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    Clinical Trial Results:
    A Phase 2 Trial to Assess the Efficacy and Safety of M1 Pram P037 prandial insulin in T1DM subjects

    Summary
    EudraCT number
    		 2020-000444-58
    Trial protocol
    		 DE  
    Global end of trial date
    24 Feb 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Apr 2023
    First version publication date
    05 Apr 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CT041-ADO09
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04816890
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Adocia
    Sponsor organisation address
    115 Avenue Lacassagne, LYON, France, 69003
    Public contact
    Deputy General Manager, Adocia, +33 472610610, o.soula@adocia.com
    Scientific contact
    Deputy General Manager, Adocia, +33 472610610, o.soula@adocia.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
    15 Feb 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Feb 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Feb 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of prandial use of M1 Pram P037 with insulin lispro on body weight change after 16 weeks of optimised titration, in combination with a basal insulin.
    Protection of trial subjects
    The trial was conducted in accordance with the declaration of Helsinki and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceutical Use (ICH) Good Clinical Practices
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Mar 2021
    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: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    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)
    80
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at one site in Germany.

    Pre-assignment
    Screening details
    		 -Signed and dated informed consent -Subject with type 1 diabetes mellitus -Age between 18 and 64 years -BMI between 25.0 and 35.0 kg/m² -HbA1C between 7.0% and 9.5% -Using a multiple dosing insulin therapy (MDI) with a basal insulin and a rapid-acting insulin at, at least, two meals per day.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not Applicable. Open label trial

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 M1 Pram P037
    Arm description
    		 After a screening visit to assess eligibility for participation, a run-in period (if applicable, for subjects using a basal insulin other than glargine or degludec at screening and/or not familiar with the CGM system used in the trial), and 3-week baseline-recording period, subjects entered a 16 weeks treatment period with M1 Pram P037 as multiple dose administrations, in combination with insulin glargine or insulin degludec, according to their individual needs. Subjects blood glucose was constantly monitored and recorded by a CGM. A data monitoring committee with previous expertise in pramlintide treatments reviewed CGM data of subjects throughout the 4-month trial period for monitoring safety and efficacy data of the treatments and advising the investigator on the adjustment of M1 Pram P037 and basal insulin doses for each subject. Body weight and HbA1c were measured at Day 0 and after 1 month, 2 months, 3 months, and 4 months of treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    M1 Pram P037
    Investigational medicinal product code
    Other name
    Co-formulation of insulin M1 and pramlintide
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Multiple daily administration of M1 Pram injected subcutaneously under the abdominal skin. Dose were defined according to subjects requirements and adjusted by the Data Monitoring Committee after review of the CGM data.

    Arm title
    		 Humalog®
    Arm description
    		 After a screening visit to assess eligibility for participation, a run-in period (if applicable, for subjects using a basal insulin other than glargine or degludec at screening and/or not familiar with the CGM system used in the trial), and 3-week baseline-recording period, subjects entered a 16 weeks treatment period with Humalog® as multiple dose administrations, in combination with insulin glargine or insulin degludec, according to their individual needs. Subjects blood glucose was constantly monitored and recorded by a CGM. A data monitoring committee with previous expertise in pramlintide treatments reviewed CGM data of subjects throughout the 4-month trial period for monitoring safety and efficacy data of the treatments and advising the investigator on the adjustment of Humalog® and basal insulin doses for each subject. Body weight and HbA1c were measured at Day 0 and after 1 month, 2 months, 3 months, and 4 months of treatment.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Humalog®
    Investigational medicinal product code
    Other name
    Insulin lispro
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Multiple daily administration of Humalog® injected subcutaneously under the abdominal skin. Dose were defined according to subjects requirements and adjusted by the Data Monitoring Committee after review of the CGM data.

