Bexagliflozin Efficacy and Safety Trial

• Status: Completed
• Trial end date: 2019-10-23
• Target enrollment: 0
• Participant gender: All

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) and increased risk of cardiovascular adverse events.

The data from this study will be combined with the data from other bexagliflozin studies in a meta-analysis of CV safety outcomes.

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

Details

• Lead Sponsor: Theracos
• Treatments: Bexagliflozin

Criteria

Inclusion Criteria:

• Subjects with a diagnosis of T2DM

• Subjects who have had a stable treatment regimen for T2DM for the past 3 months

• Subjects who present with at least one of the following 3 histories:

Group 1: A history of atherosclerotic vascular disease Group 2: A history of heart failure Group 3: Age ≥ 55 years with diabetes for ≥ 10 years, uncontrolled hypertension, currently smoking, reduced kidney function, or cholesterol problems

Exclusion Criteria:

• Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young

• History of genitourinary tract infections

• Evidence of abnormal liver function

• History of MI, stroke or hospitalization for heart failure in the past 3 months

• Prior kidney transplant or evidence of kidney problems

• Prior or planned pace maker implantation

• Pregnant or nursing