Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

What this study is testing ClinicalTrials.gov NCT01632163 ↗

Description as written by the study sponsor.

Primary Objective: \- To assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to basal insulin with or without metformin in terms of HbA1c reduction over a period of 24 weeks in insufficiently controlled type 2 diabetic patients. Secondary Objectives: * To assess the effects of lixisenatide over 24 weeks on : * percentage of patients reaching HbA1c\<7% or ≤6.5%, * 2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during standardized meal challenge test, * fasting plasma glucose (FPG), * change in 7-point self-monitored plasma glucose (SMPG) profile), * body weight, * change in daily basal insulin dose. * To assess lixisenatide safety and tolerability. * To assess anti-lixisenatide antibody development.

Treatments tested

• Lixisenatide (AVE0010) Drug

  Pharmaceutical form:solution Route of administration: subcutaneous injection

• Placebo Drug

  Pharmaceutical form:solution Route of administration: subcutaneous injection