Effect of Dapagliflozine on Systemic and Renal Endothelia... | NCT02501616

Studies
Effect of Dapagliflozine on Systemic and Renal Endothelial Function

NCT02501616

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Jul 17, 2015Estimated

Enrollment

22Estimated

Phase

Phase 4

Conditions

Endothelial Function
Type 2 Diabetes

Interventions

Metformin
Dapagliflozin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Not provided

First Submitted Date

Jul 12, 2015

First Submission Date that Met QC Criteria

Jul 15, 2015

First Posted Date

Jul 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2015

Last Update Posted Date

Jul 17, 2015Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metformin first	Active Comparator	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 Drug: Dapagliflozin
Dapagliflozin first	Active Comparator	Dapagliflozin first 8 wks --> Metformin 8wks. Dapagliflozin for initial 8 weeks. After 1 weeks of washout period, 8 weeks' metformin is followed.	Drug: Metformin Drug: Dapagliflozin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metformin	Drug		Dapagliflozin first Metformin first
Dapagliflozin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Min Kyong Moon, MD PhD	Contact	+82-2-870-2226		mkmoon@snu.ac.kr
Bo Kyung Koo, MD PhD	Contact	+82-2-870-2225		bokyungkoomd@gmail.com

Overall Officials

Name	Affiliation	Role
Min Kyong Moon, MD PhD	Boramae medical center, 20 Boramae-ro 5-gil,Dongjak-Gu,Seoul 156-707, Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boramae medical center	Recruiting	Seoul		156-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008687	Metformin
C529054	dapagliflozin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided