Effect of Dapagliflozine on Systemic and Renal Endothelial Function
NCT ID: NCT02501616
Last Updated: 2015-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
22 participants
INTERVENTIONAL
2014-12-31
Brief Summary
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Subjects are randomized to initial metformin or initial dapagliflozin group and maintained initial treatment for 8 weeks. During that period, dose of dapagliflozin is maintained 10mg/day and metformin can be titrated upto 2000 mg/day. After 1 weeks of washout period, 8 weeks' cross-over is followed.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Metformin first
Metformin first 8 wks --\> Dapagliflozin 8wks.
Metformin for initial 8 weeks. During that period, metformin can be titrated upto 2000 mg/day. After 1 weeks of washout period, 8 weeks' dapagliflozin is followed. During that period, dose of dapagliflozin is maintained 10mg/day.
Metformin
Dapagliflozin
Dapagliflozin first
Dapagliflozin first 8 wks --\> Metformin 8wks.
Dapagliflozin for initial 8 weeks. After 1 weeks of washout period, 8 weeks' metformin is followed.
Metformin
Dapagliflozin
Interventions
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Metformin
Dapagliflozin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Treated with diet and exercise alone for recent 3 months
3. Aged 20-80 years
4. HbA1c 7\~9%
5. This inclusion criterion applies to females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopause) only.
* Are not breastfeeding.
* Test negative for pregnancy at the time of screening based on a blood serum pregnancy test.
* Intend not to become pregnant during the study.
Exclusion Criteria
2. Having typical anginal pain or atypical chest pain with dyspnea
3. Modification of Diet in Renal Disease (MDRD) estimated GFR≥60 mL/min
20 Years
80 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Min Kyong Moon
Associate Professor
Principal Investigators
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Min Kyong Moon, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Boramae medical center, 20 Boramae-ro 5-gil,Dongjak-Gu,Seoul 156-707, Korea
Locations
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Boramae medical center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BRMH 26-2014-148
Identifier Type: -
Identifier Source: org_study_id
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