Type 1 Diabetes Mellitus Clinical Trial
Official title:
A 12-week Randomized, Controlled Trial to Compare TOUJEO® and TRESIBA® in Terms of Glucose Values in Target Range and Variability During Continuous Glucose Monitoring in Patients With Type 1 Diabetes Mellitus
Primary Objective: To demonstrate the non-inferiority of insulin glargine 300 units per milliliter (U/ml) in comparison to insulin degludec 100 U/ml on glycemic control and variability in participants with diabetes mellitus. Secondary Objective: To evaluate the glycemic control and variability parameters in each treatment group at Week 12 using Continuous Glucose Monitoring. To evaluate the safety of insulin glargine 300 U/ml in comparison to insulin degludec 100 U/ml.
The duration of the study per participant was around 18 weeks: 1 or 2 weeks of screening followed by a 4-week run-in period, a 12-week treatment period and a 2 to 4 days follow-up period. ;
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