 9 patients were evaluated in this analysis
    Statistical analysis title
    		 AZD9567 40mg vs Prednisolone 20mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)
    Comparison groups
    Cohort 2 v Cohort 2
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other [27]
    P-value
    		 = 0.313
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -466.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1521.5
         upper limit
    		 587.54
    Notes
    [27] - 8 patients were evaluated in this analysis

    Secondary: Change from baseline AUC(0-4) on hormones related to glucose homeostasis (Glucose-dependent insulin releasing polypeptide [GIP])

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    End point title
    		 Change from baseline AUC(0-4) on hormones related to glucose homeostasis (Glucose-dependent insulin releasing polypeptide [GIP])
    End point description
    Effects of AZD9567 on GIP AUC(0-4) were assessed following MMTT in comparison to prednisolone. The Subject Analysis set was added to report statistical analysis and this is the only option available in order to accommodate reporting of statistical data for cross over cohorts. Here, arbitrary value 9999.9999 represent not applicable. FAS consisted of all randomised patients who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    27
    8
    9
    27
    8
    9
    Units: min*pmol/L
    least squares mean (standard error)
        AZD9567
    3658.9885 ( 584.5079 )
    3842.9307 ( 1303.1553 )
    9999.9999 ( 9999.9999 )
    3658.9885 ( 584.5079 )
    3842.9307 ( 1303.1553 )
    9999.9999 ( 9999.9999 )
        Prednisolone (n= 26,8,9)
    3293.3563 ( 596.7472 )
    3654.6947 ( 1289.5516 )
    3271.5164 ( 823.9967 )
    3293.3563 ( 596.7472 )
    3654.6947 ( 1289.5516 )
    3271.5164 ( 823.9967 )
        Placebo
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    2210.0670 ( 827.7335 )
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    2210.0670 ( 827.7335 )
    Statistical analysis title
    		 AZD9567 72mg vs Prednisolone 40mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)
    Comparison groups
    Cohort 1 v Cohort 1
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other [28]
    P-value
    		 = 0.608
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    365.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1097.79
         upper limit
    		 1829.06
    Notes
    [28] - 27 patients were evaluated in this analysis
    Statistical analysis title
    		 Placebo vs Prednisolone 5mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)
    Comparison groups
    Cohort 3 v Cohort 3
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 other [29]
    P-value
    		 = 0.381
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1061.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3588.22
         upper limit
    		 1465.32
    Notes
    [29] - 9 patients were evaluated in this analysis
    Statistical analysis title
    		 AZD9567 40mg vs Prednisolone 20mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)
    Comparison groups
    Cohort 2 v Cohort 2
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other [30]
    P-value
    		 = 0.897
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    188.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3214.33
         upper limit
    		 3590.8
    Notes
    [30] - 8 patients were evaluated in this analysis

    Secondary: Change from baseline in AUC(0-4) on C-peptide

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    End point title
    		 Change from baseline in AUC(0-4) on C-peptide
    End point description
    Effects of AZD9567 on C-peptide AUC(0-4) were assessed through a MMTT in comparison to prednisolone. The Subject Analysis set was added to report statistical analysis and this is the only option available in order to accommodate reporting of statistical data for cross over cohorts. Here, arbitrary value 9999.9999 represent not applicable. FAS consisted of all randomised patients who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    27
    8
    9
    27
    8
    9
    Units: minute*nanomole/L (min*nmol/L)
    least squares mean (standard error)
        AZD9567
    85.3305 ( 13.4279 )
    82.1134 ( 22.9858 )
    9999.9999 ( 9999.9999 )
    85.3305 ( 13.4279 )
    82.1134 ( 22.9858 )
    9999.9999 ( 9999.9999 )
        Prednisolone
    24.9094 ( 13.4282 )
    55.6606 ( 22.6155 )
    24.7245 ( 22.2183 )
    24.9094 ( 13.4282 )
    55.6606 ( 22.6155 )
    24.7245 ( 22.2183 )
        Placebo
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    0.7002 ( 22.0424 )
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    0.7002 ( 22.0424 )
    Statistical analysis title
    		 AZD9567 72mg vs Prednisolone 40mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)
    Comparison groups
    Cohort 1 v Cohort 1
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other [31]
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    60.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 29.49
         upper limit
    		 91.35
    Notes
    [31] - 27 patients were evaluated in this analysis
    Statistical analysis title
    		 Placebo vs Prednisolone 5mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)
    Comparison groups
    Cohort 3 v Cohort 3
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 other [32]
    P-value
    		 = 0.282
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -24.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -74.07
         upper limit
    		 26.02
    Notes
    [32] - 9 patients were evaluated in this analysis
    Statistical analysis title
    		 AZD9567 40mg vs Prednisolone 20mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)
    Comparison groups
    Cohort 2 v Cohort 2
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other [33]
    P-value
    		 = 0.432
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    26.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -44.94
         upper limit
    		 97.84
    Notes
    [33] - 8 patients were evaluated in this analysis

    Secondary: Change from baseline in ratio of insulin to glucose level between 10 and 0 minutes (ΔI10/ΔG10)

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    End point title
    		 Change from baseline in ratio of insulin to glucose level between 10 and 0 minutes (ΔI10/ΔG10)
    End point description
    Effects of AZD9567 on ΔI10/ΔG10 of beta cell function from the MMTT compared to Prednisolone was evaluated. The Subject Analysis set was added to report statistical analysis and this is the only option available in order to accommodate reporting of statistical data for cross over cohorts. Here, arbitrary value 9999.9999 represent not applicable. FAS consisted of all randomised patients who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    27
    8
    9
    27
    8
    9
    Units: Ratio
    least squares mean (standard error)
        AZD9567 (n= 16,8,9)
    -0.5249 ( 0.6632 )
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    -0.5249 ( 0.6632 )
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
        Prednisolone (n= 18,8,5)
    0.0774 ( 0.6674 )
    9999.9999 ( 9999.9999 )
    -0.8153 ( 0.8305 )
    0.0774 ( 0.6674 )
    9999.9999 ( 9999.9999 )
    -0.8153 ( 0.8305 )
        Placebo (n=27,8,7)
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    -0.3532 ( 0.6893 )
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    -0.3532 ( 0.6893 )
    Statistical analysis title
    		 Placebo vs Prednisolone 5mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)
    Comparison groups
    Cohort 3 v Cohort 3
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 other [34]
    P-value
    		 = 0.682
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.09
         upper limit
    		 3.01
    Notes
    [34] - 9 patients were evaluated in this analysis
    Statistical analysis title
    		 AZD9567 72mg vs Prednisolone 40mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)
    Comparison groups
    Cohort 1 v Cohort 1
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 [35]
    P-value
    		 = 0.531
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.54
         upper limit
    		 1.34
    Notes
    [35] - 27 patients were evaluated in this analysis

    Secondary: Change from baseline in ratio of insulin to glucose level between 30 and 0 minutes [ΔI30/ΔG30])

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    End point title
    		 Change from baseline in ratio of insulin to glucose level between 30 and 0 minutes [ΔI30/ΔG30])
    End point description
    Effects of AZD9567 on ΔI30/ΔG30 of beta cell function from the MMTT compared to Prednisolone was evaluated. The Subject Analysis set was added to report statistical analysis and this is the only option available in order to accommodate reporting of statistical data for cross over cohorts. Here, arbitrary value 9999.9999 represent not applicable. FAS consisted of all randomised patients who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    27
    8
    9
    27
    8
    9
    Units: Ratio
    least squares mean (standard error)
        AZD9567 (n= 25,8,9)
    0.1203 ( 0.0726 )
    0.1824 ( 0.0773 )
    9999.9999 ( 9999.9999 )
    0.1203 ( 0.0726 )
    0.1824 ( 0.0773 )
    9999.9999 ( 9999.9999 )
        Prednisolone (n= 24,6,8)
    0.0530 ( 0.0755 )
    0.0943 ( 0.1264 )
    -0.1047 ( 0.0665 )
    0.0530 ( 0.0755 )
    0.0943 ( 0.1264 )
    -0.1047 ( 0.0665 )
        Placebo
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    0.0209 ( 0.0599 )
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    0.0209 ( 0.0599 )
    Statistical analysis title
    		 AZD9567 72mg vs Prednisolone 40mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)
    Comparison groups
    Cohort 1 v Cohort 1
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other [36]
    P-value
    		 = 0.526
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.28
    Notes
    [36] - 27 patients were evaluated in this analysis
    Statistical analysis title
    		 Placebo vs Prednisolone 5mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)
    Comparison groups
    Cohort 3 v Cohort 3
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 other [37]
    P-value
    		 = 0.166
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 0.31
    Notes
    [37] - 9 patients were evaluated in this analysis
    Statistical analysis title
    		 AZD9567 40mg vs Prednisolone 20mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)
    Comparison groups
    Cohort 2 v Cohort 2
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other [38]
    P-value
    		 = 0.569
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.26
         upper limit
    		 0.44
    Notes
    [38] - 8 patients were evaluated in this analysis

