Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period

NCT02787551 · Completed

Last updated 2026-05-28

This clinical trial tested a combination of two diabetes medications (insulin glargine and lixisenatide) against a GLP-1 receptor agonist in adults with type 2 diabetes to see how well it lowered blood sugar over 26 weeks.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 514 people

Who can join Ages 18+ · all sexes

Timeline Started 2016-07 · est. completion 2018-11

Where 124 sites · Canada, Estonia, Germany, Israel, Italy, Romania, Slovakia, Spain, United States

What this study is testing ClinicalTrials.gov NCT02787551 ↗

Description as written by the study sponsor.

Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change. Secondary Objectives: To compare the overall efficacy and safety of the insulin glargine/lixisenatide FRC to GLP-1 RA on top of metformin (with or without pioglitazone, with or without sodium-glucose co-transporter 2 \[SGLT2\] inhibitor) in participants with type 2 diabetes. To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension period.

Treatments tested

Insulin glargine/lixisenatide fixed ratio combination also known as HOE901/AVE0010, Soliqua Drug

Pharmaceutical form: solution for injection Route of administration: subcutaneous
liraglutide also known as Victoza Drug

Pharmaceutical form: solution for injection Route of administration: subcutaneous
exenatide also known as Byetta Drug

Pharmaceutical form: solution for injection Route of administration: subcutaneous
exenatide extended-release also known as Bydureon Drug

Pharmaceutical form: solution for injection Route of administration: subcutaneous
albiglutide also known as Tanzeum Drug

Pharmaceutical form: solution for injection Route of administration: subcutaneous
dulaglutide also known as Trulicity Drug

Pharmaceutical form: solution for injection Route of administration: subcutaneous
Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor) Drug

Pharmaceutical form: tablet Route of administration: oral If previously taken, doses to remain stable through the study.

Main thing measured	Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period
Sponsor	Sanofi
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02787551 ↗