MedTrace Logo

Effect of the Antidiabetic Drug Dapagliflozin on the Coronary Macrovascular and Microvascular Function in Type 2 Diabetic Patients

NCT05392959 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-04-26

No results posted yet for this study

Summary

Cardiovascular events remain a major driver of morbidity and mortality in patients with type 2 diabetes mellitus. Diffuse coronary atherosclerosis, combined with impairment of the microcirculation are frequent even in asymptomatic patients and can lead to unfavourable outcomes. In recent years, novel classes of antidiabetic drugs have been introduced, with salutary effects on cardiovascular outcomes of diabetic patients. The sodium-glucose linked transporter 2 (SGLT2) inhibitors - gliflozins - bind to the SGLT2 receptors of the proximal tubule of the nephron and cause glycosuria. They have been shown to have favourable cardiovascular effects by reducing deaths from cardiovascular causes in type 2 diabetic patients.

Moreover, dapagliflozin reduces hospitalisation for heart failure in type 2 diabetic heart failure patients with and without reduced ejection fraction and reduces cardiovascular death and all causes mortality in those with reduced ejection fraction.

It is currently unknown if this is mediated by improvement of coronary physiology both at the level of the epicardial coronary arteries as well as the coronary microcirculation.

The purpose of the study is to explore the impact of dapagliflozin on the coronary and microcirculatory function of type 2 diabetic patients.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Dapagliflozin 10 mg Tab

Dapagliflozin 10 mg per day

DRUG

Placebo

Placebo for dapagliflozin film-coated tablets 10 mg

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire Saint Pierre

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-06
Primary Completion
2023-07-17
Completion
2023-07-17

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT05392959 on ClinicalTrials.gov