Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

ID: NCT03353350
Status: Recruiting
Phase: Phase 3
Start Date: December 05, 2017
First Submitted: November 21, 2017
Last Updated: February 22, 2018
Results: N/A
Organization: Sanofi
Sponsors & Collaborators: Sanofi
Location: United States
Conditions: Type 2 Diabetes Mellitus
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Study Description

Brief Summary

Primary Objective:

To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with T2DM (Type 2 Diabetes Mellitus) inadequately controlled with diet and exercise.

Secondary Objectives:

- To compare the effects of once weekly injection of efpeglenatide with placebo on glycemic control.

- To compare the effects of once weekly injection of efpeglenatide with placebo on body weight.

Detailed Description

Study duration per participant is approximately 65 weeks, including a 3-week screening period, 30 weeks core treatment period, 26 weeks extension treatment period, and 6 weeks safety follow up.
Condition or disease Intervention/treatment Phase

Type 2 Diabetes Mellitus

Drug: efpeglenatide (SAR439977)
Other Names
Drug: placebo
Other Names
Phase 3

Tracking Information

First Submitted DateNovember 21, 2017
Last Update Posted DateFebruary 22, 2018
Actual Start DateDecember 05, 2017
Anticipated Completion DateFebruary 28, 2020
Actual Primary Completion DateFebruary 28, 2020
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Change in glycated hemoglobin (HbA1c) (%) [Time Frame: Baseline to Week 30]

    Change from Baseline to Week 30 in HbA1c (%)

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Change in HbA1c (%) [Time Frame: Baseline to Week 56]

    Change from Baseline to Week 56 in HbA1c (%)

  • Change in fasting plasma glucose (FPG) [Time Frame: Baseline to Week 30, Week 56]

    Change from Baseline to Week 30 and to Week 56 in FPG

  • Change in 7-point self-monitored plasma glucose (SMPG) profile [Time Frame: Baseline to Week 30, Week 56]

    Change from Baseline to Week 30 and to Week 56 in 7-point SMPG profiles (24-hour profile, mean 24-hour SMPG, average pre breakfast SMPG, prandial glucose excursions)

  • HbA1c <7% [Time Frame: Week 30, Week 56]

    Percentage of patients with HbA1c <7.0% at Week 30 and Week 56

  • Rescue therapy [Time Frame: Week 30, Week 56]

    Number of participants rescue therapy until Weeks 30 and 56

  • Time to rescue therapy [Time Frame: Week 56]

    Time to initiation of rescue therapy

  • Change in body weight [Time Frame: Baseline to Week 30, Week 56]

    Change from Baseline to Week 30 and to Week 56 in body weight

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleEfficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
Official TitleA 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
Brief Summary

Primary Objective:

To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with T2DM (Type 2 Diabetes Mellitus) inadequately controlled with diet and exercise.

Secondary Objectives:

- To compare the effects of once weekly injection of efpeglenatide with placebo on glycemic control.

- To compare the effects of once weekly injection of efpeglenatide with placebo on body weight.

Detailed Description

Study duration per participant is approximately 65 weeks, including a 3-week screening period, 30 weeks core treatment period, 26 weeks extension treatment period, and 6 weeks safety follow up.

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
400
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
Primary Purpose
Treatment
Conditions
Type 2 Diabetes Mellitus
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: efpeglenatide (SAR439977)

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Other Names
Drug: placebo

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Other Names
Study Groups/Cohorts
Efpeglenatide low dose
Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks

Efpeglenatide middle dose
Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)

Efpeglenatide high dose
Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)

Placebo
Matching placebo (Prefilled syringe) administered once weekly for 56 weeks

Study Arms
Experimental Efpeglenatide high dose
Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)
Drug : efpeglenatide (SAR439977)
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Experimental Efpeglenatide low dose
Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks
Drug : efpeglenatide (SAR439977)
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Experimental Efpeglenatide middle dose
Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)
Drug : efpeglenatide (SAR439977)
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Placebo Comparator Placebo
Matching placebo (Prefilled syringe) administered once weekly for 56 weeks
Drug : placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Arm Intervention/Treatment
Experimental Efpeglenatide high dose
Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)
Drug : efpeglenatide (SAR439977)
Experimental Efpeglenatide low dose
Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks
Drug : efpeglenatide (SAR439977)
Experimental Efpeglenatide middle dose
Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)
Drug : efpeglenatide (SAR439977)
Placebo Comparator Placebo
Matching placebo (Prefilled syringe) administered once weekly for 56 weeks
Drug : placebo

Recruitment Information

Recruitment Status:Recruiting
Enrollment400
Completion DateFebruary 28, 2020
Eligibility Criteria: Inclusion criteria :
- Participants must be at least 18 years of age at the time of signing the informed consent.
- Participants with type 2 diabetes mellitus (T2DM), based on the World Health Organization (WHO) diagnosis guideline and treated with diet and exercise.
- Hemoglobin A1c between 7.0% and 10.0% (inclusive) measured by the central laboratory at Screening.
Exclusion criteria:
- Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis, unstable and not controlled gastroesophageal reflux disease within 6 months prior to Screening.
- History of chronic pancreatitis or acute idiopathic pancreatitis or diagnosis of any type of acute pancreatitis within 3 months prior to Screening.
- Personal or family history of Medullary Thyroidian Cancer (MTC) or genetic conditions that predisposes to MTC (eg multiple endocrine neoplasia syndromes).
- Proliferative retinopathy or maculopathy requiring treatment according to the Investigator.
- Body weight change of ≥5 kg within the last 3 months prior to Screening.
- Systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg at Randomization
- End-stage renal disease as defined by estimated glomerular filtration rate (eGFR , by Modification of Diet in Renal Disease (MDRD)) of <15 mL/min/1.73 m2.
- Laboratory findings at the Screening Visit:
- Alanine aminotransferase (ALT ) or aspartate aminotransferase (AST ) >3 times the upper limit of the normal (ULN ) or total bilirubin >1.5 times the ULN (except in case of documented Gilbert's syndrome).
- Hemoglobin <110 g/L (<11 g/dL) and/or neutrophils <1.5 x 109/L (<1500/mm3) (or according to the ethnic group) and/or platelets <100 x 109/L (<100 000/mm3).
- Amylase and/or lipase: >3 times the ULN laboratory range.
- Calcitonin ≥5.9 pmol/L (20 pg/mL).
- Gastric surgery or other gastric procedures intended for weight loss within 2 years prior to Screening, or planned during study period.
- History of drug or alcohol abuse within 6 months prior to the time of Screening.
- Pregnant (demonstrated by serum pregnancy test at Screening) or breast-feeding women.
- Women of childbearing potential not willing to use highly effective method(s) of birth control during the study.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03353350
Other Study ID Numbers
EFC14822
2016-001857-42
U1111-1182-1806
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Sanofi
Collaborators
Not Available
Investigators
Study Director
Clinical Sciences & Operations
Sanofi