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Effect of Dapagliflozine on Systemic and Renal Endothelial Function

Primary Purpose

Endothelial Function, Type 2 Diabetes

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Metformin
Dapagliflozin
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endothelial Function focused on measuring SGLT2 inhibitor

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Boramae medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Metformin first

Dapagliflozin first

Arm Description

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

Outcomes

Primary Outcome Measures

Reactive hyperemic index to measure endothelial function
endothelial function

Secondary Outcome Measures

N-acetyl-β-D-glucosaminidase as a measure of renal tubular injury
renal tubular injury
Urine albumin excretion ratio
Urine albumin excretion
Urine β2 microglobulin

Full Information

First Posted
July 12, 2015
Last Updated
July 15, 2015
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02501616
Brief Title
Effect of Dapagliflozine on Systemic and Renal Endothelial Function
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Function, Type 2 Diabetes
Keywords
SGLT2 inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metformin first
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dapagliflozin first
Arm Type
Active Comparator
Arm Description
Dapagliflozin first 8 wks --> Metformin 8wks. Dapagliflozin for initial 8 weeks. After 1 weeks of washout period, 8 weeks' metformin is followed.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Other Intervention Name(s)
Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor
Primary Outcome Measure Information:
Title
Reactive hyperemic index to measure endothelial function
Description
endothelial function
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
N-acetyl-β-D-glucosaminidase as a measure of renal tubular injury
Description
renal tubular injury
Time Frame
8 week
Title
Urine albumin excretion ratio
Description
Urine albumin excretion
Time Frame
8 week
Title
Urine β2 microglobulin
Time Frame
8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Kyong Moon, MD PhD
Phone
+82-2-870-2226
Email
mkmoon@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Kyung Koo, MD PhD
Phone
+82-2-870-2225
Email
bokyungkoomd@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Kyong Moon, MD PhD
Organizational Affiliation
Boramae medical center, 20 Boramae-ro 5-gil,Dongjak-Gu,Seoul 156-707, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boramae medical center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bokyung Koo
Email
bokyungkoomd@gmail.com
First Name & Middle Initial & Last Name & Degree
Min Kyong Moon

12. IPD Sharing Statement

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Effect of Dapagliflozine on Systemic and Renal Endothelial Function

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