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Impact of Dapagliflozin on DIAstolic Dysfunction in Type 2 Diabetic Patients

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ClinicalTrials.gov Identifier: NCT02751398
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Dapagliflozin 10mg Drug: Placebo 10mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : May 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dapagliflozin
Dapagliflozin 10mg/day
Drug: Dapagliflozin 10mg
Placebo Comparator: Placebo Drug: Placebo 10mg
Matching placebo for dapagliflozin 10 mg




Primary Outcome Measures :
  1. subclinical diastolic dysfunction assessed by supine bicycle diastolic stress echocardiography [ Time Frame: 24-week ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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% ~ 10% at screening
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751398


Locations
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Korea, Republic of
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Geu-Ru Hong, MD, PhD    82-2-2228-8443    GRHONG@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02751398     History of Changes
Other Study ID Numbers: 4-2015-1130
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs