At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating HOE901-U300 (Insulin Glargine 300 U/ml), Lantus (Insulin Glargine 100 U/ml), and 1 other intervention for Type 1 Diabetes Mellitus. Completed, enrolled 638 participants across 100 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast) using a pre-filled pen.
Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast using a pre-filled pen.
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).