Effect of Dapagliflozine on Systemic and Renal Endothelial Function

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Endothelial Function, Type 2 Diabetes

Intervention / Treatment
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* Drug: Metformin
* Drug: Dapagliflozin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin first<br>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. | Drug: Metformin<br> <br> Drug: Dapagliflozin<br> <br> * Other names: Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor;|
| Active Comparator: Dapagliflozin first<br>Dapagliflozin first 8 wks --> Metformin 8wks. Dapagliflozin for initial 8 weeks. After 1 weeks of washout period, 8 weeks' metformin is followed. | Drug: Metformin<br> <br> Drug: Dapagliflozin<br> <br> * Other names: Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reactive hyperemic index to measure endothelial function | endothelial function | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| N-acetyl-β-D-glucosaminidase as a measure of renal tubular injury | renal tubular injury | 8 week | 
| Urine albumin excretion ratio | Urine albumin excretion | 8 week | 
| Urine β2 microglobulin |  | 8 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SGLT2 inhibitor