Impact of Dapagliflozin on DIAstolic Dysfunction in Type 2 Diabetic Patients

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02751398
• Other study ID #: 4-2015-1130
• Status: Completed
• Phase: Phase 4
• Start date: August 18, 2016
• Est. completion date: June 15, 2020

Study information

• Verified date: August 2020
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 15, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Dapagliflozin 10mg

• Placebo 10mg
Matching placebo for dapagliflozin 10 mg

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subclinical diastolic dysfunction assessed by supine bicycle diastolic stress echocardiography		24-week
Secondary	the impact of dapagliflozin on patients' functional capacity	functional capacity measured by maximum oxygen uptake (VO2max), Exercise time, Maximum exercise capacity (METs)	24-week
Secondary	the impact of dapagliflozin on resting diastolic function	Diastolic function measured by LV mass index, Grade of diastolic function, Ea velocity, Left atrial volume index	24-week