Safety and Efficacy of Bexagliflozin as Monotherapy in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theracos
• Treatments: Bexagliflozin

Criteria

The study population included:

1. Male or female adult subjects ≥ 18 years of age at screening

2. Subjects who were treatment naïve or receiving 1 OHA in combination with diet and exercise

3. Subjects with a diagnosis of T2DM

4. Subjects with HbA1c levels at screening between 7.0% and 10.5% (inclusive) if treatment-naïve or with HbA1c levels between 6.5 and 10.0% (inclusive) if on 1 oral anti diabetic agent

5. Subjects with a BMI ≤ 45 kg/m2

6. Subjects whose doses of medications for hypertension or hyperlipidemia (if applicable) had not changed for at least 30 days prior to screening

7. Subjects who were willing and able to return for all clinic visits and to complete all study required procedures

8. Female subjects of childbearing potential who were willing to use an adequate method of contraception and not become pregnant for the duration of the study.

9. Subjects who maintained glycemic control throughout washout, if applicable.

10. Subjects who had HbA1c levels between 7.0 and 10.5% prior to randomization

11. Subjects who had been compliant in investigational product administration by missing no more than 1 dose of run-in medication

Subjects who met any of the following criteria were excluded from the study:

1. A diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young

2. Use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor agonist therapy) or thiazolidinedione class drugs at the time of screening

3. Female subjects who were pregnant or breastfeeding

4. Hemoglobinopathy or carrier status for hemoglobin alleles that affected HbA1c measurement

5. Genitourinary tract infection (e.g., UTI, GMI, vaginitis, balanitis) within 6 weeks of screening or history of ≥ 3 genitourinary infections requiring treatment within 6 months from screening

6. Estimated glomerular filtration rate (eGFR), as calculated by the modification of diet in renal disease study equation (MDRD), < 60 mL/min/1.73 m2 at screening

7. Uncontrolled hypertension defined as a sitting systolic blood pressure >160 mm Hg or diastolic blood pressure > 95 mm Hg at screening

8. A positive result for hepatitis B surface antigen (HBsAg) or hepatitis C (HCV)

9. History of alcohol or illicit drug abuse in the past 2 years

10. Known human immunodeficiency virus (HIV) positive based on medical history

11. Life expectancy < 2 years

12. New York Heart Association (NYHA) Class IV heart failure within 3 months of screening

13. MI, unstable angina, stroke, or hospitalization for heart failure within 3 months of screening

14. Treatment with an investigational drug within 30 days or within 7 half-lives of the investigational drug, whichever was longer

15. Previous treatment with bexagliflozin or EGT0001474

16. Use of any SGLT2 inhibitors, either at the time of screening or in the prior 3 months

17. Currently participating in another interventional trial

18. Not able to comply with the study scheduled visits

19. 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

20. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 x ULN or total bilirubin ≥ 1.5 x upper limit of normal (ULN) with the exception of isolated Gilbert's syndrome at screening

21. Two or more consecutive FPG measures ≥ 250 mg/dL (13.9 mmol/L) prior to randomization or 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

22. At last visit prior to randomization, FPG level ≥ 250 mg/dL

23. Prior renal transplantation or evidence of nephrotic syndrome (defined as a urine albumin-to-creatinine ratio (UACR) > 2000 mg/g at screening).