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    Clinical Trial Results:
    A Phase II, 16-week, double-blind, placebo-controlled, parallel-group, randomised, multicentre trial to assess effect on glycaemic control of three doses of HM11260C in subjects with inadequately controlled type 2 diabetes receiving a stable dose of metformin

    Summary
    EudraCT number
    		 2013-004250-13
    Trial protocol
    		 DE   HU   ES   IT  
    Global end of trial date
    30 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Nov 2016
    First version publication date
    06 Nov 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HM-EXC-204
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02081118
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hanmi Pharmaceutical Co., Ltd.
    Sponsor organisation address
    14, Wiryeseong-daero, Songpa-gu, Seoul, Korea, Republic of, 05545
    Public contact
    Jahoon Kang, Executive Director of Clinical Research and Development, Hanmi Pharmaceutical Co. Ltd., +82 2-410-9041, jhkang@hanmi.co.kr
    Scientific contact
    Jahoon Kang, Executive Director of Clinical Research and Development, Hanmi Pharmaceutical Co., Ltd., +82 2-410-9041, jhkang@hanmi.co.kr
    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
    01 Oct 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess and compare the efficacy of three doses of HM11260C (once monthly dosing) versus placebo on glycaemic control as assessed by the change in HbA1c over the 16 weeks from baseline in subjects with T2DM receiving a stable dose of metformin
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with ICH GCP ensuring that those involved with the conduct of the study abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    		 Metformin
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Feb 2014
    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
    Spain: 12
    Country: Number of subjects enrolled
    Germany: 21
    Country: Number of subjects enrolled
    Hungary: 9
    Country: Number of subjects enrolled
    Korea, Republic of: 2
    Country: Number of subjects enrolled
    United States: 165
    Worldwide total number of subjects
    209
    EEA total number of subjects
    42
    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)
    176
    From 65 to 84 years
    33
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment from 18-Feb 2014 (First Patient In Screened) to 29th Oct 2014 (LPI Screened), Last patient last visit was 30-Apr-2015 - Regions- US, Europe (Hungary, Spain, Germany, Italy) and Asia (South Korea)

    Pre-assignment
    Screening details
    		 209 subjects were randomized. 4-week screening period, a 16-week treatment period, and a 6-week follow-up period. The screening visits took place between Study Days -28 and -5. Eligible subjects who met all of the inclusion criteria and none of the exclusion criteria returned to the clinic on Day 1 for baseline, randomisation, and study drug use.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    HM11260C and placebo for HM11260C were provided in identically matched prefilled syringe and packaged identically.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 HM11260C (8 mg)
    Arm description
    		 subcutaneous (sc) HM11260C 4 mg once a week (QW) for 4 weeks, then 8 mg QW for 1 week, then 8 mg once a month (every 28 days) for 2 months
    Arm type
    		 Experimental

    Investigational medicinal product name
    Long-acting CA Exendin-4-HMC001 conjugate
    Investigational medicinal product code
    HM11260C
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.53 ml of HM11260C was self administered by subcutaneous injection within 60 minutes before the meal using pre-filled syringe.

    Arm title
    		 HM11260C (12 mg)
    Arm description
    		 subcutaneous (sc) HM11260C 4 mg once a week (QW) for 4 weeks, then 8 mg QW for 1 week, then 12 mg once a month (every 28 days) for 2 months
    Arm type
    		 Experimental

    Investigational medicinal product name
    Long-acting CA Exendin-4-HMC001 conjugate
    Investigational medicinal product code
    HM11260C
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.53 ml of HM11260C was self administered by subcutaneous injection within 60 minutes before the meal using pre-filled syringe.

    Arm title
    		 HM11260C (16 mg)
    Arm description
    		 subcutaneous (sc) HM11260C 4 mg once a week (QW) for 4 weeks, then 8 mg QW for 1 week, then 16 mg once a month (every 28 days) for 2 months
    Arm type
    		 Experimental

    Investigational medicinal product name
    Long-acting CA Exendin-4-HMC001 conjugate
    Investigational medicinal product code
    HM11260C
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.53 ml of HM11260C was self administered by subcutaneous injection within 60 minutes before the meal using pre-filled syringe.

    Arm title
    		 Placebo
    Arm description
    		 subcutaneous (sc) placebo identical in appearance and volume to HM11260C once a week (QW) for 5 weeks, then placebo once a month (every 28 days) for 2 months
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.53 ml of Placebo was self administered by subcutaneous injection within 60 minutes before the meal using pre-filled syringe.

    Number of subjects in period 1 [1]
    		HM11260C (8 mg) HM11260C (12 mg) HM11260C (16 mg) Placebo
    Started
    52
    52
    53
    50
    Completed
    41
    39
    37
    41
    Not completed
    11
    13
    16
    9
         Adverse event, non-fatal
    6
    6
    8
    1
         Other
    1
    -
    -
    -
         Pregnancy
    -
    1
    -
    -
         Lost to follow-up
    -
    3
    4
    3
         Protocol deviation
    1
    -
    -
    1
         Withdrawal by subject
    3
    2
    3
    3
         Noncompliance
    -
    1
    1
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 209 subjects were randomised at 45 investigative sites. Of these, 158 subjects were randomised to HM11260C overall and 51 to placebo. A total of 207 subjects received study drug (HM11260C or placebo) and were included in the Safety Set.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HM11260C (8 mg)
    Reporting group description
    		 subcutaneous (sc) HM11260C 4 mg once a week (QW) for 4 weeks, then 8 mg QW for 1 week, then 8 mg once a month (every 28 days) for 2 months

    Reporting group title
    HM11260C (12 mg)
    Reporting group description
    		 subcutaneous (sc) HM11260C 4 mg once a week (QW) for 4 weeks, then 8 mg QW for 1 week, then 12 mg once a month (every 28 days) for 2 months

    Reporting group title
    HM11260C (16 mg)
    Reporting group description
    		 subcutaneous (sc) HM11260C 4 mg once a week (QW) for 4 weeks, then 8 mg QW for 1 week, then 16 mg once a month (every 28 days) for 2 months

    Reporting group title
    Placebo
    Reporting group description
    		 subcutaneous (sc) placebo identical in appearance and volume to HM11260C once a week (QW) for 5 weeks, then placebo once a month (every 28 days) for 2 months

    Reporting group values
    		 HM11260C (8 mg) HM11260C (12 mg) HM11260C (16 mg) Placebo Total
    Number of subjects
    		 52 52 53 50 207
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.7 ( 8.05 ) 56 ( 9.51 ) 56.4 ( 9.52 ) 54.7 ( 9.94 ) -
    Gender categorical
    Units: Subjects
        Female
    		 19 28 25 23 95
        Male
    		 33 24 28 27 112

    End points

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    End points reporting groups
    Reporting group title
    HM11260C (8 mg)
    Reporting group description
    		 subcutaneous (sc) HM11260C 4 mg once a week (QW) for 4 weeks, then 8 mg QW for 1 week, then 8 mg once a month (every 28 days) for 2 months

    Reporting group title
    HM11260C (12 mg)
    Reporting group description
    		 subcutaneous (sc) HM11260C 4 mg once a week (QW) for 4 weeks, then 8 mg QW for 1 week, then 12 mg once a month (every 28 days) for 2 months

    Reporting group title
    HM11260C (16 mg)
    Reporting group description
    		 subcutaneous (sc) HM11260C 4 mg once a week (QW) for 4 weeks, then 8 mg QW for 1 week, then 16 mg once a month (every 28 days) for 2 months

    Reporting group title
    Placebo
    Reporting group description
    		 subcutaneous (sc) placebo identical in appearance and volume to HM11260C once a week (QW) for 5 weeks, then placebo once a month (every 28 days) for 2 months

