Effect of Dapagliflozin on Vascular Functions in Patients With Type 2 Diabetes Compared to Gliclazide

NCT02610088 | Completed Phase 4 DMC

• 1 other identifier: B-1507/307-006
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators set up a clinical trial to compare effect of dapagliflozin, a sodium glucose co-transporter 2 inhibitor, with gliclazide on vascular function in patients with type 2 diabetes

Conditions

Diabetes

Keywords

Diabetes; Atherosclerosis; Cardiovascular disease; Endothelial dysfunction; Vascular function; Dapagliflozin; Gliclazide

Outcome Measures

Primary Outcomes (1)

• Vascular function assessed by Flow-mediated vasodilation (FMD)

  The diameter of the target artery is measured by high-resolution external vascular ultrasound in response to an increase in blood flow (causing shear-stress) during reactive hyperaemia (induced by cuff inflation and then deflation). This leads to endothelium-dependent dilatation; the response is contrasted with that to sublingual nitroglycerin, an endothelium-independent dilator. The artery is scanned and the diameter measured during three conditions; at baseline, during reactive hyperaemia (induced by inflation and then deflation of a sphygmomanometer cuff around the limb, distal to the scanned part of the artery) and finally after administration of sublingual nitroglycerin (which causes endothelium-independent smooth muscle mediated vasodilatation).

  24weeks

Secondary Outcomes (9)

• Change of blood pressure

  24weeks

• Lipid metabolism assessed by triglyceride, low density lipoprotein-cholesterol and high density lipoprotein-cholesterol

  24weeks

• Inflammatory markers assessed by hsCRP

  24weeks

• Change of body composition assessed by bioelectrical impedance analysis (BIA) methods

  24weeks

• Glucose metabolism assessed by glycated hemoglobin and fasting plasma glucose

  24weeks

Study Arms (2)

Dapagliflozin

ACTIVE COMPARATOR

Dapagliflozin will be started in patient with type 2 diabetes mellitus

Drug: Dapagliflozin

Gliclazide

ACTIVE COMPARATOR

Gliclazide will be started in patient with type 2 diabetes mellitus

Drug: Gliclazide

Interventions

Dapagliflozin DRUG

Dapagliflozin 10 mg, orally once daily at any time of day with or without food. If HbA1c does not decrease by \> 0.4% at 12 week, rescue therapy (sitagliptin 100 mg) can be added at investigator's discretion.

Also known as: Forxiga

Dapagliflozin

Gliclazide DRUG

Gliclazide MR 30 mg, orally once daily at any time of day with or without food. If HbA1c does not decrease by \> 0.4% at 12 week, rescue therapy (gliclazide MR 30 mg) can be added at investigator's discretion.

Also known as: Diamicron MR

Gliclazide

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes with HbA1c ≥ 7.5% at screening visit
• Male or female between 40 and 70 years of age
• Patients taking metformin (≥ 1000 mg or maximum tolerated dose) for more than 3 months
• BMI ≥23 kg/m²
• Estimated GFR ≥ 60 ml/min/1.73m²

You may not qualify if:

• Patients with acute coronary syndrome within 3 months prior to screening visit
• Pregnant or breast feeding women or reproductive-age women who refuse contraception
• Type 1 diabetes, gestational diabetes, or diabetes with secondary cause
• Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT \> 3-fold the upper limit of normal)
• Cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) except thyroid cancer or carcinoma in situ
• Other clinical trial within 30 days
• Alcohol abuse
• Contraindication to SGLT2 inhibitors or sulfonylurea

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus; Atherosclerosis; Cardiovascular Diseases

Interventions

dapagliflozin; Gliclazide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfonylurea Compounds; Urea; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2015
• First Posted: November 20, 2015
• Study Start: November 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 11, 2018

Record last verified: 2018-09

Locations

KR (1)