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

• Status: Completed
• Trial end date: 2021-09-16
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc; Insulin, Long-Acting; Insulin, Short-Acting

Criteria

Inclusion criteria :

• Participants with Type 1 Diabetes mellitus (T1DM)

• Participants treated with multiple daily injections (MDI) using basal insulin analog once daily and rapid acting insulin analogs for at least one year

• HbA1c ≥ 7% (48 mmol/mol) and ≤ 10% (86 mmol/mol) at screening

Exclusion criteria:

• Participants not on stable dose of basal insulin analog

• Participants having received Toujeo or Tresiba as basal insulin within 30 days prior to screening

• Participants not using the same insulins (both basal and rapid) within 30 days prior to screening

• Participants having received basal insulin dose ≥0.6 U/kg body weight within 30 days prior to screening

• Participants having received any glucose lowering drugs (including any premixed insulins,human regular insulin as mealtime insulins, any others injectable or oral), other than basal and rapid insulin analogs, within 3 months prior to screening

• End stage renal disease or on renal replacement treatment

• Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months prior to screening) or planned: intravitreal injections or laser or vitrectomy surgery Body weight change ≥5 kg within 3 months prior to screening

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.