NCT04075513

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Insulin glargine, 300 U/ml	Pharmaceutical form: solution for injection in a prefilled pen Route of administration: SC injection
DRUG	Insulin degludec, 100U/ml	Pharmaceutical form: solution for injection in a prefilled pen Route of administration: SC injection
DRUG	Background therapy: Rapid acting insulin analogs	Route of administration: SC injection

Timeline

• Start date: 2019-10-09
• Primary completion: 2021-09-16
• Completion: 2021-09-16
• First posted: 2019-08-30
• Last updated: 2022-11-14
• Results posted: 2022-11-14

Locations

7 sites across 7 countries: United States, Brazil, Germany, Hungary, Netherlands, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study