    Secondary: Change from baseline in ratio of C-peptide to glucose level between 10 and 0 minutes (ΔC10/ΔG10)

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    End point title
    		 Change from baseline in ratio of C-peptide to glucose level between 10 and 0 minutes (ΔC10/ΔG10)
    End point description
    Effects of AZD9567 on ΔC10/ΔG10 of beta cell function from the MMTT compared to Prednisolone was evaluated. The Subject Analysis set was added to report statistical analysis and this is the only option available in order to accommodate reporting of statistical data for cross over cohorts. Here, arbitrary value 9999.9999 represent not applicable. FAS consisted of all randomised patients who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    27
    8
    9
    27
    8
    9
    Units: Ratio
    least squares mean (standard error)
        AZD9567 (n= 17,6,9)
    -0.0004 ( 0.0095 )
    0.0059 ( 0.0041 )
    9999.9999 ( 9999.9999 )
    -0.0004 ( 0.0095 )
    0.0059 ( 0.0041 )
    9999.9999 ( 9999.9999 )
        Prednisolone (n= 20,4,6)
    -0.0103 ( 0.0092 )
    0.0026 ( 0.0047 )
    -0.0033 ( 0.0064 )
    -0.0103 ( 0.0092 )
    0.0026 ( 0.0047 )
    -0.0033 ( 0.0064 )
        Placebo (n= 27,8,7)
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    -0.0024 ( 0.0057 )
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    -0.0024 ( 0.0057 )
    Statistical analysis title
    		 AZD9567 72mg vs Prednisolone 40mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)
    Comparison groups
    Cohort 1 v Cohort 1
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 [39]
    P-value
    		 = 0.226
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.0072
         upper limit
    		 0.0271
    Notes
    [39] - 27 patients were evaluated in this analysis
    Statistical analysis title
    		 Placebo vs Prednisolone 5mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)
    Comparison groups
    Cohort 3 v Cohort 3
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 other [40]
    P-value
    		 = 0.917
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.0009
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.0189
         upper limit
    		 0.0207
    Notes
    [40] - 9 patients were evaluated in this analysis
    Statistical analysis title
    		 AZD9567 40mg vs Prednisolone 20mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)
    Comparison groups
    Cohort 2 v Cohort 2
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other [41]
    P-value
    		 = 0.619
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.0033
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.0128
         upper limit
    		 0.0195
    Notes
    [41] - 8 patients were evaluated in this analysis

    Secondary: Change from baseline in ratio of C-peptide to glucose level between 30 and 0 minutes (ΔC30/ΔG30)

