drugset / Trial / NCT02688933
A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2016-05-05
- Primary completion
- 2017-06-19
- Completion
- 2017-06-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | insulin glargine | Protein / enzyme biologic | 100 iu | Subcutaneous |
| Subject | insulin glargine | Protein / enzyme biologic | 300 iu | Subcutaneous |
| Background | Insulin Lispro | Protein / enzyme biologic | — | — |
| Background | Insulin glulisine | Protein / enzyme biologic | — | — |
| Background | insulin aspart | Protein / enzyme biologic | — | — |