Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects
A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of Bexagliflozin Versus Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control by Metformin
1 other identifier
interventional
426
4 countries
45
Brief Summary
The purpose of this study is to investigate the effect of bexagliflozin compared to glimepiride as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with type 2 diabetes mellitus (T2DM).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes-mellitus
Started Aug 2016
Longer than P75 for phase_3 type-2-diabetes-mellitus
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2016
CompletedFirst Posted
Study publicly available on registry
May 11, 2016
CompletedStudy Start
First participant enrolled
August 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2019
CompletedResults Posted
Study results publicly available
May 27, 2021
CompletedMay 27, 2021
May 1, 2021
2.8 years
May 3, 2016
March 25, 2021
May 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in HbA1c at Week 60
The primary objective is to demonstrate that bexagliflozin is non-inferior to glimepiride by evaluating the treatment effect on HbA1c reduction at week 60 in subjects whose T2DM is inadequately controlled by metformin. The least square mean (LSM) change from baseline to Week 60 was analyzed using a mixed model repeated measures (MMRM) analysis of covariance model (ANCOVA).
Baseline and Week 60
Secondary Outcomes (4)
Change From Baseline in Body Weight at Week 60 for Subjects With Baseline BMI ≥ 25 kg/m2
Baseline and 60 weeks
Change From Baseline in Systolic Blood Pressure (SBP) at Week 60 for Subjects With Baseline SBP ≥ 140 mmHg
Baseline and 60 weeks
Difference in Proportion of Subjects With ≥ 1 Severe or Documented Symptomatic Hypoglycemia Events Over 96 Weeks
During the 96 week treatment period
Superiority of Bexagliflozin Over Glimepiride in HbA1c Reduction at Week 60.
Baseline to Week 60
Study Arms (2)
Bexagliflozin
ACTIVE COMPARATORSubjects will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for glimepiride daily for the duration of the study.
Glimepiride
ACTIVE COMPARATORSubjects will receive a glimepiride capsule, 2, 4 or 6 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for bexagliflozin for the duration of the study.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of T2DM
- Currently taking metformin or taking metformin and one additional oral medication for diabetes
- Body Mass Index (BMI) ≤ 45 kg/m2
- Stable dose of blood pressure or cholesterol medications (if applicable) for at least 30 days
You may not qualify if:
- Hypersensitivity or other contraindication to the safe use of sulfonylurea or glimepiride
- Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young
- Current use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor agonist therapy) or thiazolidinedione class drugs
- History of genitourinary tract infections
- Evidence of abnormal liver function
- Myocardial infarction, stroke or hospitalization for heart failure within 3 months of screening
- Prior kidney transplant or evidence of kidney problems
- Pregnant or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Theracoslead
Study Sites (45)
Research Site
Birmingham, Alabama, 35205, United States
Research Site
Huntington Park, California, 90255, United States
Research Site
Los Angeles, California, 90057, United States
Research Site
San Carlos, California, 94070, United States
Research Site
Hialeah, Florida, 33012, United States
Research Site
Miami Lakes, Florida, 33016, United States
Research Site
Orlando, Florida, 32806, United States
Research Site
West Palm Beach, Florida, 33401, United States
Research Site
Calabash, North Carolina, 28467, United States
Research Site
Morehead City, North Carolina, 28557, United States
Research Site
Magnolia, Texas, 77355, United States
Research Site
Aschaffenburg, 63739, Germany
Research Site
Essen, 45277, Germany
Research Site 2
Essen, 45355, Germany
Research Site 2
Hamburg, 21073, Germany
Research Site
Hamburg, 22607, Germany
Research Site
Heidelberg, 69115, Germany
Research Site
Magdeburg, 39120, Germany
Research Site
Wangen, 88239, Germany
Research Site
Bochnia, 32-700, Poland
Research Site
Bydgoszcz, 85-312, Poland
Research Site
Krakow, 30-015, Poland
Research Site 2
Krakow, 31-011, Poland
Research Site
Lodz, 90-242, Poland
Research Site 2
Lublin, 20-064, Poland
Research Site
Lublin, 20-362, Poland
Research Site
Olsztyn, 10-117, Poland
Research Site
Poznan, 61-655, Poland
Research Site
Puławy, 24-100, Poland
Research Site
Staszów, 28-200, Poland
Research Site
Swarzędz, 62-020, Poland
Research Site
Świdnik, 21-040, Poland
Research Site
Torun, 87-100, Poland
Research Site
Warsaw, 00-660, Poland
Research Site
Zamość, 22-400, Poland
Research Site
Alicante, Spain
Research Site 2
Barcelona, Spain
Research Site
Barcelona, Spain
Research Site 2
Madrid, Spain
Research Site 3
Madrid, Spain
Research Site
Madrid, Spain
Research Site 2
Málaga, Spain
Research Site
Málaga, Spain
Research Site 2
Oviedo, Spain
Research Site
Valencia, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Albert Collinson
- Organization
- Theracos Sub, LLC
Study Officials
- STUDY DIRECTOR
J. Paul Lock, MD
Theracos Sub, LLC
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
May 3, 2016
First Posted
May 11, 2016
Study Start
August 15, 2016
Primary Completion
June 14, 2019
Study Completion
June 14, 2019
Last Updated
May 27, 2021
Results First Posted
May 27, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share