Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes

NCT01940965 · Completed

Last updated 2026-05-28

This clinical trial tested the safety of the medication lixisenatide, when added to standard oral diabetes treatments, in adults with type 2 diabetes over a 52-week period.

Status Completed The study has finished.

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

Type Interventional (clinical trial)

Design Non-randomized, open-label (no blinding) treatment study

Participants 294 people

Who can join Ages 20+ · all sexes Healthy volunteers accepted.

Timeline Started 2013-09 · est. completion 2015-07

Where 27 sites · Japan

What this study is testing ClinicalTrials.gov NCT01940965 ↗

Description as written by the study sponsor.

Primary Objective: The primary objective of this study is to assess the overall safety of lixisenatide once daily treatment in combination with background oral anti-diabetic treatment over 52 weeks in patients with type 2 diabetes in Japan. Secondary Objective: To assess the effects of lixisenatide in combination with background oral antidiabetic drug (OAD) on: * HbA1c; * Fasting plasma glucose; * Body weight.

Treatments tested

lixisenatide AVE0010 Drug

Pharmaceutical form:solution Route of administration: Subcutaneous injection
biguanide Drug

Pharmaceutical form:tablet Route of administration: oral
TZD Drug

Pharmaceutical form:tablet Route of administration: oral
alpha-GI Drug

Pharmaceutical form:tablet Route of administration: oral
glinide Drug

Pharmaceutical form:tablet Route of administration: oral

Main thing measured	Safety over 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data
Sponsor	Sanofi
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01940965 ↗