A Phase 4 interventional study of Dapagliflozin 10mg and Placebo 10mg in Type 2 Diabetes Mellitus, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-08-11.
Sponsored by Yonsei University · Phase 4, Interventional, and Treatment
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
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Exclusion Criteria:
Dapagliflozin 10mg/day
Drug: Dapagliflozin 10mg
Drug: Placebo 10mg
Matching placebo for dapagliflozin 10 mg
subclinical diastolic dysfunction assessed by supine bicycle diastolic stress echocardiography
Time frame: 24-week
the impact of dapagliflozin on patients' functional capacity
functional capacity measured by maximum oxygen uptake (VO2max), Exercise time, Maximum exercise capacity (METs)
Time frame: 24-week
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
Time frame: 24-week
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Yonsei University