Status:
COMPLETED
Effects of SGLT-2 Inhibition on Myocardial Fibrosis and Inflammation as Assessed by Cardiac MRI in Patients With DM2
Lead Sponsor:
University of Washington
Collaborating Sponsors:
AstraZeneca
Conditions:
Type 2 Diabetes Mellitus
Myocardial Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
There is an unmet need for Cardiovascular Disease (CVD) risk reduction in patients with Type 2 Diabetes. In recent trials there has been promising findings of more effective glucose management and red...
Detailed Description
Given the unmet needs for CVD risk reduction in patients with Type 2 Diabetes Mellitus (T2DM), the promising findings of more effective glucose management and reductions in overall CVD events and hosp...
Eligibility Criteria
Inclusion
- Men and women at least 18 years of age
- Subjects with type-2 diabetes history \>=5 years
- HbA1C 7-10% with glucose control medications including insulin, metformin or sulfonylurea
- Medically stable
- Willing to participate and sign informed consent.
Exclusion
- Contraindication to MRI
- Currently or within last three months treatment with a SGLT2 inhibitor
- Currently taking glucagon-like peptide (GLP)-1 receptor antagonist
- Glomerular filtration rate (GFR) \<60 mL/min/1.73 m2
- Unstable or rapidly progressive renal disease
- Hypotension with systolic blood pressure (SBP) \<100 mmHg
- Hypersensitivity to dapagliflozin or any excipients
- Patients with severe hepatic impairment (Child-Pugh class C)
- Patients with active hepatitis B or C infection
- Any of the following CV/Vascular Diseases within 3 months prior to signing the consent at enrollment, as assessed by the investigator:
- Myocardial infarction
- Cardiac surgery or revascularization (CABG/PTCA)
- Unstable angina
- Heart Failure - New York Heart Association (NYHA) Class IV
- Transient ischemic attack (TIA) or significant cerebrovascular disease
- Unstable or previously undiagnosed arrhythmia
- Established peripheral artery disease (PAD)
- (18) Active bladder cancer (19) Recent episode of Diabetic ketoacidosis (DKA), frequent episodes of DKA (20) High risk of fractures, amputations and fibrosis (21) Women of child-bearing potential (ie, those who are not chemically or surgically sterilized or who are not post-menopausal) who have a positive pregnancy test at enrollment or randomization, OR women who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator, from the time of signing the informed consent until two weeks after the last dose of study drug, OR women who are breast-feeding.
Key Trial Info
Start Date :
February 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2022
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03782259
Start Date
February 26 2019
End Date
November 16 2022
Last Update
December 29 2023
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98104