Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment

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 non-pregnant female ≥ 20 years of age. Women of childbearing potential were required to agree to use contraception throughout the study to avoid any possible pregnancy. Females who were surgically sterile (hysterectomy, oophorectomy) or postmenopausal (absence of menses for greater than 12 months and age > 45 years) were eligible if they tested negative on the urine pregnancy test.
• To have had a diagnosis of T2DM with an HbA1c between 7.0 and 10.5% (inclusive) at the time of screening.
• To have been treatment naïve or to have been treated with a stable regimen of anti-diabetic medications. At the time of screening, the doses and frequency of all anti-diabetic medications were to have been stable for 8 weeks.
• To have had an eGFR ≥ 30 and 1.5 × upper limit of normal (ULN) with the exception of isolated Gilbert's syndrome); or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × ULN
• A history of MI, stroke or hospitalization for heart failure, or hospitalization for unstable angina in the prior 3 months
• Evidence of NYHA class IV heart failure at screening or randomization
• A history of taking an SGLT2 inhibitor within 3 months of screening
• Any condition, disease, disorder, or clinically relevant laboratory abnormality that, in the opinion of the PI, would jeopardize the subject's appropriate participation in this study or obscure the effects of treatment
• A current status of pregnancy or breastfeeding
• A current status of renal replacement therapy (peritoneal or hemodialysis) or a history of renal transplantation
• A corrected serum calcium 170 mm Hg or diastolic blood pressure >110 mm Hg)
• Participation in another interventional trial or exposure to an investigational drug within 30 days or 7 half-lives of screening, whichever was longer
• Previous exposure to bexagliflozin or EGT0001474
• Evidence of having skipped dosing more than once during the run-in period
• A fasting blood glucose value during the run-in period ≥ 250 mg dL-1 (13.9 mmol L-1) associated with severe clinical signs or symptoms of hyperglycemia
• Any episode of symptomatic hypoglycemia during the run-in period in which symptoms were severe
• An inability to comprehend or unwillingness to provide written informed consent in accordance with institutional and regulatory guidelines