A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus

• Status: Completed
• Trial end date: 2017-06-19

Summary

Primary Objective:

To demonstrate that morning injection of Toujeo (HOE901-U300) compared to Lantus provides better glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult participants with type 1 diabetes mellitus.

Secondary Objective:

To demonstrate that treatment with HOE901-U300 compared to Lantus provides:

• Lower incidence rate of nocturnal symptomatic hypoglycemia;

• Better glucose control coverage during the last hours of CGM before next basal-insulin dosing;

• Less variability in CGM profile.

• Phase: Phase 4

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Aspart; Insulin Glargine; Insulin glulisine; Insulin Lispro; Insulin, Globin Zinc