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NCT03770728 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea

A Phase 3 study, sponsored by Sanofi.

Terminated
Registry status
Phase 3
Development phase
312
Enrollment target

NCT03770728 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 312 participants.

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The verdict

NCT03770728, a Phase 3 study, was terminated before completion, sponsored by Sanofi.

TERMINATED
Registry status
Phase 3
Development phase
312 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 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.

Interventions

  • DRUG Placebo
  • DRUG Efpeglenatide SAR439977
  • DRUG Background therapy: Metformin alone or in combination with SU

Trial Details

FieldValue
Enrollment Target 312 participants
Start Date 2019-08-01
Est. Completion 2020-12-27
Phase Phase 3

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT03770728

The ClinicalTrials.gov registry entry for NCT03770728 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 312 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.

NCT03770728 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03770728 about?

NCT03770728 is a clinical study titled "Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea". 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). Sec...

What is the current status of trial NCT03770728?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 312 participants. The study started on 2019-08-01. Estimated completion is 2020-12-27.

What interventions are being tested in trial NCT03770728?

The interventions under investigation include: Placebo (DRUG), Efpeglenatide SAR439977 (DRUG), Background therapy: Metformin alone or in combination with SU (DRUG).

Who is sponsoring clinical trial NCT03770728?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.