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    Clinical Trial Results:
    A 56-week, Multicenter, Open-label, Active-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly Compared to Dulaglutide Once Weekly in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin

    Summary
    EudraCT number
    		 2017-002956-10
    Trial protocol
    		 PL   HU  
    Global end of trial date
    17 Nov 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Nov 2021
    First version publication date
    14 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EFC14829
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03684642
    WHO universal trial number (UTN)
    		 U1111-1205-3150
    Sponsors
    Sponsor organisation name
    Sanofi-aventis Recherche & Développement
    Sponsor organisation address
    1, Avenue Pierre Brossolette, Chilly Mazarin, France, 91385
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.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
    21 Jan 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Nov 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To demonstrate the noninferiority of once weekly injection of efpeglenatide 4 or 6 milligrams (mg) in comparison to once weekly injection of dulaglutide 1.5 mg on glycated hemoglobin (HbA1c) change from Baseline to Week 56 in subjects with Type 2 diabetes mellitus (T2DM) inadequately controlled with 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 the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    		 Metformin oral tablet administered as per the Investigator’s prescription. Dose was kept stable throughout the study.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Sep 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 166
    Country: Number of subjects enrolled
    Hungary: 112
    Country: Number of subjects enrolled
    United States: 498
    Country: Number of subjects enrolled
    Ukraine: 132
    Worldwide total number of subjects
    908
    EEA total number of subjects
    278
    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)
    567
    From 65 to 84 years
    340
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 45 active sites in 4 countries. A total of 1608 subjects were screened between 26 September 2018 and 17 December 2019, out of which 700 were screen failures. Screen failures were mainly due to inclusion criteria not met.

    Pre-assignment
    Screening details
    		 A total of 908 subjects were randomized in 1:1:1 ratio to either efpeglenatide 4 mg, efpeglenatide 6 mg, or dulaglutide 1.5 mg treatment arms, stratified by screening HbA1c values (less than [<]8%, greater than or equal to [>=]8 percent [%]) and by body mass index (BMI) (<30 kilogram per meter square [kg/m^2] and >=30 kg/m^2) on Day 1.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Efpeglenatide 4 mg
    Arm description
    		 Subjects received Efpeglenatide subcutaneous (SC) injection once weekly up to Week 56 on top of metformin. Subjects initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Efpeglenatide
    Investigational medicinal product code
    SAR439977
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Efpeglenatide SC injection once weekly on top of metformin.

    Arm title
    		 Efpeglenatide 6 mg
    Arm description
    		 Subjects received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Subjects initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Efpeglenatide
    Investigational medicinal product code
    SAR439977
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Efpeglenatide SC injection once weekly on top of metformin.

    Arm title
    		 Dulaglutide 1.5 mg
    Arm description
    		 Subjects received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Subjects initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dulaglutide
    Investigational medicinal product code
    Other name
    Trulicity™
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dulaglutide SC injection once weekly on top of metformin.

    Number of subjects in period 1
    		Efpeglenatide 4 mg Efpeglenatide 6 mg Dulaglutide 1.5 mg
    Started
    303
    302
    303
    Treated
    303
    302
    302
    Completed
    200
    169
    197
    Not completed
    103
    133
    106
         Adverse Event
    6
    15
    11
         Randomized and not treated
    -
    -
    1
         Withdrawal by Subject
    35
    53
    23
         Other than specified
    62
    60
    67
         Poor compliance to protocol
    -
    4
    1
         Missing completion status but aliveat last contact
    -
    1
    2
         Lack of efficacy
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Efpeglenatide 4 mg
    Reporting group description
    		 Subjects received Efpeglenatide subcutaneous (SC) injection once weekly up to Week 56 on top of metformin. Subjects initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.

    Reporting group title
    Efpeglenatide 6 mg
    Reporting group description
    		 Subjects received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Subjects initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.

    Reporting group title
    Dulaglutide 1.5 mg
    Reporting group description
    		 Subjects received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Subjects initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.

