GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy (GETGOAL-MONO Japan LTS)

NCT00905255 · Completed

Last updated 2026-05-28

This clinical trial tested the safety of the diabetes medication lixisenatide in adults with type 2 diabetes who were not taking other diabetes treatments.

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 69 people

Who can join Ages 20+ · all sexes

Timeline Started 2009-05 · est. completion 2011-01

Where 1 site · Japan

What this study is testing ClinicalTrials.gov NCT00905255 ↗

Description as written by the study sponsor.

The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) used as 2-step initiation regimen and 1-step initiation regimen in Japan, over a period of 24 weeks of treatment, followed by an extension up to Week 76. The primary objective of this study is to evaluate the safety of lixisenatide once daily treatment in monotherapy at Week 24 by a descriptive comparison of a 1-step initiation and a 2-step initiation regimen in patients with type 2 diabetes in Japan. The secondary objectives are to assess the overall safety of lixisenatide once daily treatment in monotherapy at Week 52 and Week 76; to assess the effects of lixisenatide on glycosylated hemoglobin (HbA1c) reduction at Week 52 and Week 76, body weight, and fasting plasma glucose (FPG); to assess pharmacokinetics (PK) and anti-lixisenatide antibody development.

Treatments tested

Lixisenatide (AVE0010) Drug

Self administered by subcutaneous injections once daily within the hour preceding breakfast.
Pen auto-injector also known as OptiClik® Device

Main thing measured	Overview of Adverse Event Profile (Treatment Emergent Adverse Events) of the One-Step and Two-Step Titration Arms Assessed Through Adverse Events Collection and Vital Signs, Electrocardiogram (ECG) and Laboratory Monitoring
Sponsor	Sanofi
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00905255 ↗