    Primary: Change from Baseline in HbA1c

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    End point title
    		 Change from Baseline in HbA1c
    End point description
    Least squares (LS) means and standard errors at Week 17 were obtained from a mixed effect model with repeated measures (MMRM). Full Analysis Set (FAS) population: all participants who received study drug and had at least 1 efficacy or safety assessment recorded after dosing.
    End point type
    Primary
    End point timeframe
    Week 17
    End point values
    		 HM11260C (8 mg) HM11260C (12 mg) HM11260C (16 mg) Placebo
    Number of subjects analysed
    52
    52
    52
    49
    Units: Percentage of Hemoglobin
        least squares mean (standard error)
    -0.98 ( 0.118 )
    -0.99 ( 0.119 )
    -1.11 ( 0.122 )
    -0.32 ( 0.119 )
    Statistical analysis title
    		 Change from baseline in HbA1c for 8 mg vs placebo
    Comparison groups
    Placebo v HM11260C (8 mg)
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.0001
    Method
    		 Mixed Model Repeated Measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.66
    Confidence interval
         level
    		 95.1%
         sides
    2-sided
         lower limit
    		 -0.99
         upper limit
    		 -0.33
    Variability estimate
    Standard error of the mean
    Notes
    [1] - The threshold for significance is a p-value <=0.049. No adjustments were made for multiple comparisons of each treatment group to placebo.
    Statistical analysis title
    		 Change from baseline in HbA1c for 12 mg vs placebo
    Comparison groups
    Placebo v HM11260C (12 mg)
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.0001
    Method
    		 Mixed Model Repeated Measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.67
    Confidence interval
         level
    		 95.1%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 -0.34
    Variability estimate
    Standard error of the mean
    Notes
    [2] - The threshold for significance is a p-value <=0.049. No adjustments were made for multiple comparisons of each treatment group to placebo.
    Statistical analysis title
    		 Change from baseline in HbA1c for 16 mg vs placebo
    Comparison groups
    HM11260C (16 mg) v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.0001
    Method
    		 Mixed Model Repeated Measures
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.79
    Confidence interval
         level
    		 95.1%
         sides
    2-sided
         lower limit
    		 -1.13
         upper limit
    		 -0.45
    Variability estimate
    Standard error of the mean
    Notes
    [3] - The threshold for significance is a p-value <=0.049. No adjustments were made for multiple comparisons of each treatment group to placebo.

    Secondary: Subjects who had a HbA1c level of < 7%

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    End point title
    		 Subjects who had a HbA1c level of < 7%
    End point description
    Percentage of subjects with HbA1c < 7% by visit, treatment group. FAS population.
    End point type
    Secondary
    End point timeframe
    Week 17
    End point values
    		 HM11260C (8 mg) HM11260C (12 mg) HM11260C (16 mg) Placebo
    Number of subjects analysed
    52
    52
    52
    49
    Units: Percentage
        number (not applicable)
    50
    50
    46.2
    30.6
    No statistical analyses for this end point

    Secondary: Change from Baseline in Fasting Plasma Glucose

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    End point title
    		 Change from Baseline in Fasting Plasma Glucose
    End point description
    Least squares (LS) means and standard errors at Week 17 were obtained from a mixed effect model with repeated measures (MMRM). FAS population.
    End point type
    Secondary
    End point timeframe
    Week 17
    End point values
    		 HM11260C (8 mg) HM11260C (12 mg) HM11260C (16 mg) Placebo
    Number of subjects analysed
    52
    52
    52
    49
    Units: mmol/L
        least squares mean (standard error)
    -0.78 ( 0.285 )
    -0.45 ( 0.291 )
    -0.79 ( 0.296 )
    -0.07 ( 0.282 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Body Weight

