Status:
COMPLETED
Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients
Lead Sponsor:
Sanofi
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 participant...
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2021
Estimated Enrollment :
343 Patients enrolled
Trial Details
Trial ID
NCT04075513
Start Date
October 9 2019
End Date
September 16 2021
Last Update
November 14 2022
Active Locations (7)
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1
United States
Dallas, Texas, United States, 75000
2
Investigational site BRAZIL
Brazil, Brazil
3
Investigational site Germany
Germany, Germany
4
Investigational site Hungary
Hungary, Hungary