Trials / Terminated
TerminatedNCT03713684
Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)
A 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 Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 370 (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 basal insulin alone or in combination with oral antidiabetic drugs (OADs). 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 64 weeks including an up to 2-week Screening Period, a 30-week Core Treatment Period, a 26-week Safety Extension 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 | Lantus (Insulin Glargine), SC, once daily; OADs, administered as per investigator prescription and in accordance with local labeling. |
Timeline
- Start date
- 2018-11-09
- Primary completion
- 2020-11-20
- Completion
- 2021-01-04
- First posted
- 2018-10-22
- Last updated
- 2021-12-02
- Results posted
- 2021-12-02
Locations
47 sites across 3 countries: United States, China, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03713684. Inclusion in this directory is not an endorsement.