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    End point title
    		 Change from Baseline in Body Weight
    End point description
    Least squares (LS) means and standard errors at Week 17 were obtained from a mixed effect model with repeated measures (MMRM). FAS population.
    End point type
    Secondary
    End point timeframe
    Week 17
    End point values
    		 HM11260C (8 mg) HM11260C (12 mg) HM11260C (16 mg) Placebo
    Number of subjects analysed
    52
    52
    52
    49
    Units: kilogram(s)
        least squares mean (standard error)
    -2.11 ( 0.504 )
    -3.16 ( 0.505 )
    -2.7 ( 0.526 )
    -0.51 ( 0.503 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Other diabetes-related parameters (fasting insulin)

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    End point title
    		 Change from Baseline in Other diabetes-related parameters (fasting insulin)
    End point description
    Least squares (LS) means and standard errors at Week 17 were obtained from a mixed effect model with repeated measures (MMRM). FAS population.
    End point type
    Secondary
    End point timeframe
    Week 17
    End point values
    		 HM11260C (8 mg) HM11260C (12 mg) HM11260C (16 mg) Placebo
    Number of subjects analysed
    52
    52
    52
    49
    Units: pmol/L
        least squares mean (standard error)
    -14.77 ( 9.819 )
    1.28 ( 9.913 )
    1.86 ( 9.891 )
    -6.4 ( 9.336 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Other diabetes-related parameters (C-peptide)

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    End point title
    		 Change from Baseline in Other diabetes-related parameters (C-peptide)
    End point description
    Least squares (LS) means and standard errors at Week 17 were obtained from a mixed effect model with repeated measures (MMRM). FAS population.
    End point type
    Secondary
    End point timeframe
    Week 17
    End point values
    		 HM11260C (8 mg) HM11260C (12 mg) HM11260C (16 mg) Placebo
    Number of subjects analysed
    52
    52
    52
    49
    Units: nmol/L
        least squares mean (standard error)
    0.014 ( 0.023 )
    0.013 ( 0.023 )
    0.036 ( 0.023 )
    0.027 ( 0.021 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Other diabetes-related parameters (Glycated Albumin)

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    End point title
    		 Change from Baseline in Other diabetes-related parameters (Glycated Albumin)
    End point description
    Least squares (LS) means and standard errors at Week 17 were obtained from a mixed effect model with repeated measures (MMRM). FAS population.
    End point type
    Secondary
    End point timeframe
    Week 17
    End point values
    		 HM11260C (8 mg) HM11260C (12 mg) HM11260C (16 mg) Placebo
    Number of subjects analysed
    52
    52
    52
    49
    Units: Percentage
        least squares mean (standard error)
    -0.29 ( 0.051 )
    -0.29 ( 0.051 )
    -0.33 ( 0.053 )
    -0.1 ( 0.051 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in 7-Point Glucose Profile (Mean Daily Blood Glucose)

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    End point title
    		 Change from Baseline in 7-Point Glucose Profile (Mean Daily Blood Glucose)
    End point description
    Least squares (LS) means and standard errors at Week 17 were obtained from a mixed effect model with repeated measures (MMRM). FAS population.
    End point type
    Secondary
    End point timeframe
    Visit 14 (Week 17)
    End point values
    		 HM11260C (8 mg) HM11260C (12 mg) HM11260C (16 mg) Placebo
    Number of subjects analysed
    52
    52
    52
    49
    Units: mmol/L
        least squares mean (standard error)
    -1.071 ( 0.268 )
    -1.295 ( 0.269 )
    -1.363 ( 0.267 )
    -0.311 ( 0.255 )
    No statistical analyses for this end point

    Secondary: Change from Serum Lipid Profile (Parameters LDL-C- HDL-C, TG)