    Reporting group values
    		 Efpeglenatide 4 mg Efpeglenatide 6 mg Dulaglutide 1.5 mg Total
    Number of subjects
    		 303 302 303 908
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.3 ± 9.6 60.0 ± 10.1 59.4 ± 10.1 -
    Gender categorical
    Units: Subjects
        Female
    		 142 157 153 452
        Male
    		 161 145 150 456
    Race/Ethnicity
    Units: Subjects
        White
    		 271 263 275 809
        Black or African American
    		 24 30 18 72
        Asian
    		 5 3 6 14
        Other
    		 3 4 2 9
        Not reported
    		 0 2 2 4
    Body Mass Index (BMI)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 33.4 ± 6.1 33.4 ± 6.2 33.4 ± 6.4 -
    Baseline Glycated Hemoglobin (HbA1c %)
    Units: percentage of HbA1c
        arithmetic mean (standard deviation)
    		 8.12 ± 0.82 8.07 ± 0.78 8.11 ± 0.81 -

    End points

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    End points reporting groups
    Reporting group title
    Efpeglenatide 4 mg
    Reporting group description
    		 Subjects received Efpeglenatide subcutaneous (SC) injection once weekly up to Week 56 on top of metformin. Subjects initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.

    Reporting group title
    Efpeglenatide 6 mg
    Reporting group description
    		 Subjects received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Subjects initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.

    Reporting group title
    Dulaglutide 1.5 mg
    Reporting group description
    		 Subjects received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Subjects initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.

    Subject analysis set title
    Efpeglenatide 4 mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Subjects initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.

    Primary: Change From Baseline to Week 56 in HbA1c

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    End point title
    		 Change From Baseline to Week 56 in HbA1c
    End point description
    Adjusted Least square (LS) means and Standard errors (SE) were obtained from analysis of covariance (ANCOVA) model to account for missing data. Missing values were imputed by baseline observation carried forward (BOCF)-like multiple imputation method. Analysis was performed on modified intent-to-treat (mITT) population which included subjects who completed study treatment; or who discontinued study treatment and completed/discontinued study before early termination; or who discontinued treatment before early termination and discontinued study due to early termination; or who discontinued treatment due to early termination within 30 days of target Week 56 visit.
    End point type
    Primary
    End point timeframe
    Baseline to Week 56
    End point values
    		 Efpeglenatide 4 mg Efpeglenatide 6 mg Dulaglutide 1.5 mg
    Number of subjects analysed
    257
    254
    250
    Units: percentage of HbA1c
        least squares mean (standard error)
    -1.12 ± 0.06
    -1.17 ± 0.06
    -1.09 ± 0.06
    Statistical analysis title
    		 Efpeglenatide 4 mg versus Dulaglutide 1.5 mg
    Statistical analysis description
    A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using ANCOVA model with the treatment groups, randomisation strata, and geographical region as fixed classification effects, and Baseline HbA1c value as a continuous covariate.
    Comparison groups
    Efpeglenatide 4 mg v Dulaglutide 1.5 mg
    Number of subjects included in analysis
    507
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 LS Mean difference
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.09
    Notes
    [1] - Non-inferiority of Efpeglenatide vs. Dulaglutide was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was <=0.3%.
    Statistical analysis title
    		 Efpeglenatide 6 mg versus Dulaglutide 1.5 mg
    Statistical analysis description
    A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using ANCOVA model with the treatment groups, randomisation strata, and geographical region as fixed classification effects, and Baseline HbA1c value as a continuous covariate.
    Comparison groups
    Efpeglenatide 6 mg v Dulaglutide 1.5 mg
    Number of subjects included in analysis
    504
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.25
         upper limit
    		 0.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.09
    Notes
    [2] - Non-inferiority of Efpeglenatide vs. Dulaglutide was demonstrated if the upper bound of the two-sided 95% CI for the difference between groups was <=0.3%.
    Statistical analysis title
    		 Efpeglenatide 4 mg versus Dulaglutide 1.5 mg
    Comparison groups
    Efpeglenatide 4 mg v Dulaglutide 1.5 mg
    Number of subjects included in analysis
    507
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7064 [3]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [3] - Threshold for significance at the level of 0.05.
    Statistical analysis title
    		 Efpeglenatide 6 mg versus Dulaglutide 1.5 mg
    Comparison groups
    Efpeglenatide 6 mg v Dulaglutide 1.5 mg
    Number of subjects included in analysis
    504
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3427 [4]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [4] - Threshold for significance at the level of 0.05.

