24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine

What this study is testing ClinicalTrials.gov NCT00975286 ↗

Description as written by the study sponsor.

The purpose of the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment. The primary objective is to assess the effects of lixisenatide in comparison to placebo, when added to insulin glargine and metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on the percentage of patients reaching HbA1c less than (\<) 7 percent (%) and less than or equal to (\<=) 6.5%, plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability (including anti-lixisenatide antibody assessment), and to assess the impact on treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the participating countries where it is validated.

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.

• Insulin glargine also known as Lantus® Drug

  Dose to be adjusted to maintain a fasting SMPG between 100 and 80 mg/dL (5.6 and 4.4 mmol/L), inclusive.

• Pen auto-injector Device

  Lantus® SoloStar® OptiClik®

• Metformin Drug

  Metformin to be continued at stable dose (at least 1.5 gram per day) up to Week 24.

• Thiazolidinedione (TZD) Drug

  TZD (either rosiglitazone or pioglitazone) if given, to be continued at stable dose up to Week 24.