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    End point title
    		 Change from Serum Lipid Profile (Parameters LDL-C- HDL-C, TG)
    End point description
    Least squares (LS) means and standard errors at Week 17 were obtained from a mixed effect model with repeated measures (MMRM). FAS population.
    End point type
    Secondary
    End point timeframe
    Week 17
    End point values
    		 HM11260C (8 mg) HM11260C (12 mg) HM11260C (16 mg) Placebo
    Number of subjects analysed
    52
    52
    52
    49
    Units: mmol/L
    least squares mean (standard error)
        Parameter LDL-C
    0.12 ( 0.106 )
    0 ( 0.107 )
    0.01 ( 0.109 )
    0.3 ( 0.102 )
        Parameter HDL-C
    0.03 ( 0.022 )
    0.02 ( 0.022 )
    -0.02 ( 0.023 )
    0.04 ( 0.022 )
        Parameter TG
    -0.441 ( 0.116 )
    -0.251 ( 0.108 )
    -0.086 ( 0.112 )
    -0.309 ( 0.11 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected beginning at screening and continuing through the final patient visit. SAEs, regardless of suspected causality, were recorded until at least 30 days after the subject had stopped study participation.
    Adverse event reporting additional description
    Reported AEs were TEAEs that had a start date on or after the first dose of IP or, if the start date was before the date of the first dose of IP, increased in severity on or after the date of the first dose of IP. Treatment-emergent SAEs and TEAEs were reported for the Safety Set, consisting of all participants who received any study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    HM11260C (8mg)
    Reporting group description
    		 Subjects received HM11260C as a subcutaneous injection in the abdomen via a pre-filled syringe. HM11260C 4mg was administered once a week for 4 weeks, HM11260C 8mg once a week for 1 week, and HM11260C 8mg once a month (every 28 days) thereafter.

    Reporting group title
    HM11260C (12mg)
    Reporting group description
    		 Subjects received HM11260C as a subcutaneous injection in the abdomen via a pre-filled syringe. HM11260C 4mg was administered once a week for 4 weeks, HM11260C 8mg once a week for 1 week, and HM11260C 12mg once a month (every 28 days) thereafter.

    Reporting group title
    HM11260C (16mg)
    Reporting group description
    		 Subjects received HM11260C as a subcutaneous injection in the abdomen via a pre-filled syringe. HM11260C 4mg was administered once a week for 4 weeks, HM11260C 8mg once a week for 1 week, and HM11260C 16mg once a month (every 28 days) thereafter.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo as a subcutaneous injection in the abdomen via a pre-filled syringe. Placebo was administered once a week for 5 weeks, and once a month (every 28 days) thereafter.

