drugset / Trial / NCT02501616

Effect of Dapagliflozine on Systemic and Renal Endothelial Function

NCT02501616

Phase 4 Unknown 22 enrolled Seoul National University Hospital
RandomizedCrossoverOpen-labelTreatment

Summary

This 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.

Timeline

Start
2014-12
Primary completion
2015-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dapagliflozin Small molecule 10 mg
Comparator Metformin Small molecule 2000 mg