Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes

NCT02058160 · Completed

Last updated 2026-05-28

This clinical trial tested a combination of two diabetes medications (insulin glargine and lixisenatide) against insulin glargine alone in adults with type 2 diabetes to see how it affects blood sugar control 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 736 people

Who can join Ages 18+ · all sexes

Timeline Started 2014-01 · est. completion 2015-07

Where 236 sites · Australia, Canada, Chile, Czechia, Denmark, Estonia, Hungary, Lithuania, Mexico, Netherlands, Poland, Romania, Russia, Slovakia, Spain, Sweden, Ukraine, United States

What this study is testing ClinicalTrials.gov NCT02058160 ↗

Description as written by the study sponsor.

Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 30. Secondary Objective: To compare the overall efficacy and safety of insulin glargine/lixisenatide FRC to insulin glargine (with or without metformin) over a 30 week treatment period in participants with type 2 diabetes.

Treatments tested

Insulin glargine/lixisenatide (HOE901/AVE0010) Drug

Insulin glargine/lixisenatide FRC was self-administered by subcutaneous (SC) injection within 1 hour before breakfast using one of 2 SoloStar® pen-injectors: Pen A (ratio of 2 Units (U) of insulin glargine U 100:1 mcg of lixisenatide) or Pen B (ratio of 3 U of insulin glargine U 100:1 mcg of lixisenatide). After run-in, the FRC was initiated at a dose of either 20 U/10 mcg with Pen A or 30 U/10 mcg with Pen B, depending on participant's dose of Insulin glargine on the day prior to randomization. Dose was adjusted weekly 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). Pen A was used for administration of doses up to 40 U/20 mcg and Pen B for administration of doses from 30 U/10 mcg up to 60 U/20 mcg.
Insulin glargine (HOE901) also known as Lantus Drug

Insulin glargine was self-administered QD by SC injection at approximately the same time every day. After screening, eligible participants entered 6 week run-in phase during which they were switched (if necessary) to insulin glargine and dose was stabilized. The first dose after randomization was same as the one administered on the day prior to randomization and then dose was adjusted weekly to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L).
Metformin (Background Drug) Drug

Pharmaceutical form: Tablet; Route of administration: Oral administration

Main thing measured	Change in Glycated Hemoglobin (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 NCT02058160 ↗