Impact of Dapagliflozin on DIAstolic Dysfunction in Type 2 Diabetic Patients

Yonsei University

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Placebo 10mg

Drug: Dapagliflozin 10mg

Study type

Interventional

Funder types

Other

Identifiers

NCT02751398

4-2015-1130

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

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