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

• Percentage of patients with HbA1c <7%, =<6.5% [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
• Change in 2-hour postprandial plasma glucose and plasma glucose excursion [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
• Change in fasting plasma glucose [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
• Change in 7-point self monitoring plasma glucose profile (average and each point) [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
• Change in body weight [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
• Change in daily basal insulin dose [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
• Number of patients with adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
• Anti-lixisenatide antibody assessment [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: Yes ]

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.

Maximum study duration of approximately 35 weeks ± 9 days (up to 2 weeks screening + 8 weeks run-in + 24 weeks double-blind treatment+ 3 days follow-up)

• Drug: Lixisenatide (AVE0010)

  Pharmaceutical form:solution

  Route of administration: subcutaneous injection

• Drug: Placebo

  Pharmaceutical form:solution

  Route of administration: subcutaneous injection

• Experimental: Lixisenatide
  24-week treatment with lixisenatide once daily on top of basal insulin with or without metformin (at least 1.0g/day)
  Intervention: Drug: Lixisenatide (AVE0010)
• Placebo Comparator: Placebo
  24-week treatment with placebo once daily on top of basal insulin with or without metformin (at least 1.0g/day)
  Intervention: Drug: Placebo

Inclusion criteria :

- Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year at the time of the screening visit insufficiently controlled with basal insulin± metformin.

Exclusion criteria:

At screening:

• Age < legal age of adulthood.
• HbA1c<7% or >10.5%.
• Basal insulin treatment has not been at a stable regimen for at least 3 months and at a stable dose (± 20%) of at least 15 U/day for at least 2 months prior to screening visit.
• If metformin is given, metformin treatment has not been at a stable dose of at least 1.0 g/day for at least 3 months prior to screening visit.
• History of hypoglycemia unawareness.
• Body Mass Index (BMI) ≤20 kg/m².
• Use of other oral or injectable glucose-lowering agents other than basal insulin or metformin within 3 months prior to the time of screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.