Effect of Dapagliflozine on Systemic and Renal Endothelial Function

Phase 4

• Conditions: Endothelial Function; Type 2 Diabetes
• Interventions: Drug: Metformin; Drug: Dapagliflozin

• Registration Number: NCT02501616
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Status Verified: 2015-07
• Study First Submitted: 2015-07-12
• Study First Submitted QC: 2015-07-15
• Last Update Submitted: 2015-07-15
• Study First Posted: 2015-07-17
• Last Update Posted: 2015-07-17
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dapagliflozin first	Metformin	Dapagliflozin first 8 wks --\> Metformin 8wks. Dapagliflozin for initial 8 weeks. After 1 weeks of washout period, 8 weeks' metformin is followed.
Metformin first	Metformin	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.
Metformin first	Dapagliflozin	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.
Dapagliflozin first	Dapagliflozin	Dapagliflozin first 8 wks --\> Metformin 8wks. Dapagliflozin for initial 8 weeks. After 1 weeks of washout period, 8 weeks' metformin is followed.

Primary Outcome Measures

Name	Time	Method
Reactive hyperemic index to measure endothelial function	8 weeks	endothelial function

Secondary Outcome Measures

Name	Time	Method
Urine β2 microglobulin	8 week
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

Trial Locations

Locations (1)

Boramae medical center; 🇰🇷 Seoul, Korea, Republic of