A Dose Range Finding Study to Evaluate the Effect of Bexagliflozin Tablets in Subjects With Type 2 Diabetes Mellitus

You may be eligible if

• The following subjects were eligible for randomization:
• 1. men or women ≥ 20 years of age at screening. Women of childbearing potential must test negative by urine pregnancy test.
• 2. were treatment naïve or taking one oral anti-diabetic medication in combination with diet and exercise
• 3. were diagnosed with T2DM with HbA1c levels at screening between 7.0% and 8.5% (inclusive) if treatment naïve or with HbA1c levels between 6.5 and 8.5% (inclusive) if on one oral anti-diabetic medication
• 4. had a body mass index (BMI) ≤ 40 kg/m2
• 5. were taking stable doses of medication for hypertension or hyperlipidemia that has not changed for at least 30 days prior to screening (if applicable)
• 6. were able to comprehend the study participation requirements and willing to provide written informed consent in accordance with institutional and regulatory guidelines
• 7. were able to maintain adequate glycemic control at the run-in visit (for subjects who complete the washout)
• 8. had an HbA1c between 7.0 and 8.5% (inclusive) prior to randomization (day -3 to -5)
• 9. were capable of adhering to the investigational product administration requirements as evidenced by omission of no more than one dose of run-in medication
• Subjects who exhibited any of the following characteristics were to be ineligible for randomization:
• 1. Diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young
• 2. Used parenteral therapy for treatment of diabetes
• 3. Pregnancy or current breastfeeding status
• 4. Hemoglobinopathy or carrier status for hemoglobin alleles that affect HbA1c measurement
• 5. Genitourinary tract infection within 6 weeks of screening or history of ≥3 genitourinary infections requiring treatment within 6 months of screening
• 6. Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 at screening.
• 7. Uncontrolled hypertension at screening
• 8. A positive result on hepatitis B surface antigen, hepatitis C, or positive result from screen for drugs of abuse
• 9. History of human immunodeficiency virus infection
• 10. Life expectancy \< 2 years
• 11. History of New York Heart Association Class 4 heart failure within 3 months of screening
• 12. History of myocardial infarction, unstable angina, stroke, or hospitalization for heart failure within 3 months of screening
• 13. History of treatment with an investigational drug within 30 days or within 7 half lives of the investigational drug, whichever is longer
• 14. Previous treatment with bexagliflozin
• 15. Had taken or within 6 months of taking any Sodium Glucose Transporter 2 (SGLT2) inhibitors prior to screening
• 16. Participation of another interventional trial
• 17. Not able to comply with the study scheduled visits
• 18. Affected by any condition, disease, disorder, or clinically relevant abnormality that, in the opinion of the investigator, would jeopardize the subject's appropriate participation in this study.
• 19. Liver function tests resulting in Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 2.5 x upper limit of normal (ULN) or total bilirubin ≥ 1.5 x ULN, with the exception of isolated Gilbert's syndrome ,at screening
• 20. Exhibited fasting plasma glucose ≥ 250 mg/dL (13.9 mmol/L) on two or more consecutive days prior to randomization or exhibited severe clinical signs or symptoms of hyperglycemia during the washout or run-in periods, including weight loss, blurred vision, increased thirst, or increased urination, or fatigue
• 21. Fasting Plasma Glucose ≥ 250 mg/dL at randomization
• 22. Prior renal transplantation or evidence of nephrotic syndrome, defined as a urine albumin-to-creatinine ratio (UACR) \> 2000 mg/g at screening