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

NCT ID: NCT02715258

Last Updated: 2021-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-04-30

Brief 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).

Detailed Description

This was a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of once daily oral administration of bexagliflozin tablets, 20 mg or placebo tablets, in male and female subjects with T2DM who were treatment-naïve or previously treated with 1 oral hypoglycemic agent (OHA).

Prospective subjects being treated with one OHA were eligible if they had an HbA1c between 6.5% and 10.0% and were willing to complete a 6-week washout. Individuals taking thiazolidinediones were not eligible for the study. All eligible subjects were to start a 2-week placebo run-in period. Subjects who missed no more than 1 dose of the run-in medication, had fasting blood glucose values ≥ 250 mg/dL on no more than two consecutive days, and had an HbA1c level between 7.0% and 10.5% and a fasting glucose level < 250 mg/dL after the run-in period were eligible for randomization.

Two hundred and ten (210) subjects were planned to be randomly assigned to receive oral bexagliflozin tablets, 20 mg or placebo, in a 2:1 ratio once daily for 24 weeks. Subjects with uncontrolled hyperglycemia based on blood glucose levels could receive additional approved anti-diabetic medications. Treatment group assignment at the start of the treatment period was stratified by baseline HbA1c level and background anti-diabetes treatment status (treatment naïve or not).

Each subject was contacted by telephone at week 2 and was instructed to return to the clinic at weeks 6, 12, 18, and 24 for efficacy assessment and safety monitoring. Subjects returned to the clinic for a follow-up visit at week 26 or 2 weeks after the last dose of investigational product if the subject terminated prior to week 24.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bexagliflozin tablets, 20 mg

Each subject will self-administer bexagliflozin tablets once daily for 24 weeks.

Group Type: ACTIVE_COMPARATOR

Bexagliflozin

Intervention Type: DRUG

tablets containing 20 mg bexagliflozin

Placebo tablets

Each subject will self-administer placebo (inactive tablet) once daily for 24 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

tablets matching the appearance of bexagliflozin tablets

Interventions

Bexagliflozin

tablets containing 20 mg bexagliflozin

Intervention Type: DRUG

Placebo

tablets matching the appearance of bexagliflozin tablets

Intervention Type: DRUG

Other Intervention Names

EGT0001442

Eligibility Criteria

Exclusion Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theracos

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

J. Paul Lock, MD

Role: STUDY_DIRECTOR

Theracos

Locations

Research Site

Canoga Park, California, United States

Research Site

Chino, California, United States

Research Site

Huntington Park, California, United States

Research Site

Los Angeles, California, United States

Research Site

San Diego, California, United States

Research Site

Fort Lauderdale, Florida, United States

Research Site

Hialeah, Florida, United States

Research Site

Miami Lakes, Florida, United States

Research Site

Orlando, Florida, United States

Research Site

Port Orange, Florida, United States

Research Site

Trenton, New Jersey, United States

Research Site

Calabash, North Carolina, United States

Research Site

Morehead City, North Carolina, United States

Research Site

Munroe Falls, Ohio, United States

Research Site

Portland, Oregon, United States

Research Site

North Myrtle Beach, South Carolina, United States

Research Site

DeSoto, Texas, United States

Research Site

Fort Worth, Texas, United States

Research Site

Vancouver, British Columbia, Canada

Research Site

Newmarket, Ontario, Canada

Research Site 2

Toronto, Ontario, Canada

Research Site 1

Toronto, Ontario, Canada

Research Site

Pointe-Claire, Quebec, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

THR-1442-C-450

Identifier Type: -

Identifier Source: org_study_id