THR-1442-C-476

  • STATUS
    Recruiting
  • sponsor
    Theracos Sub, LLC
Updated on 25 March 2021

Summary

THR-1442-C-476

Description

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.

Details
Clinical Study IdentifierTX146014
SponsorTheracos Sub, LLC
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Inclusion Criteria
Male or female adult subjects with an age =40 years
Subjects with a diagnosis of T2DM
Subjects with HbA1c values of 7.5 – 11%, inclusive
Subjects who present with at least one of the following 3 histories
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 (Appendix 4) at the time of screening with a left ventricular ejection fraction (LVEF) = 40% and no subsequent LVEF > 40% documented within 6 months of screening. No more than 200 subjects with class II NYHA heart failure will be randomized in the study
Group 3: Age = 55 years with 2 or more of the following: a) diabetes duration of = 10 years, b) uncontrolled hypertension defined as SBP > 140 mmHg despite 3 or more anti-hypertensive medications c) current smoking, d) urine albumin:creatinine ratio (UACR) > 30 mg/g, e) eGFR of 45 to 60 mL/min/ 1.73 m2, or f) HDL < 1 mmol/L (38 mg/dL)
Female subjects of childbearing potential who are willing to use an adequate method of contraception and to not become pregnant for the duration of the study

Exclusion Criteria

Exclusion Criteria
Diagnosis of type 1 diabetes mellitus or maturity–onset/diabetes of the young (MODY)
Genitourinary tract infection within 6 weeks of screening or history of = 3 genitourinary infections requiring treatment within the last 6 months
Previous treatment with bexagliflozin or EGT0001474
Currently or within 3 months of taking any SGLT2 inhibitors
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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