At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Insulin glargine, 300 U/ml, Insulin degludec, 100U/ml, and 1 other intervention for Type 1 Diabetes Mellitus. Completed, enrolled 343 participants across 7 sites in 7 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Pharmaceutical form: solution for injection in a prefilled pen Route of administration: SC injection
Pharmaceutical form: solution for injection in a prefilled pen Route of administration: SC injection
Route of administration: SC injection