A 21-Week, Open-label, Randomized, Controlled, Parallel-group, Multi-center Study Evaluating the Efficacy and Safety of HOE901-U300 Administered According to a Device-Supported Treat-to-target Regimen Versus Routine Titration in Patients With Type 2 Diabetes Mellitus

Primary Objective:

To demonstrate the non-inferiority of the MyStar DoseCoach (Long-acting Insulin Glargine
Titration Meter) device-supported treat-to-target regimen relative to a routine titration
regimen in the percentage of patients reaching glycemic target, ie, with a mean fasting
self-monitored plasma glucose (FSMPG) value within the target range of 90-130 mg/dL (5.0-7.2
mmol/L) without a severe hypoglycemic episode during the 16-week on-treatment period.

Secondary Objective:

To assess the efficacy, safety, and adherence/satisfaction of MyStar DoseCoach