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

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ClinicalTrials.gov Identifier: NCT02585674
Recruitment Status : Completed
First Posted : October 23, 2015
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE October 22, 2015
First Posted Date  ICMJE October 23, 2015
Last Update Posted Date December 6, 2016
Study Start Date  ICMJE December 2015
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2015)
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 [ Time Frame: Baseline to Week 16 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2015)
  • 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 [ Time Frame: Baseline to Week 16 ]
  • Percentage of patients reaching laboratory FPG target range (90-130 mg/dL) without severe hypoglycemia [ Time Frame: Baseline to Week 16 ]
  • Mean FSMPG glucose change from baseline (mean of the last 5 readings recorded over the last 2 weeks) [ Time Frame: Baseline to Week 16 ]
  • Time to reach the first fasting SMPG target range of 90-130 mg/dL (5.0-7.2 mmol/L) [ Time Frame: Baseline to Week 16 ]
  • Mean FPG glucose change from baseline [ Time Frame: Baseline to Week 16 ]
  • Mean HbA1c change from baseline [ Time Frame: Baseline to Week 16 ]
  • Percentage of patients reaching HbA1c of <7.5% and <7% [ Time Frame: Week 16 ]
  • Percentage of patients with hypoglycemic events [ Time Frame: Baseline to Week 16 ]
  • Number of hypoglycemic events [ Time Frame: Baseline to Week 16 ]
  • Percentage of patients with adverse events [ Time Frame: Baseline to Week 16 ]
  • Percentage of patients with serious adverse events [ Time Frame: Baseline to Week 16 ]
  • Assessment of satisfaction with diabetes treatment using Diabetes Treatment Satisfaction Questionnaire [ Time Frame: Baseline to Week 16 ]
  • Assessment of fear of hypoglycemia using Hypoglycemia Fear Survey-II [ Time Frame: Baseline to Week 16 ]
  • Assessment of emotional well-being using WHO-5 well-being index [ Time Frame: Baseline to Week 16 ]
  • Assessment of diabetes-related emotional stress using Diabetes Distress Scale [ Time Frame: Baseline to Week 16 ]
  • Assessment of satisfaction with glucose monitoring using the Glucose Monitoring Satisfaction Survey [ Time Frame: Baseline to Week 16 ]
  • Assessment of device Ease of Use using Ease of Use questionnaire [ Time Frame: Baseline to Week 16 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of MyStar DoseCoach to Routine Titration in Adult Patients With Type 2 Diabetes Mellitus Using Toujeo
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Insulin glargine (U300)

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

    Other Name: HOE901
  • Device: MyStar DoseCoach
    Glucose meter
Study Arms  ICMJE
  • Experimental: 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).
    Interventions:
    • Drug: Insulin glargine (U300)
    • Device: MyStar DoseCoach
  • Active Comparator: 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).
    Intervention: Drug: Insulin glargine (U300)
Publications * 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. Erratum in: Diabetes Care. 2019 Aug;42(8):1604.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2016)
151
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2015)
148
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02585674
Other Study ID Numbers  ICMJE EFC13470
2014-004533-13 ( EudraCT Number )
U1111-1165-9001 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP