Effect of Dapagliflozine on Systemic and Renal Endothelial Function

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)

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02501616

Enrollment

Registered

2015-07-17

Start date

2014-12-31

Completion date

Unknown

Last updated

2015-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Function, Type 2 Diabetes

Keywords

SGLT2 inhibitor

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.

Interventions

DRUGMetformin

DRUGDapagliflozin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Reactive hyperemic index to measure endothelial function	8 weeks	endothelial function

Secondary

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

Countries

South Korea

Contacts

Primary ContactMin Kyong Moon, MD PhD

mkmoon@snu.ac.kr+82-2-870-2226

Backup ContactBo Kyung Koo, MD PhD

bokyungkoomd@gmail.com+82-2-870-2225

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026