GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

What this study is testing ClinicalTrials.gov NCT00763451 ↗

Description as written by the study sponsor.

The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to metformin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction when it is used in two steps dose titration regimen at Week 24. Secondary objectives are to assess the effects of lixisenatide when added to metformin on glycemic control in comparison to placebo in terms of HbA1c reduction when it is used in a one-step dose titration regimen, the percentage of patients with HbA1c less than 7 percent or less than or equal to 6.5%, body weight, fasting plasma glucose (FPG); to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

Treatments tested

• Lixisenatide (AVE0010) Drug

  Self-administered by subcutaneous injections once daily within the hour preceding breakfast.

• Placebo Drug

  Self-administered by subcutaneous injections once daily within the hour preceding breakfast.

• Pen auto-injector also known as OptiClik® Device
• Metformin Drug

  Metformin to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.