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

Inclusion criteria :

• Patients with type 2 diabetes mellitus diagnosed at least one year before thescreening visit.

• Patients who are insulin naïve (and considered by the investigator to be appropriatecandidates for basal insulin therapy), or treated with basal insulin as their onlyinsulin.

• 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 isotherwise contraindicated (in the opinion of the Investigator).

• Conditions/situations that are contraindications or off-label use according to Summaryof Product Characteristics (SmPCs) of Oral Anti-Diabetes Drugs (OADs) and/or GLP-1receptor agonists when applicable (prescribed), or insulin glargine and as defined inthe national product label.

• Patients not on stable dose of glucose lowering therapy including OADs, GLP-1 receptoragonists, or basal insulin therapy, for the last 3 months (stable basal insulintherapy defined as maximum change in insulin dose of +/- 20%).

• Patients using mealtime insulin (short acting analogue, human regular insulin, orpremix 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) forone week or more within 90 days prior to the time of screening.

• Unable to meet specific protocol requirements (eg, inability to perform blood glucosemeasurements, manage their own insulin glargine administration, or deemed unlikely tosafely 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 wouldaffect a patient's ability to participate in the study, including the inability tounderstand study requirements or to give complete information about adverse symptoms.

• Conditions/situations such as:

• Patients with conditions/concomitant diseases precluding their safe participation inthis study (eg, active malignant tumor, major systemic diseases, presence ofclinically significant diabetic retinopathy or presence of macular edema likely torequire treatment within the study period, etc.),

• Patients unable to fully understand study documents and to complete them. Patients whohave a caregiver together with whom they can fulfill all study requirements areeligible,

• Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist,study coordinator, other staff or relative thereof directly involved in the conduct ofthe protocol.

• Within the last 3 months prior to screening: history of myocardial infarction,unstable angina, acute coronary syndrome, revascularization procedure, or strokerequiring hospitalization.

• Severe or uncontrolled Congestive Heart Failure (New York Heart Association [NYHA]functional classification III and IV); or inadequately controlled hypertension at thetime of screening with a resting systolic or diastolic blood pressure >180 mmHg or >95mmHg, respectively.

• Pregnant or breast-feeding women or women who intend to become pregnant during thestudy period as glycemic control may be unstable and insulin doses may be variableduring this period.

• Women of childbearing potential (premenopausal, not surgically sterile for at least 3months prior to the time of screening) must use an effective contraceptive methodthroughout the study. Effective methods of contraception include barrier methods (inconjunction 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'spotential participation in a clinical trial.