Comparison of MyStar DoseCoach to Routine Titration in Adult Patients With Type 2 Diabetes Mellitus Using Toujeo

Summary

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

Timeline

Start

2015-12

Primary completion

2016-11

Completion

2016-11

Publications

• Ritzel R, Harris SB, Baron H, Florez H, Roussel R, Espinasse M, Muehlen-Bartmer I, Zhang N, Bertolini M, Brulle-Wohlhueter C, Munshi M, Bolli GB. A Randomized Controlled Trial Comparing Efficacy and Safety of Insulin Glargine 300 Units/mL Versus 100 Units/mL in Older People With Type 2 Diabetes: Results From the SENIOR Study. Diabetes Care. 2018 Aug;41(8):1672-1680. doi: 10.2337/dc18-0168. Epub 2018 Jun 12.

Drugs

Indications