Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
The maximum study duration was up to approximately 54 weeks per participants:
* Up to 2-week screening period
* 6-month open-label comparative efficacy and safety treatment period
* 6-month open-label comparative safety extension period
* 48-hour post-treatment safety follow-up period
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult participants with type 1 diabetes mellitus
You may not be if
HbA1c less than (\<) 7.0% (53 mmol/mol) or greater than (\>) 10% (86 mmol/mol) at screening
Less than 1 year on any basal plus mealtime insulin and self-monitoring of blood glucose before screening visit
Participants not on stable insulin dose (+/-20 percent total basal insulin dose) in the last 30 days prior to screening visit
Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit
Use of an insulin pump in the last 6 months before screening visit and no plan to switch to insulin pump in the next 12 months
Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening;
Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit
Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (example laser, surgical treatment or injectable drugs) during the study period
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