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    End point title
    		 Change from baseline in ratio of C-peptide to glucose level between 30 and 0 minutes (ΔC30/ΔG30)
    End point description
    Effects of AZD9567 on ΔC30/ΔG30 of beta cell function from the MMTT compared to Prednisolone was evaluated. The Subject Analysis set was added to report statistical analysis and this is the only option available in order to accommodate reporting of statistical data for cross over cohorts. Here, arbitrary value 9999.9999 represent not applicable. FAS consisted of all randomised patients who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    27
    8
    9
    27
    8
    9
    Units: Ratio
    least squares mean (standard error)
        AZD9567
    0.0012 ( 0.0005 )
    0.0007 ( 0.0005 )
    9999.9999 ( 9999.9999 )
    0.0012 ( 0.0005 )
    0.0007 ( 0.0005 )
    9999.9999 ( 9999.9999 )
        Prednisolone
    0.0005 ( 0.0005 )
    0.0004 ( 0.0005 )
    -0.0010 ( 0.0005 )
    0.0005 ( 0.0005 )
    0.0004 ( 0.0005 )
    -0.0010 ( 0.0005 )
        Placebo
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    0.0002 ( 0.0005 )
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    0.0002 ( 0.0005 )
    Statistical analysis title
    		 AZD9567 72mg vs Prednisolone 40mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)
    Comparison groups
    Cohort 1 v Cohort 1
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 [42]
    P-value
    		 = 0.357
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.0007
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.0008
         upper limit
    		 0.0022
    Notes
    [42] - 27 patients were evaluated in this analysis
    Statistical analysis title
    		 Placebo vs Prednisolone 5mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)
    Comparison groups
    Cohort 3 v Cohort 3
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 other [43]
    P-value
    		 = 0.096
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.0012
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.0002
         upper limit
    		 0.0026
    Notes
    [43] - 9 patients were evaluated in this analysis
    Statistical analysis title
    		 AZD9567 40mg vs Prednisolone 20mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)
    Comparison groups
    Cohort 2 v Cohort 2
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other [44]
    P-value
    		 = 0.676
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.0003
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.0012
         upper limit
    		 0.0017
    Notes
    [44] - 8 patients were evaluated in this analysis

    Secondary: Change from baseline in 24-hour urinary potassium concentration

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    End point title
    		 Change from baseline in 24-hour urinary potassium concentration
    End point description
    The concentration of potassium in urine was measured over 24 hours to determine the effect of AZD9567 on urinary potassium (U-K) excretion compared to prednisolone. The Subject Analysis set was added to report statistical analysis and this is the only option available in order to accommodate reporting of statistical data for cross over cohorts. Here, arbitrary value 9999.9999 represent not applicable. FAS consisted of all randomised patients who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    27
    8
    9
    27
    8
    9
    Units: mmol/day
    least squares mean (standard error)
        AZD9567
    -2.92 ( 3.27 )
    -6.05 ( 4.30 )
    9999.9999 ( 9999.9999 )
    -2.92 ( 3.27 )
    -6.05 ( 4.30 )
    9999.9999 ( 9999.9999 )
        Prednisolone
    -1.19 ( 3.27 )
    4.92 ( 4.29 )
    -2.49 ( 9.08 )
    -1.19 ( 3.27 )
    4.92 ( 4.29 )
    -2.49 ( 9.08 )
        Placebo
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    -2.85 ( 9.07 )
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    -2.85 ( 9.07 )
    Statistical analysis title
    		 AZD9567 72mg vs Prednisolone 40mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)
    Comparison groups
    Cohort 1 v Cohort 1
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 [45]
    P-value
    		 = 0.646
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.4
         upper limit
    		 5.95
    Notes
    [45] - 27 patients were evaluated in this analysis
    Statistical analysis title
    		 AZD9567 40mg vs Prednisolone 20mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)
    Comparison groups
    Cohort 2 v Cohort 2
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 [46]
    P-value
    		 = 0.11
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -10.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.39
         upper limit
    		 3.44
    Notes
    [46] - 8 patients were evaluated in this analysis
    Statistical analysis title
    		 Placebo vs Prednisolone 5mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)
    Comparison groups
    Cohort 3 v Cohort 3
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 other [47]
    P-value
    		 = 0.932
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.32
         upper limit
    		 9.61
    Notes
    [47] - 9 patients were evaluated in this analysis

