Postprandial Glucodynamic Response to Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus

NCT02713477 · Completed

Last updated 2026-05-28

This clinical trial tested how a combination of two diabetes medications affects blood sugar levels after meals in Japanese adults with type 2 diabetes.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

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

Participants 20 people

Who can join Ages 20–75 · all sexes

Timeline Started 2016-04 · est. completion 2016-06

Where 1 site · Japan

What this study is testing ClinicalTrials.gov NCT02713477 ↗

Description as written by the study sponsor.

Primary Objective: To assess the postprandial glucodynamic response to 2 doses of insulin glargine/lixisenatide fixed-ratio combination compared to placebo in Japanese patients with type 2 diabetes mellitus (T2DM). Secondary Objectives: * To assess the pharmacokinetics (PK) of lixisenatide following administration of 2 different doses of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM. * To assess the postprandial glucodynamic response to insulin glargine/lixisenatide fixed-ratio combination compared to insulin glargine alone in Japanese patients with T2DM. * To assess the safety and tolerability of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM.

Treatments tested

Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010 Drug

Pharmaceutical form: solution Route of administration: subcutaneous
Insulin glargine HOE901 also known as Lantus Drug

Pharmaceutical form: solution Route of administration: subcutaneous
Placebo Drug

Pharmaceutical form: solution Route of administration: subcutaneous

Main thing measured	Measurement of plasma glucose concentrations
Sponsor	Sanofi
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02713477 ↗