Theracos Pharma Trial
Study Objective: A 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.
PI: Jay Shubrook
Study information Bexagliflozin is being developed by Theracos Sub, LLC (sponsor). It belongs to a class of drugs known as “SGLT2 inhibitors.” SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine..There are other SGLT2 inhibitors currently approved for the treatment of type 2 diabetes.
Purpose of the study The purpose of this study is to learn more about the safety of bexagliflozin in patients who have an increased risk of cardiovascular disease and the effect of bexagliflozin on HbA1c (hemoglobin A1c) level. HbA1c is a test that measures a person's average blood glucose (sugar) over the past 2 to 3 months. In diabetic patients, HbA1c becomes high when sugar levels in the blood are higher than normal.
Who can participate? The study population will consist of approximately 1650 subjects who have been diagnosed with sub-optimally controlled T2DM and who exhibit an elevated risk of cardiovascular events. The study population will comprise: Group 1: A history of atherosclerotic vascular disease as defined by one or more of the following: a) myocardial infarction (MI) or ischemic (non-hemorrhagic) stroke > 3 months but ≤ 5 years prior to screening or b) documented history of coronary, carotid, or peripheral arterial revascularization (coronary artery bypass grafting must have occurred ≥ 5 years prior to screening) Group 2: A history of NYHA class II or class III heart failure at the time of screening. No more than 200 subjects with class II NYHA heart failure will be randomized in the studyGroup 3: is now closed to enrollment.
What is required from me as a participant? The length of your participation is estimated to be 2 to 3 years, but it may vary. During the study you will visit the clinic about 8 times in the first year. There will also be a few visits conducted by phone. After week 48, clinic visits will be scheduled every 24 weeks and a phone interview will be conducted at 12 weeks after each clinic visit. During the treatment period you will take the study medication once a day by mouth and record your blood glucose in a diary.
What are the costs of taking part? There are no costs for you if you take part.
Payment for participation: You will be paid a small stipend at each visit for your inconvenience and refunded reasonable expenses including travel or parking that you incur because of this study.
For more information, please contact:
Lisa Johnson, RN, CCRP
Clinical Research Nurse
College of Osteopathic Medicine
Touro University California
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