Overview
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
Description
The duration of the study per participant will be 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
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.