MedTrace Logo

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

NCT03658031 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 576

Last updated 2019-01-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dapagliflozin 10mg

Dapagliflozin 10 mg administered each morning before breakfast

Sponsors & Collaborators

  • Hamad Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Jassim Al-Suwaidi, MD · Heart Hospital, HMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2020-12-31
Completion
2021-01-31

Countries

  • Qatar

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03658031 on ClinicalTrials.gov