Clareo Health | Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
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.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.