Effect of Dapagliflozine on Systemic and Renal Endothelial Function

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Endothelial Function; Type 2 Diabetes

Treatments: Drug: Metformin; Drug: Dapagliflozin

Study type: Interventional

Funder types: Other

Identifiers

NCT02501616

BRMH 26-2014-148

Details and patient eligibility

About

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.

Enrollment: 22 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Metformin first

Active Comparator group

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.

Treatment:

Drug: Metformin

Drug: Dapagliflozin

Dapagliflozin first

Active Comparator group

Description:

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

Treatment:

Drug: Metformin

Drug: Dapagliflozin