Overview

Effect of Dapagliflozin on the Progression From Prediabetes to T2DM in Subjects With Myocardial Infarction

Status:
Unknown status
Trial end date:
2021-01-31
Target enrollment:
0
Participant gender:
All
Summary
It is hypothesize that, because dapagliflozin will reverse the metabolic defects responsible for the development of prediabetes (i.e. insulin resistance and beta cell dysfunction) and progression from prediabetes to T2DM (beta cell dysfunction) and will cause weight loss, it will markedly reduce the progression from prediabetes to T2DM and reverse glucose tolerance to NGT in patients with prediabetes experiencing acute myocardial infarction. Further, it is hypothesized that the hemodynamic actions of dapagliflzoin will exert cardiovascular benefit in subjects with prediabetes and acute MI by reducing cardiac remodeling, preserve LV function and decrease the risk of development of heart failure and hospitalization for heart failure. Hence, aim to examine the impact of SGLT2 inhibitor on T2DM and cardiovascular risk in patients with prediabetes and cardiovascular disease. The primary objective of the study is to examine the effect of dapagliflozin (10 mg) on the progression from prediabetes to T2DM in patients with prediabetes who experience acute myocardial infarction (MI). A secondary objective is to examine the effect of dapagliflozin on a composite of CV outcome including incidence and hospitalization for heart failure in patients with prediabetes with acute MI. Other secondary outcome is the change from baseline to end of study in LD systolic and diastolic function.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hamad Medical Corporation
Treatments:
Dapagliflozin
Criteria
Inclusion Criteria:

1. Acute MI according to AHA criteria 4 weeks prior to recruitment

2. eGFR >60 ml/min

3. stable body weight (+2 kg) in the preceding 3 months

4. diagnosis of prediabetes based upon the ADA criteria (FPG=100-125 mg/dl, and/or 2-hour
plasma glucose=140-199 mg/dl

Exclusion Criteria:

1. eGFR<60 ml/min

2. T2DM or T1DM according to the ADA criteria

3. Subjects receiving medications known to affect glucose tolerance

4. Pregnancy or lactation

5. Major organ disease like cancer, chronic pulmonary or liver disease