Effect of Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor on Systemic and Renal Endothelial Function in Patients With Type 2 Diabetes Mellitus Without History of Coronary Artery Disease (SOCCER Trial)
Sponsor study identifier
interventional
22
1 country
1
Study Start
December 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
Not reported
Date not reportedThis is a phase 4, single center, randomized, open-labeled, cross-over design study. The primary objective of the study is to compare effect of dapagliflozine and metformin on endothelial function. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2014
Date type not reportedThis date has not been verified as actual or estimated.
July 12, 2015
Actual (reported)July 17, 2015
Actual (reported)December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Reactive hyperemic index to measure endothelial function
endothelial function
8 weeks
N-acetyl-β-D-glucosaminidase as a measure of renal tubular injury
8 week
Urine albumin excretion ratio
8 week
Urine β2 microglobulin
8 week
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.
Dapagliflozin first 8 wks --\> Metformin 8wks. Dapagliflozin for initial 8 weeks. After 1 weeks of washout period, 8 weeks' metformin is followed.
Boramae medical center
Seoul, 156-707, South Korea
Min Kyong Moon, MD PhD
Boramae medical center, 20 Boramae-ro 5-gil,Dongjak-Gu,Seoul 156-707, Korea
First Submitted
July 12, 2015
First Posted
July 17, 2015
Study Start
December 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2015
Estimated (date passed)Effect of Dapagliflozin on Glycemic Variability
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 17, 2015
Record last verified: 2015-07
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Source: ClinicalTrials.gov.
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