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

Completed · Phase 4

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT04075513

Run by

Sanofi

People needed

343

Starts

2019-10-09

Expected to finish

2021-09-16

Last updated by the study team

2022-11-14

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with Type 1 Diabetes mellitus.
• Participants treated with multiple daily injections using basal insulin analog once daily and rapid acting insulin analogs for at least one year.
• HbA1c greater than or equal to (>=) 7 percent (%) (53 millimoles per mole [mmol/mol]) and less than or equal to (<=) 10% (86 mmol/mol) at screening.

You may not qualify if…

• 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 having used the same insulins (both basal and rapid) within 30 days prior to screening.
• Participants having received basal insulin dose >= 0.6 units per kilogram 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 kilogram within 3 months prior to screening.
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• United States — Dallas, Texas, United States
• Investigational site BRAZIL — Brazil, Brazil
• Investigational site Germany — Germany, Germany
• Investigational site Hungary — Hungary, Hungary
• Investigational site Netherlands — Netherlands, Netherlands
• Investigational site Turkey — Turkey, Turkey (Türkiye)
• Investigational site United Kingdom — United Kingdom, United Kingdom

Full record on ClinicalTrials.gov

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