NCT02919345

Assessment of Dapagliflozin Effect on Diabetic Endothelial Dysfunction of Brachial Artery

Comparative Study of Dapagliflozin Versus Glibenclamide Effect on Endothelial Function of Coronary Artery Disease Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: University of Campinas, Brazil · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Background Endothelial dysfunction is one of the early events in atherosclerotic plaque development. It is characterized by an increased ratio of substances with vasoconstrictive, pro-thrombotic, and proliferative properties over substances with vasolidatory, antithrombogenic and antimitogenic properties. Endothelial dysfunction is also associated with high-risk patients with coronary artery disease. Hyperglycemia, obesity, hypertension and fat mass also impair the endothelium by increasing the expression of cytokines, inflammatory markers and vascular markers. Hypothesis Administration of dapagliflozin in addition to metformin background with clinical or subclinical cardiovascular atherosclerotic disease improves endothelial function when compared to those using glibenclamide in addition to metformin. Objectives Evaluate the effect of dapagliflozin vs glibenclamide on a metformin background on endothelial function in patients with clinical or subclinical cardiovascular atherosclerotic disease and poorly controlled diabetes. Enpoints Prymary Change in flow mediated dilation (FMD) and its related endpoint (FMD post reperfusion lesion) between the randomization visit and over 12 weeks of treatment. Secondary Change in plasma nitric oxide, isoprostane, ICAM-1, VCAM-1, ET-1, leptin, adiponectin, C-reactive protein, TNF- α, interleukin-6, interleukin-2, weight and body composition (% of fat mass and % free fat mass) at the randomization visit and over 12 weeks of treatment. 3 Design Randomized, parallel-group, comparative, prospective clinical study. The study is divided in two phases: Run-in and Randomization. In the former phase, which must have the maximum period of 16 weeks, patients will visit the outpatient to adjust metformin and blood pressure medications. After run-in phase, patients that fulfill inclusion criteria will perform an ambulatory blood pressure monitoring (ABPM) in order to asses BP; body composition will be assessed by dual x-ray absorptiometry (DXA); endothelial function as assessed by flow mediated dilation and vascular cytokines. Patients will by randomized to dapagliflozin or glibenclamide on a metformin background. After 12 weeks, the ABPM, DXA and endothelial function will be assessed.

Conditions

• Diabetes Mellitus, Type 2
• Coronary Artery Disease
• Carotid Artery Diseases

Interventions

Type	Name	Description
DRUG	Dapagliflozin 10 mg	Dapagliflozin 10 mg in addition to Metformin 1500 mg/day
DRUG	Glibenclamide 5 mg	Glibenclamide 5 mg in addition to Metformin 1500 mg/day

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-12-01
• Completion: 2019-03-01
• First posted: 2016-09-29
• Last updated: 2023-03-10

Locations

1 site across 1 country: Brazil