    Secondary: Change from baseline in 24-hour urinary sodium concentration

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    End point title
    		 Change from baseline in 24-hour urinary sodium concentration
    End point description
    The concentration of sodium in urine was measured over 24 hours to determine the effect of AZD9567 on urinary-sodium (U-Na) excretion compared to prednisolone. The Subject Analysis set was added to report statistical analysis and this is the only option available in order to accommodate reporting of statistical data for cross over cohorts. Here, arbitrary value 9999.9999 represent not applicable. FAS consisted of all randomised patients who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    27
    8
    9
    27
    8
    9
    Units: mmol/day
    least squares mean (standard error)
        AZD9567
    17.4 ( 11.0 )
    39.9 ( 20.4 )
    9999.9999 ( 9999.9999 )
    17.4 ( 11.0 )
    39.9 ( 20.4 )
    9999.9999 ( 9999.9999 )
        Prednisolone
    9.7 ( 11.0 )
    17.6 ( 20.3 )
    -18.1 ( 21.4 )
    9.7 ( 11.0 )
    17.6 ( 20.3 )
    -18.1 ( 21.4 )
        Placebo
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    12.9 ( 21.3 )
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    12.9 ( 21.3 )
    Statistical analysis title
    		 AZD9567 72mg vs Prednisolone 40mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)
    Comparison groups
    Cohort 1 v Cohort 1
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other [48]
    P-value
    		 = 0.533
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.4
         upper limit
    		 32.7
    Notes
    [48] - 27 patients were evaluated in this analysis
    Statistical analysis title
    		 Placebo vs Prednisolone 5mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)
    Comparison groups
    Cohort 3 v Cohort 3
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 other [49]
    P-value
    		 = 0.204
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.9
         upper limit
    		 83.9
    Notes
    [49] - 9 patients were evaluated in this analysis
    Statistical analysis title
    		 AZD9567 40mg vs Prednisolone 20mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)
    Comparison groups
    Cohort 2 v Cohort 2
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other [50]
    P-value
    		 = 0.311
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    22.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.7
         upper limit
    		 71.3
    Notes
    [50] - 8 patients were evaluated in this analysis

    Secondary: Area under the plasma concentration versus time curve from zero to the last quantifiable concentration (AUClast)

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    End point title
    		 Area under the plasma concentration versus time curve from zero to the last quantifiable concentration (AUClast) [51]
    End point description
    AUClast of AZD9567 following once daily dosing was evaluated. Pharmacokinetic analysis set (PKAS) consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or adverse events (AEs) considered to have an effect upon PK.
    End point type
    Secondary
    End point timeframe
    On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)
    Notes
    [51] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not performed for the endpoint.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    27
    8
    Units: hour*nanomole/liter (h*nmol/L)
        geometric mean (geometric coefficient of variation)
    34400 ( 42.97 )
    18410 ( 46.06 )
    No statistical analyses for this end point

    Secondary: Area under the plasma concentration versus time curve from zero to 24 hours post-dose [AUC(0-24)]

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    End point title
    		 Area under the plasma concentration versus time curve from zero to 24 hours post-dose [AUC(0-24)] [52]
    End point description
    AUC(0-24) of AZD9567 following once daily dosing was evaluated. PKAS consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or AEs considered to have an effect upon PK.
    End point type
    Secondary
    End point timeframe
    On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)
    Notes
    [52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not performed for the endpoint.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    27
    8
    Units: h*nmol/L
        geometric mean (geometric coefficient of variation)
    32920 ( 41.32 )
    17790 ( 44.86 )
    No statistical analyses for this end point

    Secondary: Area under the plasma concentration versus time curve from zero to 6 hours post-dose [AUC(0-6)]

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    End point title
    		 Area under the plasma concentration versus time curve from zero to 6 hours post-dose [AUC(0-6)] [53]
    End point description
    AUC(0-6) of AZD9567 following once daily dosing was evaluated. PKAS consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or AEs considered to have an effect upon PK.
    End point type
    Secondary
    End point timeframe
    On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)
    Notes
    [53] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not performed for the endpoint.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    27
    8
    Units: h*nmol/L
        geometric mean (geometric coefficient of variation)
    17050 ( 30.45 )
    9914 ( 35.06 )
    No statistical analyses for this end point

    Secondary: Time to reach maximum observed drug concentration (tmax)

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    End point title
    		 Time to reach maximum observed drug concentration (tmax) [54]
    End point description
    Tmax of AZD9567 following once daily dosing was evaluated. PKAS consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or AEs considered to have an effect upon PK.
    End point type
    Secondary
    End point timeframe
    On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)
    Notes
    [54] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not performed for the endpoint.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    27
    8
    Units: hours
        median (full range (min-max))
    0.50 (0.25 to 1.50)
    0.50 (0.50 to 1.00)
    No statistical analyses for this end point

