Clinical trial NCT02585674 (phase 3, status: completed)
Conditions: type 2 diabetes mellitus
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: insulin glargine (u300)
SMILES: [Na+].[Na+].[O-]P([O-])(F)=O
Eligibility criteria:

        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.