    Serious adverse events
    		 HM11260C (8mg) HM11260C (12mg) HM11260C (16mg) Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 52 (0.00%)
    5 / 52 (9.62%)
    3 / 53 (5.66%)
    2 / 50 (4.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon cancer stage II
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Rib fracture
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 53 (1.89%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal spasm
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 53 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 HM11260C (8mg) HM11260C (12mg) HM11260C (16mg) Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 52 (82.69%)
    43 / 52 (82.69%)
    42 / 53 (79.25%)
    32 / 50 (64.00%)
    Investigations
    Lipase increased
         subjects affected / exposed
    7 / 52 (13.46%)
    1 / 52 (1.92%)
    5 / 53 (9.43%)
    3 / 50 (6.00%)
         occurrences all number
    10
    3
    5
    3
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 52 (3.85%)
    3 / 52 (5.77%)
    0 / 53 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    2
    3
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 52 (13.46%)
    3 / 52 (5.77%)
    7 / 53 (13.21%)
    5 / 50 (10.00%)
         occurrences all number
    7
    4
    9
    5
    Dizziness
         subjects affected / exposed
    5 / 52 (9.62%)
    6 / 52 (11.54%)
    4 / 53 (7.55%)
    1 / 50 (2.00%)
         occurrences all number
    6
    8
    4
    1
    Blood and lymphatic system disorders
    Anaemia
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 52 (1.92%)
    3 / 52 (5.77%)
    0 / 53 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    3
    0
    0
    General disorders and administration site conditions
    Injection site bruising
         subjects affected / exposed
    3 / 52 (5.77%)
    1 / 52 (1.92%)
    0 / 53 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    3
    1
    0
    1
    Pain
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    3 / 53 (5.66%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    3
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    14 / 52 (26.92%)
    24 / 52 (46.15%)
    23 / 53 (43.40%)
    1 / 50 (2.00%)
         occurrences all number
    21
    37
    33
    2
    Vomiting
         subjects affected / exposed
    8 / 52 (15.38%)
    13 / 52 (25.00%)
    17 / 53 (32.08%)
    2 / 50 (4.00%)
         occurrences all number
    12
    19
    26
    2
    Diarrhoea
         subjects affected / exposed
    9 / 52 (17.31%)
    8 / 52 (15.38%)
    11 / 53 (20.75%)
    4 / 50 (8.00%)
         occurrences all number
    16
    11
    12
    4
    Gastrooesophageal reflux disease
         subjects affected / exposed
    7 / 52 (13.46%)
    3 / 52 (5.77%)
    4 / 53 (7.55%)
    0 / 50 (0.00%)
         occurrences all number
    7
    3
    6
    0
    Abdominal distension
         subjects affected / exposed
    3 / 52 (5.77%)
    5 / 52 (9.62%)
    0 / 53 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    3
    5
    0
    0
    Dyspepsia
         subjects affected / exposed
    4 / 52 (7.69%)
    2 / 52 (3.85%)
    1 / 53 (1.89%)
    0 / 50 (0.00%)
         occurrences all number
    4
    3
    1
    0
    Abdominal pain
         subjects affected / exposed
    1 / 52 (1.92%)
    3 / 52 (5.77%)
    2 / 53 (3.77%)
    0 / 50 (0.00%)
         occurrences all number
    1
    4
    2
    0
    Abdominal pain upper
         subjects affected / exposed
    2 / 52 (3.85%)
    3 / 52 (5.77%)
    0 / 53 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    2
    4
    0
    2
    Abdominal tenderness
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    3 / 53 (5.66%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Constipation
         subjects affected / exposed
    2 / 52 (3.85%)
    6 / 52 (11.54%)
    3 / 53 (5.66%)
    1 / 50 (2.00%)
         occurrences all number
    2
    9
    4
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 52 (1.92%)
    3 / 53 (5.66%)
    0 / 50 (0.00%)
         occurrences all number
    1
    1
    5
    0
    Pain in extremity
         subjects affected / exposed
    0 / 52 (0.00%)
    3 / 52 (5.77%)
    0 / 53 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    3
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 52 (7.69%)
    2 / 52 (3.85%)
    4 / 53 (7.55%)
    5 / 50 (10.00%)
         occurrences all number
    4
    2
    4
    5
    Urinary tract infection
         subjects affected / exposed
    4 / 52 (7.69%)
    4 / 52 (7.69%)
    1 / 53 (1.89%)
    2 / 50 (4.00%)
         occurrences all number
    4
    7
    1
    3
    Rhinitis
         subjects affected / exposed
    1 / 52 (1.92%)
    3 / 52 (5.77%)
    0 / 53 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    9 / 52 (17.31%)
    10 / 52 (19.23%)
    6 / 53 (11.32%)
    1 / 50 (2.00%)
         occurrences all number
    9
    11
    8
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Apr 2014
    Version 2.0 Global (except Germany) protocol amendment developed from and replacing protocol Version 01: Contraception inclusion criteria were updated and study procedures were modified.
    18 Jun 2014
    Version 3.0 Global (except Germany) protocol amendment developed from and replacing protocol Version 2.0 to change when to conduct the interim analysis.
    05 Nov 2014
    Version 4.0 Global (except Germany) protocol amendment developed from and replacing protocol Version 3.0 to change the interim analysis from a futility analysis to an analysis conducted for administrative purposes.
    12 Dec 2014
    Version 5.0 Global (except Germany) protocol amendment developed from and replacing protocol Version 4.0 to remove the glucagon assessments and analyses from the study as the glucagon assay performed during the study up to that time was not sensitive enough and did not give results within the normal range for glucagon.

    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.
    Per protocol amendment #5 (v.4.0, 12-Dec-2014) glucagon assessments were removed as the assay was not sensitive enough and did not give results within the normal range for glucagon.
    For support, Contact us.
    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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