Effect of Dapagliflozine on Systemic and Renal Endothelial Function

NCT ID: NCT02501616

Last Updated: 2015-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Brief Summary

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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

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Conditions

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Endothelial Function Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin first

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.

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Dapagliflozin

Intervention Type DRUG

Dapagliflozin first

Dapagliflozin first 8 wks --\> Metformin 8wks.

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

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Dapagliflozin

Intervention Type DRUG

Interventions

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Metformin

Intervention Type DRUG

Dapagliflozin

Intervention Type DRUG

Other Intervention Names

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Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Min Kyong Moon

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Min Kyong Moon, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Boramae medical center, 20 Boramae-ro 5-gil,Dongjak-Gu,Seoul 156-707, Korea

Locations

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Boramae medical center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Min Kyong Moon, MD PhD

Role: CONTACT

+82-2-870-2226

Bo Kyung Koo, MD PhD

Role: CONTACT

+82-2-870-2225

Facility Contacts

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Bokyung Koo

Role: primary

Other Identifiers

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BRMH 26-2014-148

Identifier Type: -

Identifier Source: org_study_id

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