Effect of Dapagliflozine on Systemic and Renal Endothelial Function

NCT02501616 | Unknown Phase 4

• 1 other identifier: BRMH 26-2014-148
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Function; Type 2 Diabetes

Keywords

SGLT2 inhibitor

Outcome Measures

Primary Outcomes (1)

• Reactive hyperemic index to measure endothelial function

  endothelial function

  8 weeks

Secondary Outcomes (3)

• N-acetyl-β-D-glucosaminidase as a measure of renal tubular injury

  8 week

• Urine albumin excretion ratio

  8 week

• Urine β2 microglobulin

  8 week

Study Arms (2)

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

Metformin DRUG

Dapagliflozin first; Metformin first

Dapagliflozin DRUG

Also known as: Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor

Dapagliflozin first; Metformin first

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Boramae medical center

Seoul, 156-707, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Min Kyong Moon, MD PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 12, 2015
• First Posted: July 17, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Last Updated: July 17, 2015

Record last verified: 2015-07

Locations

KR (1)