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

Last updated: December 5, 2016
Sponsor: Sanofi
Overall Status: Completed

Phase

3

Condition

Hypertriglyceridemia

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Treatment

N/A

Clinical Study ID

NCT02585674
EFC13470
2014-004533-13
U1111-1165-9001
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion criteria :

  • Patients with type 2 diabetes mellitus diagnosed at least one year before thescreening visit.

  • Patients who are insulin naïve (and considered by the investigator to be appropriatecandidates for basal insulin therapy), or treated with basal insulin as their onlyinsulin.

  • 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

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 isotherwise contraindicated (in the opinion of the Investigator).

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

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

  • Patients using mealtime insulin (short acting analogue, human regular insulin, orpremix 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) forone week or more within 90 days prior to the time of screening.

  • Unable to meet specific protocol requirements (eg, inability to perform blood glucosemeasurements, manage their own insulin glargine administration, or deemed unlikely tosafely 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 wouldaffect a patient's ability to participate in the study, including the inability tounderstand study requirements or to give complete information about adverse symptoms.

  • Conditions/situations such as:

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

  • Patients unable to fully understand study documents and to complete them. Patients whohave a caregiver together with whom they can fulfill all study requirements areeligible,

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

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

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

  • Pregnant or breast-feeding women or women who intend to become pregnant during thestudy period as glycemic control may be unstable and insulin doses may be variableduring this period.

  • Women of childbearing potential (premenopausal, not surgically sterile for at least 3months prior to the time of screening) must use an effective contraceptive methodthroughout the study. Effective methods of contraception include barrier methods (inconjunction 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'spotential participation in a clinical trial.

Study Design

Total Participants: 151
Study Start date:
December 01, 2015
Estimated Completion Date:
November 30, 2016

Study 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.

Connect with a study center

  • Investigational Site Number 276002

    Berlin, 10115
    Germany

    Site Not Available

  • Investigational Site Number 276001

    Dresden, 01307
    Germany

    Site Not Available

  • Investigational Site Number 276007

    Essen, 45359
    Germany

    Site Not Available

  • Investigational Site Number 276003

    Heidelberg, 69115
    Germany

    Site Not Available

  • Investigational Site Number 276010

    Künzing, 94550
    Germany

    Site Not Available

  • Investigational Site Number 276005

    Neumünster, 24534
    Germany

    Site Not Available

  • Investigational Site Number 276004

    Oldenburg In Holstein, 23758
    Germany

    Site Not Available

  • Investigational Site Number 276006

    Pirna, 01796
    Germany

    Site Not Available

  • Investigational Site Number 276008

    Sulzbach-Rosenberg, 92237
    Germany

    Site Not Available

  • Investigational Site Number 826003

    Airdrie, ML6 OJS
    United Kingdom

    Site Not Available

  • Investigational Site Number 826002

    Belfast, BT12 6BA
    United Kingdom

    Site Not Available

  • Investigational Site Number 826011

    Bristol, BS10 5NB
    United Kingdom

    Site Not Available

  • Investigational Site Number 826001

    Chester, CH2 1UL
    United Kingdom

    Site Not Available

  • Investigational Site Number 826006

    Dumfries, DG1 4AP
    United Kingdom

    Site Not Available

  • Investigational Site Number 826008

    East Kilbride, G75 8RG
    United Kingdom

    Site Not Available

  • Investigational Site Number 826005

    Larbert, FK5 4WR
    United Kingdom

    Site Not Available

  • Investigational Site Number 826010

    Londonderry, BT47 6SB
    United Kingdom

    Site Not Available

  • Investigational Site Number 826009

    Swansea, SA6 6NL
    United Kingdom

    Site Not Available

  • Investigational Site Number 826007

    Taunton, TA1 5DA
    United Kingdom

    Site Not Available

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