    Secondary: Change From Baseline to Week 56 in Body Weight

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    End point title
    		 Change From Baseline to Week 56 in Body Weight
    End point description
    Adjusted LS means and SE were obtained from ANCOVA model to account for missing data. Missing values were imputed by BOCF-like multiple imputation method. Analysis was performed on mITT population.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 56
    End point values
    		 Efpeglenatide 4 mg Efpeglenatide 6 mg Dulaglutide 1.5 mg
    Number of subjects analysed
    257
    254
    250
    Units: kilogram
        least squares mean (standard error)
    -2.87 ± 0.64
    -3.04 ± 0.67
    -2.81 ± 0.66
    No statistical analyses for this end point

    Secondary: Number of Subjects With HbA1c <7.0%

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    End point title
    		 Number of Subjects With HbA1c <7.0%
    End point description
    Subjects who had no available assessment for HbA1c at Week 56 were considered as non-responders. Analysis was performed on mITT population.
    End point type
    Secondary
    End point timeframe
    Week 56
    End point values
    		 Efpeglenatide 4 mg Efpeglenatide 6 mg Dulaglutide 1.5 mg
    Number of subjects analysed
    257
    254
    250
    Units: subjects
    155
    157
    150
    No statistical analyses for this end point

    Secondary: Change From Baseline to Week 56 in Fasting Plasma Glucose (FPG)

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    End point title
    		 Change From Baseline to Week 56 in Fasting Plasma Glucose (FPG)
    End point description
    Adjusted LS means and SE were obtained from ANCOVA model to account for missing data. Missing values were imputed by BOCF-like multiple imputation method. Analysis was performed on mITT population.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 56
    End point values
    		 Efpeglenatide 4 mg Efpeglenatide 6 mg Dulaglutide 1.5 mg
    Number of subjects analysed
    257
    254
    250
    Units: millimoles per liter (mmol/L)
        least squares mean (standard error)
    -1.81 ± 0.15
    -1.57 ± 0.15
    -1.71 ± 0.15
    No statistical analyses for this end point

    Secondary: Number of Subjects With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/ L [<54 mg/dL], Severe Hypoglycemia)

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    End point title
    		 Number of Subjects With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/ L [<54 mg/dL], Severe Hypoglycemia) [5]
    End point description
    Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <3.0 mmol/L (54 milligrams per deciliter [mg/dL]). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Analysis was performed on safety population which included subjects who received at least 1 dose or part of a dose of the Investigational Medicinal Product (IMP), analyzed according to the treatment actually received. 10 subjects randomised to Efpeglenatide 6 mg received 4 mg dose for longer duration, and considered in the Efpeglenatide 4 mg group for safety analysis.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 56
    Notes
    [5] - 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: Data was reported for the arms applicable for the endpoint.
    End point values
    		 Efpeglenatide 6 mg Dulaglutide 1.5 mg Efpeglenatide 4 mg
    Number of subjects analysed
    292
    302
    313
    Units: subjects
        Documented symptomatic hypoglycemia (<54 mg/dL)
    1
    0
    3
        Severe hypoglycemia
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Subject-Year