    Secondary: Apparent volume of distribution following extravascular administration (Vz/F)

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    End point title
    		 Apparent volume of distribution following extravascular administration (Vz/F) [55]
    End point description
    Vz/F of AZD9567 was derived using standard non-compartmental methods using WinNonLin version 8.1 or higher (Certara). PKAS consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or AEs considered to have an effect upon PK.
    End point type
    Secondary
    End point timeframe
    On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)
    Notes
    [55] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not performed for the endpoint.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    27
    8
    Units: Liter
        arithmetic mean (standard deviation)
    45.11 ( 11.39 )
    41.75 ( 14.19 )
    No statistical analyses for this end point

    Secondary: Apparent total body clearance of drug from plasma after extravascular (CL/F)

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    End point title
    		 Apparent total body clearance of drug from plasma after extravascular (CL/F) [56]
    End point description
    CL/F of AZD9567 following once daily dosing was evaluated. PKAS consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or AEs considered to have an effect upon PK.
    End point type
    Secondary
    End point timeframe
    On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)
    Notes
    [56] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not performed for the endpoint.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    27
    8
    Units: Liter/hour (L/h)
        arithmetic mean (standard deviation)
    4.766 ( 1.896 )
    4.924 ( 2.098 )
    No statistical analyses for this end point

    Secondary: Terminal elimination half-life (t½λz)

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    End point title
    		 Terminal elimination half-life (t½λz) [57]
    End point description
    t½λz of AZD9567 following once daily dosing was evaluated. PKAS consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or AEs considered to have an effect upon PK.
    End point type
    Secondary
    End point timeframe
    On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)
    Notes
    [57] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not performed for the endpoint.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    27
    8
    Units: hours
        arithmetic mean (standard deviation)
    6.99 ( 1.44 )
    6.16 ( 1.08 )
    No statistical analyses for this end point

    Secondary: Maximum observed drug concentration (Cmax)

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    End point title
    		 Maximum observed drug concentration (Cmax) [58]
    End point description
    Cmax of AZD9567 following once daily dosing was evaluated. PKAS consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or AEs considered to have an effect upon PK.
    End point type
    Secondary
    End point timeframe
    On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)
    Notes
    [58] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not performed for the endpoint.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    27
    8
    Units: nmol/L
        geometric mean (geometric coefficient of variation)
    4501 ( 26.90 )
    2939 ( 31.50 )
    No statistical analyses for this end point

    Secondary: Tumour necrosis factor alpha (TNFα) concentrations

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    End point title
    		 Tumour necrosis factor alpha (TNFα) concentrations [59]
    End point description
    Relationship between AZD9567 exposure and inhibition of LPS-stimulated TNFα release for high and low dose comparison (Cohort 1 and Cohort 2) was assessed. LPS-stimulated TNFα concentration was measured. FAS consisted of all randomised patients who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    On Days 3 (Treatment period 1 and 2)
    Notes
    [59] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not performed for the endpoint.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    27
    8
    Units: nanogram/liter (ng/L)
    arithmetic mean (standard deviation)
        AZD9567 (0h) (n= 26,8)
    21000.1 ( 15413.92 )
    23525.0 ( 15260.57 )
        Prednisolone (0h) (n= 26,8)
    21361.5 ( 18124.60 )
    12385.0 ( 11835.31 )
        AZD9567 (1h) (n= 26,8)
    9100.2 ( 6248.93 )
    8122.5 ( 5303.16 )
        Prednisolone (1h) (n=25,8)
    3581.1 ( 3642.93 )
    3617.5 ( 1552.62 )
        AZD9567 (2h) (n= 26,8)
    8170.7 ( 5053.69 )
    8098.0 ( 7709.06 )
        Prednisolone (2h) (n= 26,8)
    1648.2 ( 1109.64 )
    1421.1 ( 591.80 )
        AZD9567 (4h)
    7534.6 ( 4519.50 )
    8898.8 ( 5249.73 )
        Prednisolone (4h)
    2293.1 ( 1329.60 )
    4292.0 ( 3207.76 )
        AZD9567 (8h)
    10674.4 ( 7731.94 )
    13023.8 ( 8946.33 )
        Prednisolone (8h) (n= 26,8)
    4585.7 ( 4453.61 )
    7247.5 ( 2889.87 )
        AZD9567 (12h)
    13332.5 ( 10831.44 )
    14695.0 ( 11422.87 )
        Prednisolone (12h)
    12415.5 ( 9474.44 )
    16790.0 ( 8010.23 )
        AZD9567 (24h)
    22136.7 ( 13414.45 )
    19741.3 ( 11048.74 )
        Prednisolone (24h)
    23292.9 ( 15548.12 )
    20920.0 ( 14802.66 )
    No statistical analyses for this end point

    Secondary: Change from baseline AUC(0‑4) on hormones related to glucose homeostasis (Free fatty acids)

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    End point title
    		 Change from baseline AUC(0‑4) on hormones related to glucose homeostasis (Free fatty acids)
    End point description
    Effects of AZD9567 on free fatty acids were evaluated following a MMTT compared to prednisolone. The Subject Analysis set was added to report statistical analysis and this is the only option available in order to accommodate reporting of statistical data for cross over cohorts. Here, arbitrary value 9999.9999 represent not applicable. FAS consisted of all randomised patients who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)
    End point values
    		 Cohort 1 Cohort 2 Cohort 3 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    27
    8
    9
    27
    8
    9
    Units: min*mmol/L
    least squares mean (standard error)
        AZD9567
    -18.1304 ( 1.7543 )
    -14.0582 ( 3.7038 )
    9999.9999 ( 9999.9999 )
    -18.1304 ( 1.7543 )
    -14.0582 ( 3.7038 )
    9999.9999 ( 9999.9999 )
        Prednisolone
    -14.1238 ( 1.7542 )
    -19.8117 ( 3.7060 )
    -4.1625 ( 3.7212 )
    -14.1238 ( 1.7542 )
    -19.8117 ( 3.7060 )
    -4.1625 ( 3.7212 )
        Placebo
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    4.8995 ( 3.7153 )
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    4.8995 ( 3.7153 )
    Statistical analysis title
    		 AZD9567 72mg vs Prednisolone 40mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)
    Comparison groups
    Cohort 1 v Cohort 1
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other [60]
    P-value
    		 = 0.103
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.88
         upper limit
    		 0.87
    Notes
    [60] - 27 patients were evaluated in this analysis
    Statistical analysis title
    		 Placebo vs Prednisolone 5mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)
    Comparison groups
    Cohort 3 v Cohort 3
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 other [61]
    P-value
    		 = 0.023
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    9.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.67
         upper limit
    		 16.44
    Notes
    [61] - 9 patients were evaluated in this analysis
    Statistical analysis title
    		 AZD9567 40mg vs Prednisolone 20mg
    Statistical analysis description
    Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)
    Comparison groups
    Cohort 2 v Cohort 2
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other [62]
    P-value
    		 = 0.005
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.7535
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.6034
         upper limit
    		 8.9036
    Notes
    [62] - 8 patients were evaluated in this analysis

    Secondary: Homeostatic model assessment- insulin resistance (HOMA-IR)

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    End point title
    		 Homeostatic model assessment- insulin resistance (HOMA-IR)
    End point description
    The HOMA-IR was calculated based on glucose and insulin measured prior to MMTT. HOMA-IR= Glucose(mmol/L) x Insulin (mU/L) / 22.5 HOMA-IR score estimates the degree of insulin resistance. Higher range indicates greater insulin resistance (i.e. high diabetes risk), while lower range indicates insulin sensitivity (i.e. low diabetes risk) Here, arbitrary value 9999.9999 represent not applicable. FAS consisted of all randomised patients who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)
    End point values
    		 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    27
    8
    9
    Units: Change from Baseline
    arithmetic mean (standard deviation)
        AZD9567 (n= 26,8,9)
    -0.4406 ( 1.9875 )
    -0.1738 ( 0.7576 )
    9999.9999 ( 9999.9999 )
        Prednisolone (n= 25,8,9)
    -0.7023 ( 1.5896 )
    0.0721 ( 0.9606 )
    -0.5662 ( 0.7364 )
        Placebo
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    -0.9280 ( 0.8173 )
    No statistical analyses for this end point

