drugset
drugset / Trial / NCT03713684

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)

NCT03713684 ↗

Phase 3 Terminated 370 enrolled Sanofi Hanmi Pharmaceutical Company Limited · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2018-11-09
Primary completion
2020-11-20
Completion
2021-01-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Efpeglenatide Peptide 2 mg Subcutaneous
Subject Efpeglenatide Peptide 4 mg Subcutaneous
Subject Efpeglenatide Peptide 6 mg Subcutaneous
Background insulin glargine Protein / enzyme biologic — Subcutaneous

Indications

type 2 diabetes mellitus