Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients
-
- STATUS
- Recruiting
-
- participants needed
- 338
-
- sponsor
- Sanofi
Summary
Primary Objective:
To demonstrate the noninferiority of insulin glargine 300 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 (CGM)
To evaluate the safety of insulin glargine 300 U/mL in comparison to insulin degludec 100 U/mL
Description
The duration of the study per participant will be 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
Details
| Condition | Diabetes Mellitus, Diabetes Mellitus Types I and II, diabetes prevention, diabetes (pediatric), Insulin dependent diabetes mellitus, diabetes mellitus, type 1, diabetes (pediatric), Diabetes Mellitus Types I and II, diabetes prevention, diabetes mellitus, type 1, type 1 diabetes mellitus |
|---|---|
| Age | 18years - 70years |
| Treatment | Insulin glargine, 300 U/ml, Insulin degludec, 100U/ml, Background therapy: Rapid acting insulin analogs |
| Clinical Study Identifier | NCT04075513 |
| Sponsor | Sanofi |
| Last Modified on | 21 July 2021 |
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