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

NCT02585674 | Completed Phase 3

• 3 other identifiers: EFC134702014-004533-13U1111-1165-9001
• Study Type: interventional
• Target: 151
• Locations: 2 countries
• Sites: 19

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (17)

• 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

• Percentage of patients reaching laboratory FPG target range (90-130 mg/dL) without severe hypoglycemia

  Baseline to Week 16

• Mean FSMPG glucose change from baseline (mean of the last 5 readings recorded over the last 2 weeks)

  Baseline to Week 16

• Time to reach the first fasting SMPG target range of 90-130 mg/dL (5.0-7.2 mmol/L)

  Baseline to Week 16

• Mean FPG glucose change from baseline

  Baseline to Week 16

Study Arms (2)

MyStar DoseCoach

EXPERIMENTAL

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).

Drug: Insulin glargine (U300); Device: MyStar DoseCoach

Routine Titration

ACTIVE COMPARATOR

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).

Drug: Insulin glargine (U300)

Interventions

Insulin glargine (U300) DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Also known as: HOE901

MyStar DoseCoach; Routine Titration

MyStar DoseCoach DEVICE

Glucose meter

MyStar DoseCoach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Sanofi: lead

Study Sites (19)

Investigational Site Number 276002

Berlin, 10115, Germany

Location

Investigational Site Number 276001

Dresden, 01307, Germany

Location

Investigational Site Number 276007

Essen, 45359, Germany

Location

Investigational Site Number 276003

Heidelberg, 69115, Germany

Location

Investigational Site Number 276010

Künzing, 94550, Germany

Location

Investigational Site Number 276005

Neumünster, 24534, Germany

Location

Investigational Site Number 276004

Oldenburg in Holstein, 23758, Germany

Location

Investigational Site Number 276006

Pirna, 01796, Germany

Location

Investigational Site Number 276008

Sulzbach-Rosenberg, 92237, Germany

Location

Investigational Site Number 826003

Airdrie, ML6 OJS, United Kingdom

Location

Investigational Site Number 826002

Belfast, BT12 6BA, United Kingdom

Location

Investigational Site Number 826011

Bristol, BS10 5NB, United Kingdom

Location

Investigational Site Number 826001

Chester, CH2 1UL, United Kingdom

Location

Investigational Site Number 826006

Dumfries, DG1 4AP, United Kingdom

Location

Investigational Site Number 826008

East Kilbride, G75 8RG, United Kingdom

Location

Investigational Site Number 826005

Larbert, FK5 4WR, United Kingdom

Location

Investigational Site Number 826010

Londonderry, BT47 6SB, United Kingdom

Location

Investigational Site Number 826009

Swansea, SA6 6NL, United Kingdom

Location

Investigational Site Number 826007

Taunton, TA1 5DA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29895556 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 23, 2015
• Study Start: December 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 6, 2016

Record last verified: 2016-12

Locations

GB (10); DE (9)