Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 451
Healthy volunteers: no

Brief summary:
Primary Objective:

\- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24)

Secondary Objective:

* To assess the effect of the 2 lixisenatide regimens on:

  * The percentage of participants who reached the target of HbA1c \< 7% or ≤ 6.5% at Week 24
  * Fasting Plasma Glucose (FPG)
  * 7-point Self-Monitored Plasma Glucose (SMPG) profiles
  * Body weight
* To assess the safety and tolerability of the 2 lixisenatide regimens

Detailed description:
The maximum study duration was 28 weeks per participant, including a 24-week randomized treatment period.

Arms:
arm 1: Lixisenatide 10 mcg once daily (QD) within 1 hour before "main meal of the day" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24. arm 2: Lixisenatide 10 mcg QD within 1 hour before "breakfast" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.

Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Self-injector pen device (OptiClik®) intervention 3: Metformin
Intervention descriptions: intervention 1: Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous intervention 2: None intervention 3: To be kept at stable dose (≥1.5 g/day) throughout the study.

Protocol document: