Effect of Dapagliflozine on Systemic and Renal Endothelial Function

Type 2 Diabetes Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02501616
• Other study ID #: BRMH 26-2014-148
• Status: Recruiting
• Phase: Phase 4
• First received: July 12, 2015
• Last updated: July 15, 2015
• Start date: December 2014

Study information

• Verified date: July 2015
• Source: Seoul National University Hospital
• Contact: Min Kyong Moon, MD PhD
• Phone: +82-2-870-2226
• Email: mkmoon[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Present with type 2 diabetes based on the disease diagnostic criteria as described by the World Health Organization (WHO)

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:

1. Previous history of IHD or brain infarct

2. Having typical anginal pain or atypical chest pain with dyspnea

3. Modification of Diet in Renal Disease (MDRD) estimated GFR=60 mL/min

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Endothelial Function
• Type 2 Diabetes

Intervention

Drug:
• Metformin

• Dapagliflozin

Locations

Country	Name	City	State
Korea, Republic of	Boramae medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reactive hyperemic index to measure endothelial function	endothelial function	8 weeks	No
Secondary	N-acetyl-ß-D-glucosaminidase as a measure of renal tubular injury	renal tubular injury	8 week	No
Secondary	Urine albumin excretion ratio	Urine albumin excretion	8 week	No
Secondary	Urine ß2 microglobulin		8 week	No