Comparison of MyStar DoseCoach to routine titration in Adult Patients with Type 2 Diabetes Mellitus using Toujeo

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 - AUTOMATIX

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004533-13-GB

Enrollment

148

Registered

2015-05-08

Start date

2015-07-17

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus MedDRA version: 18.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: HOE901 Product Code: HOE901 Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: INSULIN GLARGINE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes mellitus diagnosed at least one year before the screening visit. Patients who are insulin naïve (and considered by the investigator to be appropriate candidates for basal insulin therapy), or treated with basal insulin as their only insulin. HbA1c between 7.5% and 11% (inclusive) at screening. Fasting SMPG >130 mg/dL at first screening and FSMPG >130 mg/dL at randomization. Signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 111 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 37

Exclusion criteria

Exclusion criteria: Aged 180 mmHg or >95 mmHg, respectively. Pregnant or breastfeeding women or women who intend to become pregnant during the study period as glycemic control may be unstable and insulin doses may be variable during this period. Women

Design outcomes

Primary

Measure	Time frame
Main 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;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: Baseline to Week 16	—

Measure

Time frame

Main 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;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: Baseline to Week 16

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Secondary

Measure	Time frame
Secondary end point(s): Percentage of patients reaching fasting SMPG target range of 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 severe and/or confirmed hypoglycemic events during the 16-week on-treatment period Percentage of patients reaching laboratory FPG target range (90- 130 mg/dL) at Week 16 without severe hypoglycemia during the 16-week on-treatment period Mean FSMPG glucose change from baseline to Week 16 (mean of the last 5 readings recorded over the last 2 weeks) Time to reach the first fasting SMPG target range of 90-130 mg/dL (5.0-7.2 mmol/L) Mean FPG glucose change from baseline to Week 16 Mean HbA1c change from baseline to Week 16 Percentage of patients reaching HbA1c of <7.5% and <7% at Week 16 Percentage of patients with hypoglycemic events Number of hypoglycemic events Percentage of patients with adverse events Percentage of patients with serious adverse events Assessment of satisfaction with diabetes treatment using Diabetes Treatment Satisfaction Questionnaire) Assessment of fear of hypoglycemia using Hypoglycemia Fear Survey-II Assessment of emotional well-being using WHO-5 well-being index Assessment of diabetes-related emotional stress using Diabetes Distress Scale Assessment of satisfaction with glucose monitoring using the Glucose Monitoring Satisfaction Survey Assessment of device Ease of Use using Ease of Use questionnaire ; Timepoint(s) of evaluation of this end point: Baseline to Week 16 for all secondary endpoints, except : Percentage of patients reaching HbA1c of <7.5% and <7% at Week 16	—

Measure

Time frame

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

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Countries

Austria, Germany, Switzerland, United Kingdom

Contacts

Public ContactMedical Information

Aventis Pharma Limited, trading as Sanofi

uk-medicalinformation@sanofi.com+441483505515

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026