Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes

NCT01960179 · Completed

Last updated 2026-05-28

This clinical trial tested the safety of the medication lixisenatide, taken alone, in adults with type 2 diabetes over 24 and 52 weeks.

Status Completed The study has finished.

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

Type Interventional (clinical trial)

Design open-label (no blinding) treatment study

Participants 361 people

Who can join Ages 20+ · all sexes

Timeline Started 2013-11 · est. completion 2015-03

Where 30 sites · Japan

What this study is testing ClinicalTrials.gov NCT01960179 ↗

Description as written by the study sponsor.

Primary Objective: To assess the overall safety of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks in patients with type 2 diabetes in Japan Secondary Objective: To assess the effects of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks on: * HbA1c (Glycated hemoglobin A1c) reduction; * Fasting plasma glucose; * Body weight.

Treatments tested

lixisenatide AVE0010 Drug

Pharmaceutical form:solution Route of administration: Subcutaneous injection

Main thing measured	Safety over 24 and 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 NCT01960179 ↗