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

You may be eligible if

• The subjects were required to meet the following criteria at the time of enrollment to be eligible for the study:
• 2. a) Had a history of T2DM with an HbA1c level of ≥ 7.5% and ≤ 10.5% at screening, or b) Had a history of T2DM with an HbA1c level of \>10.5% and ≤ 12.0% at screening
• 3. Had been prescribed a stable dose of metformin (≥1500 mg per day in the US or ≥ 1000 mg per day in Japan) as their sole anti-diabetic medication
• 4. Had a body mass index (BMI) ≤ 45 kg m-2
• 5. Had been able to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines
• 6. Had no recent changes to their medications for hypertension or hyperlipidemia (if applicable)
• 7. Had the ability to regularly self-administer medication, as evidenced by consumption of all, or at worst one less than all, doses of run-in medication prior to randomization
• Subjects who met any of the following criteria were to be excluded from the study:
• 1. Had a diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young
• 2. Were pregnant or breastfeeding
• 3. Had one or more hemoglobin alleles that affect HbA1c measurement
• 4. Had a history of genitourinary tract infection (e.g., UTI, GMI, vaginitis, balanitis) within 6 weeks of screening or a history of ≥ 3 genitourinary infections requiring treatment within 6 months of screening
• 5. Had an estimated glomerular filtration rate (eGFR), as calculated by the modification of diet in renal disease study equation (MDRD), \< 60 mL min-1 per 1.73 m2
• 6. Had a sitting systolic blood pressure \>180 mmHg or a sitting diastolic blood pressure \> 110 mmHg at screening
• 7. Had exposure to hypoglycemic agent(s) other than metformin during the 8 weeks prior to screening
• 8. Had a history of illicit drug use or alcohol abuse in the past 2 years
• 9. Had a life expectancy \< 2 years
• 10. Had a diagnosis of New York Heart Association (NYHA) Class IV heart failure within 3 months of screening
• 11. Had experienced an MI, unstable angina, stroke, or hospitalization for heart failure within 3 months of screening
• 12. Had exposure to an investigational drug within 30 days
• 13. Had a previous exposure to bexagliflozin or EGT0001474
• 14. Had a history of SGLT2 inhibitor treatment
• 15. Were participating in another interventional trial
• 16. Were not able to comply with the study scheduled visits
• 17. Had any condition, disease, disorder, or clinically relevant abnormality that, in the opinion of the primary investigator, would jeopardize the subject's appropriate participation in this study or obscure the effects of treatment
• 18. Had an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 × ULN or total bilirubin ≥ 1.5 × ULN at screening