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)
Overview
- Phase
- Phase 4
- Intervention
- Metformin
- Conditions
- Endothelial Function
- Sponsor
- Seoul National University Hospital
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Reactive hyperemic index to measure endothelial function
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
Min Kyong Moon
Associate Professor
Seoul National University Hospital
Eligibility Criteria
Inclusion Criteria
- •Present with type 2 diabetes based on the disease diagnostic criteria as described by the World Health Organization (WHO)
- •Treated with diet and exercise alone for recent 3 months
- •Aged 20-80 years
- •HbA1c 7\~9%
- •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
- •Previous history of IHD or brain infarct
- •Having typical anginal pain or atypical chest pain with dyspnea
- •Modification of Diet in Renal Disease (MDRD) estimated GFR≥60 mL/min
Arms & Interventions
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.
Intervention: Metformin
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.
Intervention: 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.
Intervention: Metformin
Dapagliflozin first
Dapagliflozin first 8 wks --\> Metformin 8wks. Dapagliflozin for initial 8 weeks. After 1 weeks of washout period, 8 weeks' metformin is followed.
Intervention: Dapagliflozin
Outcomes
Primary Outcomes
Reactive hyperemic index to measure endothelial function
Time Frame: 8 weeks
endothelial function
Secondary Outcomes
- Urine β2 microglobulin(8 week)
- N-acetyl-β-D-glucosaminidase as a measure of renal tubular injury(8 week)
- Urine albumin excretion ratio(8 week)