Impact of Dapagliflozin on DIAstolic Dysfunction in Type 2 Diabetic Patients

NCT02751398 | Completed Phase 4

• 1 other identifier: 4-2015-1130
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• subclinical diastolic dysfunction assessed by supine bicycle diastolic stress echocardiography

  24-week

Secondary Outcomes (2)

• the impact of dapagliflozin on patients' functional capacity

  24-week

• the impact of dapagliflozin on resting diastolic function

  24-week

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Dapagliflozin 10mg/day

Drug: Dapagliflozin 10mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo 10mg

Interventions

Dapagliflozin 10mg DRUG

Dapagliflozin

Placebo 10mg DRUG

Matching placebo for dapagliflozin 10 mg

Placebo

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 26, 2016
• Study Start: August 18, 2016
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)