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

NCT02715258 | Completed Phase 3 Results DMC

• 1 other identifier: THR-1442-C-450
• Study Type: interventional
• Target: 210
• Locations: 2 countries
• Sites: 23

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).

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c From Baseline at Week 24

  Glycated hemoglobin A1c (%) was measured using an HPLC method in the laboratories that had completed NGSP Level I laboratory certification and were traceable to the Diabetes Control and Complications Trial (DCCT) reference method.

  24 weeks

Secondary Outcomes (2)

• Change in Systolic Blood Pressure (SBP) From Baseline at Week 24

  24 weeks

• Change in Body Weight From Baseline at Week 24 in Subjects With a BMI ≥ 25 Kg/m2

  24 weeks

Other Outcomes (3)

• Change From Baseline in Fasting Plasma Glucose (FPG) Over Time

  24 weeks

• Change From Baseline of HbA1c From Baseline Over Time

  24 weeks

• Proportion of Subjects Who Achieve an HbA1c < 7%

  Up to 24 weeks

Study Arms (2)

Bexagliflozin tablets, 20 mg

ACTIVE COMPARATOR

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

Drug: Bexagliflozin

Placebo tablets

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Bexagliflozin DRUG

tablets containing 20 mg bexagliflozin

Also known as: EGT0001442

Bexagliflozin tablets, 20 mg

Placebo DRUG

tablets matching the appearance of bexagliflozin tablets

Placebo tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Theracos: lead

Study Sites (23)

Research Site

Canoga Park, California, 91303, United States

Location

Research Site

Chino, California, 91710, United States

Location

Research Site

Huntington Park, California, 90255, United States

Location

Research Site

Los Angeles, California, 90057, United States

Location

Research Site

San Diego, California, 92103, United States

Location

Research Site

Fort Lauderdale, Florida, 33316, United States

Location

Research Site

Hialeah, Florida, 33012, United States

Location

Research Site

Miami Lakes, Florida, 33016, United States

Location

Research Site

Orlando, Florida, 32806, United States

Location

Research Site

Port Orange, Florida, 32127, United States

Location

Research Site

Trenton, New Jersey, 08611, United States

Location

Research Site

Calabash, North Carolina, 28467, United States

Location

Research Site

Morehead City, North Carolina, 28557, United States

Location

Research Site

Munroe Falls, Ohio, 44262, United States

Location

Research Site

Portland, Oregon, 97239, United States

Location

Research Site

North Myrtle Beach, South Carolina, 29582, United States

Location

Research Site

DeSoto, Texas, 75115, United States

Location

Research Site

Fort Worth, Texas, 76164, United States

Location

Research Site

Vancouver, British Columbia, V6J 1S3, Canada

Location

Research Site

Newmarket, Ontario, L3Y 5G8, Canada

Location

Research Site 2

Toronto, Ontario, M9V 4B4, Canada

Location

Research Site 1

Toronto, Ontario, M9W 4L6, Canada

Location

Research Site

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

bexagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Albert Collinson
• Organization: Theracos Sub, LLC

acollinson@theracos.com

(508) 630-2129

Study Officials

• J. Paul Lock, MD

  Theracos

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: March 22, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: June 28, 2021
• Results First Posted: April 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5); US (18)