Safety and Efficacy of Bexagliflozin Compared to Sitagliptin as Add-on Therapy to Metformin in Type 2 Diabetes Subjects

Each subject was required to meet the following criteria at the time of enrollment to be eligible for the study:

• To have been male or female adults ≥ 18 years of age.
• To have been negative on the urine pregnancy test and agreed to abstain from coitus or use contraception during the entire study if a subject was female of childbearing potential.
• To have had a diagnosis of T2DM with HbA1c levels between 7.0% and 11% (inclusive) at the time of screening.
• To have been treated with a stable dose of ≥ 1500 mg/day metformin only along with diet and exercise counseling for at least 8 weeks at the time of screening.
• To have had a BMI ≤ 45 kg per m2 at the time of screening.
• To have been taking stable doses of treatment for dyslipidemia and/or hypertension for 30 days if applicable.
• To have been willing and able to return for all clinic visits and to complete all study-required procedures.
• To have adhered to the investigational product administration requirements as evidenced by missing no more than 1 day of run-in medications.

Potential subjects who exhibited any of the following characteristics were to be excluded from the study:

• Diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young (MODY)
• Hemoglobinopathy that affected HbA1c measurement
• Any contraindication to the safe use of DPP-4 therapy or sitagliptin, including known hypersensitivity reaction
• History of pancreatitis
• Genitourinary tract infection within 6 weeks of screening or history of ≥ 3 genitourinary infections requiring treatment within 6 months from the time of screening
• Cancer, active or in remission, for 500 mg dL-1 at Visit V1
• Evidence of abnormal liver function tests (total bilirubin or alkaline phosphatase > 1.5 x upper limit of normal (ULN) with the exception of isolated Gilbert's syndrome); or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 x ULN
• Estimated GFR, as calculated by the modification of diet in renal disease study equation (MDRD), 160 mm Hg or diastolic BP > 95 mm Hg) at Visit V1
• Life expectancy 1500 mg g-1 at the time of screening).
• Any condition, disease, disorder or clinically relevant abnormality that could have jeopardized the subject's appropriate participation in this study or obscure the effects of treatment
• Female subjects who were pregnant or nursing
• Two or more consecutive SMBG measures ≥ 250 mg dL-1 (13.9 mmol L-1) prior to randomization accompanied by clinical signs or symptoms of hyperglycemia prior to randomization, including weight loss, blurred vision, increased thirst increased urination, or fatigue