Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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).

Key facts

Study ID

NCT02769481

Run by

Theracos

People needed

426

Starts

2016-08-15

Expected to finish

2019-06-14

Last updated by the study team

2021-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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