    Number of subjects in period 1
    		M1 Pram P037 Humalog®
    Started
    40
    40
    Completed
    34
    37
    Not completed
    6
    3
         Consent withdrawn by subject
    4
    2
         Physician decision
    1
    1
         Adverse event, non-fatal
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    M1 Pram P037
    Reporting group description
    		 After a screening visit to assess eligibility for participation, a run-in period (if applicable, for subjects using a basal insulin other than glargine or degludec at screening and/or not familiar with the CGM system used in the trial), and 3-week baseline-recording period, subjects entered a 16 weeks treatment period with M1 Pram P037 as multiple dose administrations, in combination with insulin glargine or insulin degludec, according to their individual needs. Subjects blood glucose was constantly monitored and recorded by a CGM. A data monitoring committee with previous expertise in pramlintide treatments reviewed CGM data of subjects throughout the 4-month trial period for monitoring safety and efficacy data of the treatments and advising the investigator on the adjustment of M1 Pram P037 and basal insulin doses for each subject. Body weight and HbA1c were measured at Day 0 and after 1 month, 2 months, 3 months, and 4 months of treatment.

    Reporting group title
    Humalog®
    Reporting group description
    		 After a screening visit to assess eligibility for participation, a run-in period (if applicable, for subjects using a basal insulin other than glargine or degludec at screening and/or not familiar with the CGM system used in the trial), and 3-week baseline-recording period, subjects entered a 16 weeks treatment period with Humalog® as multiple dose administrations, in combination with insulin glargine or insulin degludec, according to their individual needs. Subjects blood glucose was constantly monitored and recorded by a CGM. A data monitoring committee with previous expertise in pramlintide treatments reviewed CGM data of subjects throughout the 4-month trial period for monitoring safety and efficacy data of the treatments and advising the investigator on the adjustment of Humalog® and basal insulin doses for each subject. Body weight and HbA1c were measured at Day 0 and after 1 month, 2 months, 3 months, and 4 months of treatment.

    Reporting group values
    		 M1 Pram P037 Humalog® Total
    Number of subjects
    		 40 40 80
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 40 40 80
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 11 6 17
        Male
    		 29 34 63

    End points

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    End points reporting groups
    Reporting group title
    M1 Pram P037
    Reporting group description
    		 After a screening visit to assess eligibility for participation, a run-in period (if applicable, for subjects using a basal insulin other than glargine or degludec at screening and/or not familiar with the CGM system used in the trial), and 3-week baseline-recording period, subjects entered a 16 weeks treatment period with M1 Pram P037 as multiple dose administrations, in combination with insulin glargine or insulin degludec, according to their individual needs. Subjects blood glucose was constantly monitored and recorded by a CGM. A data monitoring committee with previous expertise in pramlintide treatments reviewed CGM data of subjects throughout the 4-month trial period for monitoring safety and efficacy data of the treatments and advising the investigator on the adjustment of M1 Pram P037 and basal insulin doses for each subject. Body weight and HbA1c were measured at Day 0 and after 1 month, 2 months, 3 months, and 4 months of treatment.

    Reporting group title
    Humalog®
    Reporting group description
    		 After a screening visit to assess eligibility for participation, a run-in period (if applicable, for subjects using a basal insulin other than glargine or degludec at screening and/or not familiar with the CGM system used in the trial), and 3-week baseline-recording period, subjects entered a 16 weeks treatment period with Humalog® as multiple dose administrations, in combination with insulin glargine or insulin degludec, according to their individual needs. Subjects blood glucose was constantly monitored and recorded by a CGM. A data monitoring committee with previous expertise in pramlintide treatments reviewed CGM data of subjects throughout the 4-month trial period for monitoring safety and efficacy data of the treatments and advising the investigator on the adjustment of Humalog® and basal insulin doses for each subject. Body weight and HbA1c were measured at Day 0 and after 1 month, 2 months, 3 months, and 4 months of treatment.

