Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients

• Status: Completed
• Trial end date: 2015-02-01

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.

• Phase: Phase 3

Details

• Lead Sponsor: Sanofi
• Treatments: Hypoglycemic Agents; Lixisenatide