Safety Assessment of Lyxumia (Lixisenatide) and Sulfonylurea as Add-on Treatment to Basal Insulin in Uncontrolled Patients With Type 2 Diabetes Mellitus Who Elect to Fast During Ramadan

• Status: Completed
• Trial end date: 2017-08-04

Summary

Primary Objective:

To compare the safety, in terms of percentage of patients with symptomatic documented hypoglycemia during Ramadan fast, of lixisenatide versus sulfonylurea (SU).

Secondary Objectives:

• To assess effect of lixisenatide versus SU on:

• Changes in glycemic control;

• Changes in body weight.

• To assess overall safety of lixisenatide and SU.

• Phase: Phase 4

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin, Globin Zinc; Lixisenatide; Metformin