drugset / Trial / NCT03684642
Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary Objective: To demonstrate the non-inferiority of once weekly injection of efpeglenatide in comparison to once weekly injection of dulaglutide on glycated hemoglobin (HbA1c) change in participants with Type 2 diabetes mellitus (T2DM) inadequately controlled with metformin. Secondary Objectives: * To demonstrate the superiority of once weekly injection of efpeglenatide with once weekly injection of dulaglutide on glycemic control. * To demonstrate the superiority of once weekly injection of efpeglenatide with once weekly injection of dulaglutide on body weight. * To evaluate the safety of once weekly injection of efpeglenatide and once weekly injection of dulaglutide.
Timeline
- Start
- 2018-09-26
- Primary completion
- 2020-10-13
- Completion
- 2020-11-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dulaglutide | Peptide | 1.5 mg | Subcutaneous |
| Subject | Efpeglenatide | Peptide | 4 mg | Subcutaneous |
| Subject | Efpeglenatide | Peptide | 6 mg | Subcutaneous |
| Background | Metformin | Small molecule | — | Oral |