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Type 2 Diabetes MellitusPhase 3AUTOMATIXNCT02585674

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

A Phase 3 study testing Insulin glargine (U300) and MyStar DoseCoach in people with Type 2 Diabetes Mellitus, run by Sanofi at 19 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Insulin glargine (U300) and MyStar DoseCoach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
19 sitesin 2 countries
Study dates
Dec 2015to Nov 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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.

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

United Kingdom10 sites

  • Investigational Site Number 826003

    Airdrie, ML6 OJS

  • Investigational Site Number 826002

    Belfast, BT12 6BA

  • Investigational Site Number 826011

    Bristol, BS10 5NB

  • Investigational Site Number 826001

    Chester, CH2 1UL

  • Investigational Site Number 826006

    Dumfries, DG1 4AP

  • Investigational Site Number 826008

    East Kilbride, G75 8RG

  • Investigational Site Number 826005

    Larbert, FK5 4WR

  • Investigational Site Number 826010

    Londonderry, BT47 6SB

  • Investigational Site Number 826009

    Swansea, SA6 6NL

  • Investigational Site Number 826007

    Taunton, TA1 5DA

Other trials in United Kingdom

Germany9 sites

  • Investigational Site Number 276002

    Berlin, 10115

  • Investigational Site Number 276001

    Dresden, 01307

  • Investigational Site Number 276007

    Essen, 45359

  • Investigational Site Number 276003

    Heidelberg, 69115

  • Investigational Site Number 276010

    Künzing, 94550

  • Investigational Site Number 276005

    Neumünster, 24534

  • Investigational Site Number 276004

    Oldenburg in Holstein, 23758

  • Investigational Site Number 276006

    Pirna, 01796

  • Investigational Site Number 276008

    Sulzbach-Rosenberg, 92237

Other trials in Germany

About this study

Official title: 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

Read the 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.

Being tested
Insulin glargine (U300), MyStar DoseCoach
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin glargine (U300)Drug

    Also called HOE901

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

  • MyStar DoseCoachDevice

    Glucose meter

Study groups in NCT02585674
Study groupRoleWhat they receive
MyStar DoseCoachExperimentalMyStar 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).
Receives: Drug: Insulin glargine (U300); Device: MyStar DoseCoach
Routine TitrationActive comparatorRoutine 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).
Receives: Drug: Insulin glargine (U300)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline to Week 16

Secondary outcomes (17)

  1. 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

    Measured: Baseline to Week 16

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

    Measured: Baseline to Week 16

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

    Measured: Baseline to Week 16

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

    Measured: Baseline to Week 16

  5. Mean FPG glucose change from baseline

    Measured: Baseline to Week 16

  6. Mean HbA1c change from baseline

    Measured: Baseline to Week 16

  7. Percentage of patients reaching HbA1c of <7.5% and <7%

    Measured: Week 16

  8. Percentage of patients with hypoglycemic events

    Measured: Baseline to Week 16

  9. Number of hypoglycemic events

    Measured: Baseline to Week 16

  10. Percentage of patients with adverse events

    Measured: Baseline to Week 16

  11. Percentage of patients with serious adverse events

    Measured: Baseline to Week 16

  12. Assessment of satisfaction with diabetes treatment using Diabetes Treatment Satisfaction Questionnaire

    Measured: Baseline to Week 16

  13. Assessment of fear of hypoglycemia using Hypoglycemia Fear Survey-II

    Measured: Baseline to Week 16

  14. Assessment of emotional well-being using WHO-5 well-being index

    Measured: Baseline to Week 16

  15. Assessment of diabetes-related emotional stress using Diabetes Distress Scale

    Measured: Baseline to Week 16

  16. Assessment of satisfaction with glucose monitoring using the Glucose Monitoring Satisfaction Survey

    Measured: Baseline to Week 16

  17. Assessment of device Ease of Use using Ease of Use questionnaire

    Measured: Baseline to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionNov 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02585674
Sponsor's protocol ID
EFC13470
Other IDs
2014-004533-13, U1111-1165-9001, 2014
Acronym
AUTOMATIX
Status last verified
Dec 2016
First submitted
22 Oct 2015
Last updated
6 Dec 2016
Results posted
No
Data monitoring committee
No

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.

    PubMed 29895556

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin glargine (U300) and MyStar DoseCoach in people with Type 2 Diabetes Mellitus, run by Sanofi at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United Kingdom, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02585674, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.

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