E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
To assess the efficacy, safety and adherence/satisfaction of MyStar DoseCoach |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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). |
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E.5 End points |
E.5.1 | Primary end point(s) |
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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Percentage of patients reaching fasting SMPG target range of 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 severe and/or confirmed
hypoglycemic events during the 16-week on-treatment period
Percentage of patients reaching laboratory FPG target range (90- 130
mg/dL) at Week 16 without severe hypoglycemia during the 16-week
on-treatment period
Mean FSMPG glucose change from baseline to Week 16 (mean of the last
5 readings recorded over the last 2 weeks)
Time to reach the first fasting SMPG target range of 90-130 mg/dL (5.0-
7.2 mmol/L)
Mean FPG glucose change from baseline to Week 16
Mean HbA1c change from baseline to Week 16
Percentage of patients reaching HbA1c of <7.5% and <7% at Week 16
Percentage of patients with hypoglycemic events
Number of hypoglycemic events
Percentage of patients with adverse events
Percentage of patients with serious adverse events
Assessment of satisfaction with diabetes treatment using Diabetes
Treatment Satisfaction Questionnaire)
Assessment of fear of hypoglycemia using Hypoglycemia Fear Survey-II
Assessment of emotional well-being using WHO-5 well-being index
Assessment of diabetes-related emotional stress using Diabetes Distress
Scale
Assessment of satisfaction with glucose monitoring using the
Glucose Monitoring Satisfaction Survey
Assessment of device Ease of Use using Ease of Use questionnaire
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline to Week 16 for all secondary endpoints, except :
Percentage of patients reaching HbA1c of <7.5% and <7% at Week 16
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
In addition efficacy and safety of the MyStar DoseCoach versus routine titration in patients with T2DM treated with HOE901-U300 are assessed as well. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Dose adjustment with MyStar DoseCoach(dose helper function of the device) versus routine titration |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 23 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Austria |
Germany |
Switzerland |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |