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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Insulin glargine (U300); Device: MyStar DoseCoach

• Registration Number: NCT02585674
• Lead Sponsor: Sanofi

Brief 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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-23
• Study Start: 2015-12
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MyStar DoseCoach	MyStar DoseCoach	MyStar DoseCoach - Device-supported treat-to-target regimen. Insulin glargine is administered subcutaneously on top of potential background therapy using oral anti-diabetic drug(s) or GLP1 RA injectable antihyperglycemic drug(s).
MyStar DoseCoach	Insulin glargine (U300)	MyStar DoseCoach - Device-supported treat-to-target regimen. Insulin glargine is administered subcutaneously on top of potential background therapy using oral anti-diabetic drug(s) or GLP1 RA injectable antihyperglycemic drug(s).
Routine Titration	Insulin glargine (U300)	Routine Titration - Routine titration defined by the Investigator. Insulin glargine is administered subcutaneously on top of potential background therapy using oral anti-diabetic drug(s) or GLP1 RA injectable antihyperglycemic drug(s).

Primary Outcome Measures

Name	Time	Method
Percentage of patients reaching fasting SMPG target range 90-130 mg/dL (5.0-7.2 mmol/L) at Week 16 (mean of the last 5 readings recorded over the last 2 weeks) without a severe hypoglycemic episode during the 16-week on-treatment period	Baseline to Week 16

Secondary Outcome Measures

Name	Time	Method
Assessment of satisfaction with diabetes treatment using Diabetes Treatment Satisfaction Questionnaire	Baseline to Week 16
Percentage of patients reaching HbA1c of <7.5% and <7%	Week 16
Percentage of patients with adverse events	Baseline to Week 16
Assessment of diabetes-related emotional stress using Diabetes Distress Scale	Baseline to Week 16
Percentage of patients reaching laboratory FPG target range (90-130 mg/dL) without severe hypoglycemia	Baseline to Week 16
Mean FSMPG glucose change from baseline (mean of the last 5 readings recorded over the last 2 weeks)	Baseline to Week 16
Number of hypoglycemic events	Baseline to Week 16
Percentage of patients reaching fasting SMPG target range of 90-130 mg/dL (5.0-7.2 mmol/L), (mean of the last 5 readings recorded over the last 2 weeks) without severe and/or confirmed hypoglycemic events	Baseline to Week 16
Percentage of patients with serious adverse events	Baseline to Week 16
Assessment of emotional well-being using WHO-5 well-being index	Baseline to Week 16
Time to reach the first fasting SMPG target range of 90-130 mg/dL (5.0-7.2 mmol/L)	Baseline to Week 16
Mean FPG glucose change from baseline	Baseline to Week 16
Mean HbA1c change from baseline	Baseline to Week 16
Percentage of patients with hypoglycemic events	Baseline to Week 16
Assessment of fear of hypoglycemia using Hypoglycemia Fear Survey-II	Baseline to Week 16
Assessment of satisfaction with glucose monitoring using the Glucose Monitoring Satisfaction Survey	Baseline to Week 16
Assessment of device Ease of Use using Ease of Use questionnaire	Baseline to Week 16

Trial Locations

Locations (19)

Investigational Site Number 826010; 🇬🇧 Londonderry, United Kingdom

Investigational Site Number 826006; 🇬🇧 Dumfries, United Kingdom

Investigational Site Number 826008; 🇬🇧 East Kilbride, United Kingdom

Investigational Site Number 826003; 🇬🇧 Airdrie, United Kingdom

Investigational Site Number 826002; 🇬🇧 Belfast, United Kingdom

Investigational Site Number 826011; 🇬🇧 Bristol, United Kingdom

Investigational Site Number 826001; 🇬🇧 Chester, United Kingdom

Investigational Site Number 826005; 🇬🇧 Larbert, United Kingdom

Investigational Site Number 826009; 🇬🇧 Swansea, United Kingdom

Investigational Site Number 276002; 🇩🇪 Berlin, Germany

Investigational Site Number 276007; 🇩🇪 Essen, Germany

Investigational Site Number 276010; 🇩🇪 Künzing, Germany

Investigational Site Number 276005; 🇩🇪 Neumünster, Germany

Investigational Site Number 276004; 🇩🇪 Oldenburg In Holstein, Germany

Investigational Site Number 276003; 🇩🇪 Heidelberg, Germany

Investigational Site Number 826007; 🇬🇧 Taunton, United Kingdom

Investigational Site Number 276001; 🇩🇪 Dresden, Germany

Investigational Site Number 276006; 🇩🇪 Pirna, Germany

Investigational Site Number 276008; 🇩🇪 Sulzbach-Rosenberg, Germany