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

Type 2 Diabetes Clinical Trial

Official title: A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter, 24 Week Study Assessing the Safety and Efficacy of Lixisenatide in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Diabetes Treatment Regimen

Status Completed

Clinical Trial Summary

Primary objective:

• To evaluate the effect of lixisenatide versus placebo over a period of 24 weeks on glycemic control, as evaluated by HbA1c reduction, in older type 2 diabetes patients (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 patients (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- 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 patients requiring rescue therapy

• Safety and tolerability

• To assess lixisenatide pharmacokinetic profile

• To assess anti-lixisenatide antibody development.

Clinical Trial Description

Approximately 31 weeks including 24 week treatment period ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

• NCT number: NCT01798706
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 3
• Start date: June 2013
• Completion date: February 2015