Conditions: Type 2 Diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 350
Healthy volunteers: no

Brief summary:
Primary objective:

\- To evaluate the effect of lixisenatide versus placebo over a period of 24 weeks on glycemic control, as evaluated by glycosylated hemoglobin (HbA1c) reduction, in older type 2 diabetes participants (T2DM) who are inadequately controlled with their current anti-diabetic treatment regimen.

Main secondary objective:

\- To assess the safety and tolerability of lixisenatide compared to placebo in older T2DM participants (including occurrence of documented (Plasma Glucose PG \< 60 mg/dL) symptomatic hypoglycemia and gastrointestinal side effects).

Other secondary objectives:

* To assess the effect of lixisenatide compared to placebo after 24-week treatment on:

  * Fasting plasma glucose (FPG);
  * During liquid standardized breakfast meal challenge test : 2 hour- Postprandial Plasma Glucose (PPG) and Plasma Glucose Excursion;
  * 7-point Self-monitored plasma glucose (SMPG) profile;
  * Body weight;
  * Change in total daily dose of basal insulin (if taken);
  * Percentage of participants requiring rescue therapy
  * Safety and tolerability;
* To assess lixisenatide pharmacokinetic profile;
* To assess anti-lixisenatide antibody development.

Detailed description:
Approximately 31 weeks including 24 week treatment period.

Arms:
arm 1: Lixisenatide 10 mcg once daily (QD) for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg. arm 2: Placebo (matched to lixisenatide) QD for 24 Weeks.

Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Placebo intervention 3: Antidiabetic background therapy
Intervention descriptions: intervention 1: Pharmaceutical form: Solution for injection in pre-filled pen administered 30 to 60 minutes before breakfast in the morning

Route of administration: Subcutaneous injection intervention 2: Pharmaceutical form: Solution for injection in pre-filled pen administered 30 to 60 minutes before breakfast in the morning

Route of administration: Subcutaneous injection intervention 3: Participants received a stable regimen of anti-diabetic background therapy for at least 3 months prior to screening, during the placebo run-in period and the 24 week treatment period. Allowed background antidiabetic therapy included metformin, sulfonylurea (except glibenclamide \>10 mg, gliclazide \>160 mg), meglitinides (except repaglinide \>6 mg), pioglitazone and basal insulin. Insulin glargine, neutral protamine hagedorn (NPH) insulin, detemir, lente and ultralente were considered as basal insulin.

Protocol document: