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)
Phase 3
Terminated
NCT03713684
| Condition | Type 2 Diabetes Mellitus |
|---|
| Phase | Phase 3 |
|---|
| Sponsor | Sanofi |
|---|
| Status | Terminated |
|---|
| Enrollment | 370 participants |
|---|
| Interventions | Efpeglenatide SAR439977, Background therapy |
|---|
| Start date | Nov 9, 2018 |
|---|
| Completion date | Nov 20, 2020 |
|---|
| Results posted | Dec 2, 2021 |
|---|
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.
Change From Baseline to Week 30 in HbA1c
Baseline to Week 30 · percentage of HbA1c
| Placebo | -0.33 ± 1.09 percentage of HbA1c |
|---|
| Efpeglenatide 2 mg | -1.27 ± 0.95 percentage of HbA1c |
|---|
| Efpeglenatide 4 mg | -1.24 ± 0.96 percentage of HbA1c |
|---|
| Efpeglenatide 6 mg | -1.43 ± 0.94 percentage of HbA1c |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.