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

• Status: Completed
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Bundang Hospital
• Treatments: Dapagliflozin; Gliclazide

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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