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

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Insulin glargine (U300); Device: 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: Interventional
• Enrollment (Actual): 151
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10115
    • Investigational Site Number 276002
  • Dresden, Germany, 01307
    • Investigational Site Number 276001
  • Essen, Germany, 45359
    • Investigational Site Number 276007
  • Heidelberg, Germany, 69115
    • Investigational Site Number 276003
  • Künzing, Germany, 94550
    • Investigational Site Number 276010
  • Neumünster, Germany, 24534
    • Investigational Site Number 276005
  • Oldenburg In Holstein, Germany, 23758
    • Investigational Site Number 276004
  • Pirna, Germany, 01796
    • Investigational Site Number 276006
  • Sulzbach-Rosenberg, Germany, 92237
    • Investigational Site Number 276008
• United Kingdom
  • Airdrie, United Kingdom, ML6 OJS
    • Investigational Site Number 826003
  • Belfast, United Kingdom, BT12 6BA
    • Investigational Site Number 826002
  • Bristol, United Kingdom, BS10 5NB
    • Investigational Site Number 826011
  • Chester, United Kingdom, CH2 1UL
    • Investigational Site Number 826001
  • Dumfries, United Kingdom, DG1 4AP
    • Investigational Site Number 826006
  • East Kilbride, United Kingdom, G75 8RG
    • Investigational Site Number 826008
  • Larbert, United Kingdom, FK5 4WR
    • Investigational Site Number 826005
  • Londonderry, United Kingdom, BT47 6SB
    • Investigational Site Number 826010
  • Swansea, United Kingdom, SA6 6NL
    • Investigational Site Number 826009
  • Taunton, United Kingdom, TA1 5DA
    • Investigational Site Number 826007

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Drug: Insulin glargine (U300); Pharmaceutical form: solution for injection Route of administration: subcutaneous; Other Names: HOE901; Device: MyStar DoseCoach; Glucose meter
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).	Drug: Insulin glargine (U300); Pharmaceutical form: solution for injection Route of administration: subcutaneous; Other Names: HOE901

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Mean HbA1c change from baseline	Baseline to Week 16
Percentage of patients reaching HbA1c of <7.5% and <7%	Week 16
Percentage of patients with hypoglycemic events	Baseline to Week 16
Number of hypoglycemic events	Baseline to Week 16
Percentage of patients with adverse events	Baseline to Week 16
Percentage of patients with serious adverse events	Baseline to Week 16
Assessment of satisfaction with diabetes treatment using Diabetes Treatment Satisfaction Questionnaire	Baseline to Week 16
Assessment of fear of hypoglycemia using Hypoglycemia Fear Survey-II	Baseline to Week 16
Assessment of emotional well-being using WHO-5 well-being index	Baseline to Week 16
Assessment of diabetes-related emotional stress using Diabetes Distress Scale	Baseline to Week 16
Assessment of satisfaction with glucose monitoring using the Glucose Monitoring Satisfaction Survey	Baseline to Week 16
Assessment of device Ease of Use using Ease of Use questionnaire	Baseline to Week 16

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: October 22, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimate): October 23, 2015

Study Record Updates

• Last Update Posted (Estimate): December 6, 2016
• Last Update Submitted That Met QC Criteria: December 5, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Glargine
• Other Study ID Numbers: EFC13470; 2014-004533-13 (EudraCT Number); U1111-1165-9001 (Other Identifier: UTN)