    Primary: Body Weight change

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    End point title
    		 Body Weight change
    End point description
    End point type
    Primary
    End point timeframe
    From Baseline to Week 16
    End point values
    		 M1 Pram P037 Humalog®
    Number of subjects analysed
    34
    37
    Units: kg
        arithmetic mean (standard deviation)
    -2.51 ( 3.008 )
    -0.45 ( 3.116 )
    Statistical analysis title
    		 M1 Pram vs Humalog®
    Comparison groups
    Humalog® v M1 Pram P037
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.0045
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference
    Point estimate
    -2.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.5779
         upper limit
    		 -0.6848
    Notes
    [1] - Difference between M1 Pram and Humalog®
    Statistical analysis title
    		 M1 Pram vs Humalog® Sensitivity Analysis
    Statistical analysis description
    One outlier subject in Humalog® arm (out of 37) excluded from analysis following an adverse event (gluteal abcess) leading to hospitalization and 11 kg weight loss.
    Comparison groups
    M1 Pram P037 v Humalog®
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.0006
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference
    Point estimate
    -2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.7349
         upper limit
    		 -1.0721
    Notes
    [2] - Difference between M1 Pram and Humalog®

    Secondary: HbA1C change

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    End point title
    		 HbA1C change
    End point description
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16
    End point values
    		 M1 Pram P037 Humalog®
    Number of subjects analysed
    34
    37
    Units: Percentage
        arithmetic mean (standard deviation)
    0.14 ( 0.511 )
    0.10 ( 0.508 )
    Statistical analysis title
    		 M1 Pram vs Humalog®
    Comparison groups
    Humalog® v M1 Pram P037
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.8127
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2122
         upper limit
    		 0.2697
    Notes
    [3] - Difference between M1 Pram and Humalog

    Secondary: TiR [70-180] mg/dL

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    End point title
    		 TiR [70-180] mg/dL
    End point description
    Time in Range (TiR) [70–180] mg/dL, change from baseline to week 16 of treatment
    End point type
    Secondary
    End point timeframe
    From baseline to week 16 of treatment
    End point values
    		 M1 Pram P037 Humalog®
    Number of subjects analysed
    26
    26
    Units: Hour
        arithmetic mean (standard deviation)
    -0.76 ( 2.103 )
    -0.37 ( 2.128 )
    Statistical analysis title
    		 M1 Pram vs Humalog®
    Comparison groups
    Humalog® v M1 Pram P037
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0.2907
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7423
         upper limit
    		 0.5329
    Notes
    [4] - Difference

    Secondary: Prandial Insulin dose

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    End point title
    		 Prandial Insulin dose
    End point description
    Change in daily prandial insulin dose between start and end of treatment
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16 of treatment
    End point values
    		 M1 Pram P037 Humalog®
    Number of subjects analysed
    34
    37
    Units: Units/day
        arithmetic mean (standard deviation)
    -5.97 ( 6.184 )
    -0.61 ( 7.077 )
    Statistical analysis title
    		 M1 Pram vs Humalog®
    Comparison groups
    Humalog® v M1 Pram P037
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.0012
    Method
    		 Hodges' and Lehmann's Rank Sum Test
    Parameter type
    		 Point estimate of Hodges and lehman
    Point estimate
    -4.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.3333
         upper limit
    		 -1.9667
    Notes
    [5] - Difference between M1 Pram and Humalog®

    Secondary: Mean Glucose Change

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    End point title
    		 Mean Glucose Change
    End point description
    Mean glucose change per day as measured by CGM.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 16 of treatment
    End point values
    		 M1 Pram P037 Humalog®
    Number of subjects analysed
    26
    26
    Units: mg/dL
        arithmetic mean (standard deviation)
    1.30 ( 13.235 )
    1.60 ( 14.970 )
    Statistical analysis title
    		 M1 Pram vs Humalog®
    Comparison groups
    Humalog® v M1 Pram P037
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 = 0.8996
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference
    Point estimate
    0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.0644
         upper limit
    		 8.0157
    Notes
    [6] - Difference between M1 Pram and Humalog®

    Secondary: Total Insulin dose

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    End point title
    		 Total Insulin dose
    End point description
    Change in total insulin dose between start and end of treatment
    End point type
    Secondary
    End point timeframe
    From Baseline to week 16 of treatment
    End point values
    		 M1 Pram P037 Humalog®
    Number of subjects analysed
    34
    37
    Units: Units/day
        arithmetic mean (standard deviation)
    -6.02 ( 6.872 )
    1.12 ( 7.247 )
    Statistical analysis title
    		 M1 Pram vs Humalog®
    Comparison groups
    M1 Pram P037 v Humalog®
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0.0002
    Method
    		 Hodges and Lehman's rank sum test
    Parameter type
    		 Point estimate of Hodges and Lehmann
    Point estimate
    -6.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.2214
         upper limit
    		 -3.3143
    Notes
    [7] - Difference between M1 Pram and Humalog®

