Clinical trial NCT00975286
Conditions: Type 2 Diabetes Mellitus
Sponsor: Sanofi
Start date: 2009-10-01; Completion date: 2011-08-01
Enrollment: 446 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:
The study comprises 3 periods:

* An up to 14-week screening period, which includes an up to 2-week screening phase and a 12-week run-in phase with introduction and titration of insulin glargine on top of metformin +/-TZDs.
* At the end of the run-in phase, patients whose HbA1c (centralized assay) is greater than or equal to (\>=) 7% and less than or equal to (\<=) 9% and whose mean fasting self-monitored plasma glucose (SMPG) calculated from the self measurements for the 7 days prior to Visit 12 (Week -1) is \<=140 milligram per deciliter (mg/dL) (7.8 millimole per liter \[mmol/L\]), would enter a 24-week double-blind randomized treatment period comparing lixisenatide to placebo (on top of insulin glargine + metformin +/- TZDs).
* A 3-day safety follow up period.

Maximum duration is of 39 weeks +/- 7 days.

Arms: arm 1: 2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24. arm 2: 2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Placebo intervention 3: Insulin glargine intervention 4: Pen auto-injector intervention 5: Metformin intervention 6: Thiazolidinedione (TZD)
Intervention descriptions: intervention 1: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 2: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 3: Dose to be adjusted to maintain a fasting SMPG between 100 and 80 mg/dL (5.6 and 4.4 mmol/L), inclusive. intervention 4: Lantus® SoloStar® OptiClik® intervention 5: Metformin to be continued at stable dose (at least 1.5 gram per day) up to Week 24. intervention 6: TZD (either rosiglitazone or pioglitazone) if given, to be continued at stable dose up to Week 24.

Protocol documents: