Clinical Trial Details

Overview

Research Study Summary

A long-term 4+ year, double blind placebo controlled study to evaluate the effects of bexagliflozin on hemoglobin A1c in patients with type 2 diabetes and increased risk of cardiovascular adverse events

Purpose

Patients with type 2 diabetes have increased risk of developing cardiovascular complications. Improved control of hyperglycemia or blood pressure reduces the risk of diabetic complications Administration of bexagliflozin, a potent SGLT2 inhibitor, has been shown to be well tolerated and to decrease HbA1c in subjects with type 2 diabetes. Study THR-1442-C-476 is designed to demonstrate that bexagliflozin also improves glucose control in patients at higher risk of cardiovascular events. There may be additional benefits of bexagliflozin of weight loss and reduction of blood pressure.

To Learn more

CW ID: 218159
Date Last Changed: September 1, 2016

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
40 and up
Overall Status
Recruiting
Lead Sponsor
Theracos
Duration
4 Years
Facility Type
Out-Patient

Eligibility

Eligibility criteria:

  • Age ≥ 40 years old
  • Subjects with a diagnosis of diabetes, type 2 and HbA1c values of 7.5 – 11%
  • Stable diabetes treatment regimen for the past 3 months.
  • Subjects who present with at least one of the following cardiovascular histories:
    • Myocardial infarction (heart attack)
    • Stroke
    • Prior coronary artery bypass grafting or coronary stent
    • Congestive heart failure
    • Multiple cardiovascular risk factors including Age ≥ 55 years, diabetes duration of = 10 years, uncontrolled hypertension, current smoking, chronic kidney disease, or low HDL cholesterol

Contact

Jeffrey D. Wayne, MD, Principal Investigator
Clinical Trials Research
160 Gateway Drive, Suite 100
Lincoln, CA 95648
Phone: 916-434-8230
Fax: 916-434-8237

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Research Center Information:

Clinical Trials Research

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