Type 2 Diabetes Mellitus
Conditions
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.
Interventions
Pharmaceutical form: solution for injection Route of administration: subcutaneous
DEVICEMyStar DoseCoach
Glucose meter
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Assessment of fear of hypoglycemia using Hypoglycemia Fear Survey-II | 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 |
| 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 |
| Mean FPG glucose change from baseline | Baseline to Week 16 |
Countries
Germany, United Kingdom
Outcome results
None listed