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

• Status: Completed
• Trial end date: 2019-06-14
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theracos
• Treatments: Bexagliflozin; Glimepiride; Metformin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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