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    End point title
    		 Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Subject-Year [6]
    End point description
    Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <3.0 mmol/L (<54 mg/dL). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Analysis was performed on safety population. 10 subjects randomised to Efpeglenatide 6 mg received 4 mg dose for longer duration, and considered in the Efpeglenatide 4 mg group for safety analysis.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 56
    Notes
    [6] - 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: Data was reported for the arms applicable for the endpoint.
    End point values
    		 Efpeglenatide 6 mg Dulaglutide 1.5 mg Efpeglenatide 4 mg
    Number of subjects analysed
    292
    302
    313
    Units: events per subject-year
    number (not applicable)
        Documented symptomatic hypoglycemia (<54 mg/dL)
    0.01
    0
    0.01
        Severe hypoglycemia
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) were collected from signature of informed consent up to end of study. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 30 days after last injection of the IMP (Week 60).
    Adverse event reporting additional description
    TEAEs were defined as AEs that developed or worsened during the treatment-emergent period. Analysis was performed on safety population. For safety analysis, subjects were included in the treatment group in which they were exposed for longer duration.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Efpeglenatide 4 mg
    Reporting group description
    		 Subjects received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Subjects initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration. Included 10 subjects randomized to Efpeglenatide 6 mg who received 4 mg for longer duration and considered in the Efpeglenatide 4 mg for safety analysis.

    Reporting group title
    Efpeglenatide 6 mg
    Reporting group description
    		 Subjects received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Subjects initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration. 10 subjects were excluded as they received 4 mg for longer duration and considered in the Efpeglenatide 4 mg group for safety analysis.

    Reporting group title
    Dulaglutide 1.5 mg
    Reporting group description
    		 Subjects received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Subjects initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.

    Serious adverse events
    		 Efpeglenatide 4 mg Efpeglenatide 6 mg Dulaglutide 1.5 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    20 / 313 (6.39%)
    23 / 292 (7.88%)
    20 / 302 (6.62%)
         number of deaths (all causes)
    0
    0
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign Salivary Gland Neoplasm
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 292 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon Cancer Metastatic
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 292 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant Melanoma
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 292 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningioma Benign
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 292 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Papillary Renal Cell Carcinoma
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 292 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Neoplasm
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 292 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal Meningioma Benign
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 292 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 292 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive Urgency
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 292 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral Arterial Occlusive Disease
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 292 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign Prostatic Hyperplasia
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 292 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 292 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 292 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 292 (0.00%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Mental Status Changes
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 292 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 292 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ligament Sprain
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 292 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular Graft Occlusion
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 292 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Myocardial Infarction
         subjects affected / exposed
    1 / 313 (0.32%)
    2 / 292 (0.68%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina Pectoris
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 292 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina Unstable
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 292 (0.34%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    1 / 313 (0.32%)
    1 / 292 (0.34%)
    2 / 302 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular Block Complete
         subjects affected / exposed
    0 / 313 (0.00%)
    2 / 292 (0.68%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 292 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Coronary Artery Disease
         subjects affected / exposed
    2 / 313 (0.64%)
    0 / 292 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial Ischaemia
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 292 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinus Node Dysfunction
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 292 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Supraventricular Tachycardia
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 292 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Carpal Tunnel Syndrome
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 292 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular Accident
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 292 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 292 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 292 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 292 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 292 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular Encephalopathy
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 292 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Iron Deficiency Anaemia
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 292 (0.34%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 292 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis Ulcerative
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 292 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum Intestinal Haemorrhagic
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 292 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 292 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 292 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Omental Necrosis
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 292 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 292 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis Chronic
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 292 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 292 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 313 (0.32%)
    2 / 292 (0.68%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    1 / 313 (0.32%)
    1 / 292 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic Kidney Disease
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 292 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 292 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcapsular Renal Haematoma
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 292 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 292 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Covid-19 Pneumonia
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 292 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis Infective
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 292 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 313 (0.32%)
    1 / 292 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia Urinary Tract Infection
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 292 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 292 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 313 (0.32%)
    1 / 292 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 292 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 292 (0.34%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sialoadenitis
         subjects affected / exposed
    0 / 313 (0.00%)
    0 / 292 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal Infection
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 292 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 292 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Efpeglenatide 4 mg Efpeglenatide 6 mg Dulaglutide 1.5 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    202 / 313 (64.54%)
    180 / 292 (61.64%)
    178 / 302 (58.94%)
    Investigations
    Lipase Increased
         subjects affected / exposed
    27 / 313 (8.63%)
    19 / 292 (6.51%)
    24 / 302 (7.95%)
         occurrences all number
    34
    22
    29
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    18 / 313 (5.75%)
    10 / 292 (3.42%)
    10 / 302 (3.31%)
         occurrences all number
    18
    15
    11
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    24 / 313 (7.67%)
    30 / 292 (10.27%)
    16 / 302 (5.30%)
         occurrences all number
    32
    39
    25
    Abdominal Pain Upper
         subjects affected / exposed
    22 / 313 (7.03%)
    16 / 292 (5.48%)
    18 / 302 (5.96%)
         occurrences all number
    22
    20
    18
    Constipation
         subjects affected / exposed
    32 / 313 (10.22%)
    34 / 292 (11.64%)
    19 / 302 (6.29%)
         occurrences all number
    33
    37
    21
    Diarrhoea
         subjects affected / exposed
    93 / 313 (29.71%)
    83 / 292 (28.42%)
    90 / 302 (29.80%)
         occurrences all number
    128
    120
    134
    Dyspepsia
         subjects affected / exposed
    26 / 313 (8.31%)
    17 / 292 (5.82%)
    15 / 302 (4.97%)
         occurrences all number
    30
    18
    20
    Nausea
         subjects affected / exposed
    85 / 313 (27.16%)
    83 / 292 (28.42%)
    78 / 302 (25.83%)
         occurrences all number
    116
    109
    111
    Vomiting
         subjects affected / exposed
    41 / 313 (13.10%)
    45 / 292 (15.41%)
    37 / 302 (12.25%)
         occurrences all number
    57
    65
    64
    Infections and infestations
    Upper Respiratory Tract Infection
         subjects affected / exposed
    21 / 313 (6.71%)
    18 / 292 (6.16%)
    20 / 302 (6.62%)
         occurrences all number
    24
    20
    22
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    38 / 313 (12.14%)
    50 / 292 (17.12%)
    36 / 302 (11.92%)
         occurrences all number
    39
    56
    40