    Post-hoc: Body weight change in subject with BMI≥30 at screening

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    End point title
    		 Body weight change in subject with BMI≥30 at screening
    End point description
    Body weight change after 16 weeks of treatment in the subgroup of patient who presented a BMI ≥30kg/m² at the screening visit
    End point type
    Post-hoc
    End point timeframe
    From Baseline to Week 16
    End point values
    		 M1 Pram P037 Humalog®
    Number of subjects analysed
    7
    9
    Units: Kg
        arithmetic mean (standard deviation)
    -5.56 ( 2.870 )
    -0.57 ( 3.600 )
    Statistical analysis title
    		 M1 Pram vs Humalog®
    Comparison groups
    Humalog® v M1 Pram P037
    Number of subjects included in analysis
    16
    Analysis specification
    Post-hoc
    Analysis type
    		 other [8]
    P-value
    		 = 0.0009
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference
    Point estimate
    -5.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.2121
         upper limit
    		 -2.2225
    Notes
    [8] - Difference between M1 pram and Humalog®

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first treatment dose to follow-up visit after the 16 weeks treatment period. (Treatment Emergent Adverse Events)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    M1 Pram
    Reporting group description
    		 Subjects who received at least 1 dose of M1 Pram after randomization

    Reporting group title
    Humalog®
    Reporting group description
    		 Subjects who received at least on dose of Humalog® after randomization

    Serious adverse events
    		 M1 Pram Humalog®
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 40 (10.00%)
    3 / 40 (7.50%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Endocrine disorders
    Hypoglycaemia
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 40 (5.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 M1 Pram Humalog®
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 40 (97.50%)
    33 / 40 (82.50%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Application site erythema
         subjects affected / exposed
    1 / 40 (2.50%)
    3 / 40 (7.50%)
         occurrences all number
    1
    3
    Application site haematoma
         subjects affected / exposed
    1 / 40 (2.50%)
    3 / 40 (7.50%)
         occurrences all number
    1
    3
    Application site irritation
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Application site pruritus
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Chills
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 40 (5.00%)
         occurrences all number
    2
    2
    Hyperhidrosis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Injection site reaction
         subjects affected / exposed
    3 / 40 (7.50%)
    0 / 40 (0.00%)
         occurrences all number
    4
    0
    Malaise
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Nasopharyngitis
         subjects affected / exposed
    10 / 40 (25.00%)
    6 / 40 (15.00%)
         occurrences all number
    10
    7
    Rhinitis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Panic attack
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Myocardial necrosis marker increased
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Application site erythema
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Application site haemorrhage
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Contusion
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    5 / 40 (12.50%)
    5 / 40 (12.50%)
         occurrences all number
    7
    5
    Restlessness
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Visual field defect
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    6 / 40 (15.00%)
    1 / 40 (2.50%)
         occurrences all number
    7
    1
    Dyspepsia
         subjects affected / exposed
    3 / 40 (7.50%)
    0 / 40 (0.00%)
         occurrences all number
    3
    0
    Eructation
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Food poisoning
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    9 / 40 (22.50%)
    1 / 40 (2.50%)
         occurrences all number
    10
    1
    Toothache
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2
    Rash
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hypoglycaemia
         subjects affected / exposed
    33 / 40 (82.50%)
    31 / 40 (77.50%)
         occurrences all number
    351
    344
    Musculoskeletal and connective tissue disorders
    Ankle fracture
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Arthralgia
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 40 (5.00%)
         occurrences all number
    2
    2
    Back pain
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Bursitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Ligament injury
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 40 (15.00%)
    1 / 40 (2.50%)
         occurrences all number
    6
    1
    Early satiety
         subjects affected / exposed
    3 / 40 (7.50%)
    0 / 40 (0.00%)
         occurrences all number
    3
    0

    More information

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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.
    None reported
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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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