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

NCT04075513

CompletedPhase 4

Sponsor: Sanofi

Conditions: Type 1 Diabetes Mellitus

Interventions: Insulin glargine, 300 U/ml, Insulin degludec, 100U/ml, Background therapy: Rapid acting insulin analogs

Countries: United States, Brazil, Germany, Hungary, Netherlands, Turkey (Türkiye), United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria :

* 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.

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 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.
Locations (7)
  • Dallas, Texas, United States
  • Brazil, Brazil
  • Germany, Germany
  • Hungary, Hungary
  • Netherlands, Netherlands
  • Turkey, Turkey (Türkiye)
  • United Kingdom, United Kingdom