Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects
NCT ID: NCT02769481
Last Updated: 2021-05-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
426 participants
INTERVENTIONAL
2016-08-15
2019-06-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Bexagliflozin
Subjects 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.
Bexagliflozin
20 mg, tablet
Placebo for Glimepiride
inactive capsules to match active comparator glimepiride
Glimepiride
Subjects 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.
Placebo for Bexagliflozin
inactive tablet to match active comparator bexagliflozin
Glimepiride
2, 4 or 6 mg, capsule
Interventions
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Bexagliflozin
20 mg, tablet
Placebo for Bexagliflozin
inactive tablet to match active comparator bexagliflozin
Glimepiride
2, 4 or 6 mg, capsule
Placebo for Glimepiride
inactive capsules to match active comparator glimepiride
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Theracos
INDUSTRY
Responsible Party
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Principal Investigators
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J. Paul Lock, MD
Role: STUDY_DIRECTOR
Theracos Sub, LLC
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Huntington Park, California, United States
Research Site
Los Angeles, California, United States
Research Site
San Carlos, California, United States
Research Site
Hialeah, Florida, United States
Research Site
Miami Lakes, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
West Palm Beach, Florida, United States
Research Site
Calabash, North Carolina, United States
Research Site
Morehead City, North Carolina, United States
Research Site
Magnolia, Texas, United States
Research Site
Aschaffenburg, , Germany
Research Site
Essen, , Germany
Research Site 2
Essen, , Germany
Research Site 2
Hamburg, , Germany
Research Site
Hamburg, , Germany
Research Site
Heidelberg, , Germany
Research Site
Magdeburg, , Germany
Research Site
Wangen, , Germany
Research Site
Bochnia, , Poland
Research Site
Bydgoszcz, , Poland
Research Site
Krakow, , Poland
Research Site 2
Krakow, , Poland
Research Site
Lodz, , Poland
Research Site 2
Lublin, , Poland
Research Site
Lublin, , Poland
Research Site
Olsztyn, , Poland
Research Site
Poznan, , Poland
Research Site
Puławy, , Poland
Research Site
Staszów, , Poland
Research Site
Swarzędz, , Poland
Research Site
Świdnik, , Poland
Research Site
Torun, , Poland
Research Site
Warsaw, , Poland
Research Site
Zamość, , 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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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THR-1442-C-480
Identifier Type: -
Identifier Source: org_study_id
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