Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients

Phase 4 Completed 343 enrolled Sanofi

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2019-10-09
Primary completion: 2021-09-16
Completion: 2021-09-16

Outcome

Met primary endpoint

registry analysis (non-inferiority test); Toujeo vs Tresiba; p = 0.0067; Least square mean difference 3.16 (95% CI 0.88 to 5.44); NCT04075513 ↗

Publications

Battelino T, Bosnyak Z, Danne T, Mukherjee B, Edelman S, Pilorget V, Choudhary P, Renard E, Bergenstal R. InRange: Comparison of the Second-Generation Basal Insulin Analogues Glargine 300 U/mL and Degludec 100 U/mL in Persons with Type 1 Diabetes Using Continuous Glucose Monitoring-Study Design. Diabetes Ther. 2020 Apr;11(4):1017-1027. doi: 10.1007/s13300-020-00781-6. Epub 2020 Feb 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	insulin degludec	Protein / enzyme biologic	100 unknown	Subcutaneous
Subject	insulin glargine	Protein / enzyme biologic	300 unknown	Subcutaneous