Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM

NCT02058147 · Completed

Last updated 2026-05-28

This clinical trial tested a combination of two diabetes medications (insulin glargine and lixisenatide) against each medication alone, all added to metformin, in adults with type 2 diabetes to see how well they lowered blood sugar over 30 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 1,170 people

Who can join Ages 18+ · all sexes

Timeline Started 2014-02 · est. completion 2015-06

Where 273 sites · Australia, Belgium, Canada, Chile, Czechia, Denmark, Estonia, France, Germany, Hungary, Italy, Latvia, Lithuania, Mexico, Poland, Romania, Russia, South Africa, Spain, Sweden, Ukraine, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT02058147 ↗

Description as written by the study sponsor.

Primary Objective: To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone and to insulin glargine alone (on top of metformin treatment) in glycated hemoglobin (HbA1c) change from baseline to Week 30. Secondary Objective: To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine alone and to lixisenatide alone (on top of metformin treatment) over a 30 week treatment period in participants with type 2 diabetes.

Treatments tested

Insulin glargine/lixisenatide Fixed Ratio Combination also known as (HOE901/AVE0010) Drug

Insulin glargine/Lixisenatide FRC was self-administered by subcutaneous (SC) injection in the morning within one hour before breakfast using one of the 2 prefilled disposable SoloStar® pen-injectors: Pen A containing 100 U/mL insulin glargine (Lantus, 100 U/mL) and 50 mcg/mL lixisenatide in a ratio of 2 U:1 mcg, used for administration of doses from 10 U to 40 U (10 U/5mcg to 40 U/20mcg). Pen B containing 100 U/mL insulin glargine (Lantus, 100 U/mL) and 33 mcg/mL lixisenatide in a ratio of 3 U:1 mcg, used to administer doses from 41 U to 60 U (41 U/13 mcg to 60 U/20 mcg). The starting dose was 10 U/5 mcg. Dose was then adjusted individually to reach and maintain fasting self-monitored plasma glucose (SMPG) of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L) while avoiding hypoglycemia.
Insulin glargine (HOE901) also known as Lantus Drug

Insulin glargine (100 U/mL) was self-administered by SC injection at approximately the same time every day. Dose was adjusted individually to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L) while avoiding hypoglycemia.
Lixisenatide (AVE0010) also known as Lyxumia Drug

Lixisenatide was self-administered by SC injection within 0 to 60 minutes before breakfast or evening meal. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
Metformin Drug

Pharmaceutical form: Tablet; Route of administration: Oral administration.

Main thing measured	Change in HbA1c From Baseline to Week 30
Sponsor	Sanofi
Conditions studied	Type 2 Diabetes
GLP-1 drugs	lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02058147 ↗