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

Type 2 Diabetes Mellitus Clinical Trial

— AUTOMATIX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585674
• Other study ID #: EFC13470
• Secondary ID: 2014-004533-13U1
• Status: Completed
• Phase: Phase 3
• First received: October 22, 2015
• Last updated: December 5, 2016
• Start date: December 2015
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Exclusion criteria:

• Aged <18 years.

• Diabetes other than type 2 diabetes mellitus.

• MyStar DoseCoach device is not appropriate for the patient or use of device is otherwise contraindicated (in the opinion of the Investigator).

• Conditions/situations that are contraindications or off-label use according to Summary of Product Characteristics (SmPCs) of Oral Anti-Diabetes Drugs (OADs) and/or GLP-1 receptor agonists when applicable (prescribed), or insulin glargine and as defined in the national product label.

• Patients not on stable dose of glucose lowering therapy including OADs, GLP-1 receptor agonists, or basal insulin therapy, for the last 3 months (stable basal insulin therapy defined as maximum change in insulin dose of +/- 20%).

• Patients using mealtime insulin (short acting analogue, human regular insulin, or premix insulin) for more than 10 days in the last 3 months before screening visit.

• Patients with hypoglycemia unawareness.

• Patients with severe hypoglycemia in the past 90 days.

• Hospitalization in the past 30 days.

• Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 90 days prior to the time of screening.

• Unable to meet specific protocol requirements (eg, inability to perform blood glucose measurements, manage their own insulin glargine administration, or deemed unlikely to safely manage titration based on guidance by their health care provider or HCP, etc.), because of a medical condition or because the patient is under legal guardianship.

• Patients with cognitive disorders, dementia, or any neurologic disorder that would affect a patient's ability to participate in the study, including the inability to understand study requirements or to give complete information about adverse symptoms.

• Conditions/situations such as:

• Patients with conditions/concomitant diseases precluding their safe participation in this study (eg, active malignant tumor, major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema likely to require treatment within the study period, etc.),

• Patients unable to fully understand study documents and to complete them. Patients who have a caregiver together with whom they can fulfill all study requirements are eligible,

• Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.

• Within the last 3 months prior to screening: history of myocardial infarction, unstable angina, acute coronary syndrome, revascularization procedure, or stroke requiring hospitalization.

• Severe or uncontrolled Congestive Heart Failure (New York Heart Association [NYHA] functional classification III and IV); or inadequately controlled hypertension at the time of screening with a resting systolic or diastolic blood pressure >180 mmHg or >95 mmHg, respectively.

• Pregnant or breast-feeding 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 of childbearing potential (premenopausal, not surgically sterile for at least 3 months prior to the time of screening) must use an effective contraceptive method throughout the study. Effective methods of contraception include barrier methods (in conjunction with spermicide), hormonal contraception, or use of an intrauterine device (IUD) or intrauterine hormone-releasing system (IUS).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Insulin glargine (U300)
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Device:
• MyStar DoseCoach
Glucose meter

Locations

Country	Name	City	State
Germany	Investigational Site Number 276002	Berlin
Germany	Investigational Site Number 276001	Dresden
Germany	Investigational Site Number 276007	Essen
Germany	Investigational Site Number 276003	Heidelberg
Germany	Investigational Site Number 276010	Künzing
Germany	Investigational Site Number 276005	Neumünster
Germany	Investigational Site Number 276004	Oldenburg In Holstein
Germany	Investigational Site Number 276006	Pirna
Germany	Investigational Site Number 276008	Sulzbach-Rosenberg
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 826006	Dumfries
United Kingdom	Investigational Site Number 826008	East Kilbride
United Kingdom	Investigational Site Number 826005	Larbert
United Kingdom	Investigational Site Number 826010	Londonderry
United Kingdom	Investigational Site Number 826009	Swansea
United Kingdom	Investigational Site Number 826007	Taunton

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Percentage of patients reaching laboratory FPG target range (90-130 mg/dL) without severe hypoglycemia		Baseline to Week 16	No
Secondary	Mean FSMPG glucose change from baseline (mean of the last 5 readings recorded over the last 2 weeks)		Baseline to Week 16	No
Secondary	Time to reach the first fasting SMPG target range of 90-130 mg/dL (5.0-7.2 mmol/L)		Baseline to Week 16	No
Secondary	Mean FPG glucose change from baseline		Baseline to Week 16	No
Secondary	Mean HbA1c change from baseline		Baseline to Week 16	No
Secondary	Percentage of patients reaching HbA1c of <7.5% and <7%		Week 16	No
Secondary	Percentage of patients with hypoglycemic events		Baseline to Week 16	Yes
Secondary	Number of hypoglycemic events		Baseline to Week 16	Yes
Secondary	Percentage of patients with adverse events		Baseline to Week 16	Yes
Secondary	Percentage of patients with serious adverse events		Baseline to Week 16	Yes
Secondary	Assessment of satisfaction with diabetes treatment using Diabetes Treatment Satisfaction Questionnaire		Baseline to Week 16	No
Secondary	Assessment of fear of hypoglycemia using Hypoglycemia Fear Survey-II		Baseline to Week 16	No
Secondary	Assessment of emotional well-being using WHO-5 well-being index		Baseline to Week 16	No
Secondary	Assessment of diabetes-related emotional stress using Diabetes Distress Scale		Baseline to Week 16	No
Secondary	Assessment of satisfaction with glucose monitoring using the Glucose Monitoring Satisfaction Survey		Baseline to Week 16	No
Secondary	Assessment of device Ease of Use using Ease of Use questionnaire		Baseline to Week 16	No