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NCT03684642 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 908
- Enrollment target
NCT03684642: Clinical Trial Phase 3 study, sponsored by Sanofi.
NCT03684642 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 908 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03684642, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 908 participants
- Enrollment target
Study 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.
Primary Outcome
Adjusted Least square (LS) means and Standard errors (SE) were obtained from analysis of covariance (ANCOVA) model to account for missing data. Missing values were imputed by baseline observation carried forward (BOCF)-like multiple imputation method.
Interventions
- DRUG Dulaglutide
- DRUG Efpeglenatide
- DRUG Background therapy Metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 908 participants |
| Start Date | 2018-09-26 |
| Est. Completion | 2020-11-17 |
| Phase | Phase 3 |
Why NCT03684642 stopped before completion
NCT03684642 is an interventional study that assigns participants to a tested intervention. The registered 908 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% higher).
The record links to 0 conditions, and to 3 interventions - of which Dulaglutide is the first listed.
NCT03684642 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03684642 about?
NCT03684642 is a clinical study titled "Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin". 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 Objecti...
What is the current status of trial NCT03684642?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 908 participants. The study started on 2018-09-26. Estimated completion is 2020-11-17.
What interventions are being tested in trial NCT03684642?
The interventions under investigation include: Dulaglutide (DRUG), Efpeglenatide (DRUG), Background therapy Metformin (DRUG).
Who is sponsoring clinical trial NCT03684642?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03684642's enrollment target sits among peer trials
908 347th of 2000 higher than 1,654 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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