Skip to main content
OpenTrials
Completed

NCT Number: NCT02751398

Impact of Dapagliflozin on DIAstolic Dysfunction in Type 2 Diabetic Patients

This study aims to assess the impact of 24-week treatment of dapagliflozin in type 2 DM(diabetes mellitus) patients on diastolic dysfunction. Primary endpoint is assessing the impact of 24-week treatment of dapagliflozin in type 2 DM patients on subclinical diastolic dysfunction assessed by supine bicycle diastolic stress echocardiography. Secondary endpoint is assessing the impact of 24-week treatment of dapagliflozin in type 2 DM patients on functional capacity, he impact of 24-week treatment of dapagliflozin in type 2 DM patients at resting diastolic function. This is single-center, randomized, double-blind, placebo-controlled, parallel-arm intervention study.

This study is planned to evaluate the impact of dapagliflozin on diastolic dysfunction assessed. The dose of dapagliflozin will be 10 mg as approved.

For assessment of diastolic dysfunction, supine bicycle stress exercise echocardiography was performed, and changes in diastolic functional reserve, VO2max, exercise time, and maximal exercise capacity were assessed before and after treatment. This study will be randomized, double blind, placebo controlled, to minimize the risk of bias.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female and male aged 19~75 years
  • Type 2 DM and had not reached adequate glycemic control with a stable dose of metformin, sulfonylurea, or both drugs before screening
  • HbA1c 7.0% ~ 10% at screening (Patients who take metformin only: HbA1C 6.5-10%)
  • Patients with ≥ grade 1 diastolic function (relaxation abnormality) at resting echocardiography
  • Patients provided with the written, informed consent to participate in this study

Exclusion criteria

  • Type 1 DM (Fasting c-peptide ≤ 0.78ng/dL(or 0.26 nM/L)), secondary diabetes, gestational diabetes
  • History of diabetic ketoacidosis, hyperglycemic hyperosmolar status
  • Estimated glomerular filtration rate < 60 mL/min/1.73m2
  • History of chronic cystitis or recurrent urinary tract infection
  • Currently on loop diuretics
  • Currently on medication known to affect glucose metabolism (e.g. corticosteroids, immunosuppressants)
  • Abnormal liver function (AST/ALT > x3 upper normal limit)
  • On weight loss program or taking weight loss medication
  • LV ejection fraction < 50% at resting echocardiography
  • Uncontrolled hypertension (systolic blood pressure >200mmHg and/or diastolic blood pressure >110mmHg)
  • History of acute myocardial infarction, unstable angina, coronary artery bypass graft or stroke within 6 months
  • Inducible ECG abnormalities at exercise
  • Cardiomyopathy, significant valvular heart disease, or a significant arrhythmia
  • Patients who cannot perform supine bicycle stress echocardiography
  • Pregnant or lactating women
  • Subjects who the investigator deems inappropriate to participate in this study

Treatment and study plan

Dapagliflozin 10mg

Drug

Placebo 10mg

Drug

Matching placebo for dapagliflozin 10 mg

Primary outcomes

  1. subclinical diastolic dysfunction assessed by supine bicycle diastolic stress echocardiography

    Time frame: 24-week

Secondary outcomes

  1. the impact of dapagliflozin on patients' functional capacity

    Time frame: 24-week

    functional capacity measured by maximum oxygen uptake (VO2max), Exercise time, Maximum exercise capacity (METs)

  2. the impact of dapagliflozin on resting diastolic function

    Time frame: 24-week

    Diastolic function measured by LV mass index, Grade of diastolic function, Ea velocity, Left atrial volume index

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Impact of Dapagliflozin on DIAstolic Dysfunction in Type 2 Diabetic Patients: The IDDIA Study

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 26, 2016
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.