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

What this study is testing ClinicalTrials.gov NCT00715624 ↗

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 basal insulin with or without 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 basal insulin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction at Week 24. The secondary objectives are to assess the effects of lixisenatide when added to basal insulin on body weight, 2-hour postprandial plasma glucose (PPG) after standardized meal challenge test, percentage of patients reaching HbA1c less than 7 percent (%), percentage of patients reaching HbA1c less than or equal to 6.5%, fasting plasma glucose (FPG), change in 7-point self-monitored plasma glucose (SMPG) profiles, change in basal insulin and total insulin doses; to evaluate 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.

• Basal Insulin Drug

  Dose to be kept stable.

• Metformin Drug

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

• Pen auto-injector also known as OptiClik® Device