A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus

NCT02973321 · Completed

Last updated 2026-05-28

This clinical trial tested the safety and effectiveness of the medication SAR425899 in adults with type 2 diabetes to see how it affects their blood sugar levels over 26 weeks.

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 296 people

Who can join Ages 18–80 · all sexes

Timeline Started 2016-12 · est. completion 2017-12

Where 59 sites · Canada, Czechia, Germany, Hungary, Mexico, Russia, Spain, United States

What this study is testing ClinicalTrials.gov NCT02973321 ↗

Description as written by the study sponsor.

Primary Objective: The primary objective of this study was to assess the dose-response relationship of SAR425899 versus placebo in terms of glycemic control as measured by the change in glycosylated hemoglobin (HbA1c). Secondary Objectives: * To assess the effect of SAR425899 on body weight. * To assess the safety and immunogenicity profile of SAR425899, including assessment of the heart rate (HR) change by electrocardiogram (ECG) and Holter monitor. * To assess the proportion of participants achieving predefined HbA1c targets of \<7% and \<6.5% as well as the proportion of participants achieving \>=5% and \>=10% body weight loss. * To assess the effect of once daily dosing of SAR425899 on additional parameters of glycemic control and lipid metabolism. * To assess the effect of once daily dosing of SAR425899 on additional pharmacodynamic (PD) biomarkers. * To assess the pharmacokinetic (PK) profile and parameters of SAR425899, inter-individual and inter-occasion variability in PK parameters using a population PK approach.

Treatments tested

SAR425899 Drug

Self-administered by SC injection using a solution for injection in cartridge.
Placebo Drug

Self-administered by SC injection using a solution for injection in cartridge.
Liraglutide also known as Victoza Drug

Self-administered by SC injection using a pre-filled pen.
Metformin Drug

Orally administered at a stable dose , \>=1500 mg daily stable dose or maximal tolerated dose.

Main thing measured	Change From Baseline in HbA1c to Week 26
Sponsor	Sanofi
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02973321 ↗