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Jul 2019
    Following changes were made: Post-dose Pharmacokinetic (PK) sampling time changed from 4 days (±1 day) to 3 days (±1 day) in order to collect more PK data in the absorption phase. Sample collection time points (only in efpeglenatide treated subjects) had been clarified; sample collection time points had been specified to allow higher flexibility with regard to post-dose sample collection window in order to facilitate additional post-dose sampling. A preferred interval for PK post-dose sampling (between Week 8 and Week 12) was defined considering the balance between two requirements: PK steady state and limited risk of anti-drug antibodies (ADA) formation. The PK endpoint had been updated to remove the operational instruction language; clarified the general PK sampling process; clarified the site of administration; reflected the changes made in PK endpoint; clarified studied population; schedule of activities -footnote updated; clarified sampling requirements; clarified reference source of information; clarified definition of fasting for purpose of sample collection for glycemic parameters; clarification to include DTP, a new process regarding IMP dispensation in case of emergency; clarified measure to minimise bias: randomisation and blinding; clarified randomisation code breaking during the study; clarification for specific IMP return process for autoinjectors that functioned normally; schedule of assessments after permanent IMP discontinuation; clarified that review and reconciliation by the Investigators of subjects responses to PROMIS GI symptom scale was not needed; adverse event of diabetic retinopathy complications were reviewed as per current medical review process without an independent ophthalmologist expert review.

    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.
    Study was terminated early by Sponsor on 09 September 2020. Due to early termination of study, model-based efficacy analyses were performed in mITT population instead of the ITT population originally planned and data was carefully considered.
    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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