    Secondary: Number of participants with adverse events

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    End point title
    		 Number of participants with adverse events
    End point description
    Safety and tolerability of AZD9567 was assessed. IP: Investigational product Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    From screening up to 79 days
    End point values
    		 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    27
    8
    9
    Units: Participants
        Any Adverse Event (AE)
    10
    5
    1
        Any AE with outcome = death
    0
    0
    0
        Any SAE (including events with outcome = death)
    0
    0
    0
        Any AE leading to discontinuation of IP
    0
    0
    0
        Any AE leading to drug interruption
    0
    0
    0
        Any AE leading to withdrawal from study
    0
    0
    0
    No statistical analyses for this end point

    Secondary: HOMA-insulin sensitivity (HOMA-S)

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    End point title
    		 HOMA-insulin sensitivity (HOMA-S)
    End point description
    Insulin sensitivity is a term used to indicate the responsiveness of the peripheral tissue cells to insulin, and their resultant capacity to uptake glucose out of the bloodstream. HOMA-S score estimates the degree of insulin sensitivity. HOMA-S was calculated as the reciprocal of HOMA-IR. Higher values indicates greater insulin sensitivity (i.e. low diabetes risk), while lower values indicates insulin resistance (i.e. high diabetes risk) Here, arbitrary value 9999.9999 represent not applicable. FAS consisted of all randomised patients who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)
    End point values
    		 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    27
    8
    9
    Units: Change from Baseline
    arithmetic mean (standard deviation)
        AZD9567 (n= 26,8,9)
    0.0134 ( 0.2352 )
    -0.0360 ( 0.1990 )
    9999.9999 ( 9999.9999 )
        Prednisolone (n= 25,8,9)
    0.0328 ( 0.1400 )
    -0.0799 ( 0.2077 )
    0.0750 ( 0.0949 )
        Placebo
    9999.9999 ( 9999.9999 )
    9999.9999 ( 9999.9999 )
    0.1468 ( 0.0930 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Screening up to Final/ end of treatment visit (Day 79).
    Adverse event reporting additional description
    Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Cohort 1: AZD9567 72mg
    Reporting group description
    		 Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD956

    Reporting group title
    Cohort 2: AZD9567 40mg
    Reporting group description
    		 Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567

    Reporting group title
    Cohort 3: Prednisolone 5mg
    Reporting group description
    		 Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo

    Reporting group title
    Cohort 1: Prednisolone 40mg
    Reporting group description
    		 Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD956

    Reporting group title
    Cohort 2: Prednisolone 20mg
    Reporting group description
    		 Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD956

    Reporting group title
    Cohort 3: Placebo
    Reporting group description
    		 Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo

    Serious adverse events
    		 Cohort 1: AZD9567 72mg Cohort 2: AZD9567 40mg Cohort 3: Prednisolone 5mg Cohort 1: Prednisolone 40mg Cohort 2: Prednisolone 20mg Cohort 3: Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 27 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Cohort 1: AZD9567 72mg Cohort 2: AZD9567 40mg Cohort 3: Prednisolone 5mg Cohort 1: Prednisolone 40mg Cohort 2: Prednisolone 20mg Cohort 3: Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 27 (14.81%)
    2 / 8 (25.00%)
    0 / 9 (0.00%)
    7 / 27 (25.93%)
    5 / 8 (62.50%)
    1 / 9 (11.11%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 27 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    1 / 27 (3.70%)
    2 / 8 (25.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    1
    2
    0
    Dizziness
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 27 (3.70%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    General disorders and administration site conditions
    Administration site phlebitis
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 27 (3.70%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Catheter site related reaction
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 27 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Catheter site erythema
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 27 (3.70%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 27 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Mucosal inflammation
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 27 (3.70%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Haematochezia
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 27 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 27 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 27 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 27 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 27 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 27 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Cellulitis
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 27 (3.70%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 27 (3.70%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Hypoglycaemia
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 27 (3.70%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Arbitrary value 9999.9999 represent not applicable due to Placebo/AZD9567 was not administered in that cohort. For Outcome measure MMTT derived first phase insulin response (l10/G10]), in cohort 2, convergence was not met thus no data was available.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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