drugset / Trial / NCT03770728
Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2019-08-01
- Primary completion
- 2020-11-28
- Completion
- 2020-12-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efpeglenatide | Peptide | 2 mg | Subcutaneous |
| Subject | Efpeglenatide | Peptide | 4 mg | Subcutaneous |
| Subject | Efpeglenatide | Peptide | 6 mg | Subcutaneous |
| Background | Metformin | Small molecule | — | Oral |