| Trial ID: | L6816 |
| Source ID: | NCT02751398
|
| Associated Drug: |
Dapagliflozin 10mg
|
| Title: |
Impact of Dapagliflozin on DIAstolic Dysfunction in Type 2 Diabetic Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Dapagliflozin 10mg|DRUG: Placebo 10mg
|
| Outcome Measures: |
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|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
|
| Sponsor/Collaborators: |
Sponsor: Yonsei University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-08-18
|
| Completion Date: |
2020-06-15
|
| Results First Posted: |
|
| Last Update Posted: |
2020-08-11
|
| Locations: |
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, 120-752, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT02751398
|