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

NCT ID: NCT02585674

Last Updated: 2016-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-11-30

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Insulin glargine (U300)

Intervention Type: DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

MyStar DoseCoach

Intervention Type: DEVICE

Glucose meter

Routine Titration

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).

Group Type: ACTIVE_COMPARATOR

Insulin glargine (U300)

Intervention Type: DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Interventions

Insulin glargine (U300)

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Intervention Type: DRUG

MyStar DoseCoach

Glucose meter

Intervention Type: DEVICE

Other Intervention Names

HOE901

Eligibility 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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, , Germany

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, , United Kingdom

Countries

Germany; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 29895556 (View on PubMed)

Other Identifiers

2014-004533-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1165-9001

Identifier Type: OTHER

Identifier Source: secondary_id

EFC13470

Identifier Type: -

Identifier Source: org_study_id