Type 2 Diabetes Mellitus Clinical Trial
Official title:
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
The maximum study duration will be 21 weeks per patient that will consist of a 4-week screening period, a 16-week treatment period, and 1-week follow-up period. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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