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NCT03713684 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 370
- Enrollment target
NCT03713684 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 370 participants.
The verdict
NCT03713684, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 370 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Background therapy
- DRUG Efpeglenatide SAR439977
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 370 participants |
| Start Date | 2018-11-09 |
| Est. Completion | 2021-01-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03713684
The ClinicalTrials.gov registry entry for NCT03713684 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 370 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03713684 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03713684 about?
NCT03713684 is a clinical study titled "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)". 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 d...
What is the current status of trial NCT03713684?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 370 participants. The study started on 2018-11-09. Estimated completion is 2021-01-04.
What interventions are being tested in trial NCT03713684?
The interventions under investigation include: Placebo (DRUG), Background therapy (DRUG), Efpeglenatide SAR439977 (DRUG).
Who is sponsoring clinical trial NCT03713684?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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