NCT02688933

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

A Randomized, Active-controlled, Parallel Group, 16-Week Open Label Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo (Insulin Glargine-U300) Versus Lantus in Patients With Type 1 Diabetes Mellitus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 638 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The maximum study duration per participant was to be of approximately 20 weeks that consisted of an up to a 4-week screening and CGM training period including a 1-2 week baseline (blinded) CGM performance (allowed for re-training), a 14-week open-label, comparative treatment period allowing for dose titration in both basal and meal-time insulin and including a 1-2 week end-of treatment blinded CGM collection with fixed dose of HOE901-U300 and Lantus, and a 2 day post treatment follow-up period.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	HOE901-U300 (Insulin Glargine 300 U/ml)	Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast) using a pre-filled pen.
DRUG	Lantus (Insulin Glargine 100 U/ml)	Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast using a pre-filled pen.
DRUG	Mandated back ground therapy	Rapid insulin analogs: e.g., insulin glulisine, insulin lispro or insulin aspart, used by participant at least 30 days before screening. Mealtime insulin was to be continued during the study and titrated towards protocol specified postprandial glucose targets (130-180 mg/dL).

Timeline

• Start date: 2016-05-05
• Primary completion: 2017-06-19
• Completion: 2017-06-19
• First posted: 2016-02-23
• Last updated: 2022-03-28
• Results posted: 2018-08-20

Locations

100 sites across 2 countries: United States, Puerto Rico