Clinical trial NCT02926950 (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: sotagliflozin (sar439954), placebo, metformin
SMILES: CCOC1=CC=C(CC2=CC(=CC=C2Cl)[C@@H]2O[C@H](SC)[C@@H](O)[C@H](O)[C@H]2O)C=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CSCC[C@H](N)C(O)=O
Eligibility criteria:

        Inclusion criteria :

          -  Patients with Type 2 Diabetes currently treated with diet and exercise and on
             metformin at a stable dose ≥1500 mg/day for at least 12 weeks. However, patients on
             metformin at a dose <1500 mg/day at the time of enrollment (stable dose for at least
             12 weeks before enrollment) may be eligible for screening if documentation of lack of
             tolerance of a metformin dose ≥1500 mg/day can be provided.

          -  Signed written informed consent.

        Exclusion criteria:

          -  Age <18 years at Screening or < legal age of majority, whichever is greater.

          -  Type 1 diabetes mellitus.

          -  Body Mass Index (BMI) ≤20 or >45 kg/m2 at Screening

          -  Hemoglobin A1c <7% or >10% via central laboratory test at screening.

          -  Fasting plasma glucose (FPG) >15 mmol/L (270 mg/dL) measured by the central laboratory
             at screening (Visit 1) and confirmed by a repeat test (>15 mmol/L [270 mg/dL]) before
             randomization.

          -  Women of childbearing potential not willing to use highly effective method(s) of birth
             control or who are unwilling or unable to be tested for pregnancy during the study.

          -  Treated with an antidiabetic pharmacological regimen other than metformin ≥1500 mg per
             day (or maximum tolerated dose) within the 12 weeks preceding the Screening Visit.

          -  Previous use of any types of insulin for >1 month (at any time, aside from pregnancy
             for treatment of gestational diabetes).

          -  History of prior gastric surgical procedure, including gastric banding, within 3 years
             before the Screening Visit.

          -  History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior
             to the Screening Visit.

          -  Mean of 3 separate blood pressure measurements >180 mmHg (SBP) or >100 mmHg (diastolic
             blood pressure [DBP]).

          -  History of hypertensive urgency or emergency within 12 weeks prior to Screening.

          -  Patients with severe anemia, severe cardiovascular (including congestive heart failure
             New York Heart Association [NYHA] IV), respiratory, hepatic, neurological,
             psychiatric, or active malignant tumor or other major systemic disease or patients
             with short life expectancy making implementation of the protocol or interpretation of
             the study results difficult.

          -  Aspartate aminotransferase and/or alanine aminotransferase: >3 times the upper limit
             of the normal laboratory range.

          -  Total bilirubin: >1.5 times the upper limit of the normal laboratory range (except in
             case of Gilbert's syndrome).

          -  Use of systemic glucocorticoids (excluding topical or ophthalmic application or
             inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening
             Visit.

          -  Patient who has taken other investigational drugs or prohibited therapy for this study
             within 12 weeks or 5 half-lives from screening or randomization, whichever is longer.

          -  Pregnant (confirmed by serum pregnancy test at Screening) or breastfeeding women.

          -  Patient is unwilling or unable to perform self-monitoring of blood glucose (SMBG),
             complete the patient diary, or comply with study visits and other study procedures as
             required per protocol.

          -  Contraindication to metformin as per local labeling.

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.