Trials / Terminated
TerminatedNCT03770728
Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea
A 30-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 Metformin Alone or in Combination With Sulfonylurea
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 312 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 type 2 diabetes mellitus (T2DM) inadequately controlled with metformin alone or in combination with sulfonylurea (SU). Secondary Objectives: * To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo on glycemic control. * To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo on body weight. * To evaluate the safety of once weekly injection of efpeglenatide.
Detailed description
Study duration per participant was approximately 39 weeks including an up to 3-week Screening Period, a 30-week Treatment Period, and a 6-week safety Follow-up Period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Efpeglenatide SAR439977 | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
| DRUG | Placebo | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
| DRUG | Background therapy: Metformin alone or in combination with SU | Pharmaceutical form: tablet Route of administration: oral, administered as per investigator and in accordance with local labeling. |
Timeline
- Start date
- 2019-08-01
- Primary completion
- 2020-11-28
- Completion
- 2020-12-27
- First posted
- 2018-12-10
- Last updated
- 2021-12-02
- Results posted
- 2021-12-02
Locations
48 sites across 3 countries: United States, China, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03770728. Inclusion in this directory is not an endorsement.