drugset / Trial / NCT03376698

Dose-finding Study of Colchicine in Type 2 Diabetic Patients With Coronary Artery Disease

NCT03376698

Phase 2 Completed 54 enrolled University of the Ryukyus
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is designed to investigate dose-dependent effects of low dose colchicine on inflammatory responses, endothelial function in type 2 diabetic patients with coronary artery disease and leukocyte activation. This study also tested the relationship between doses and safety issue such as incidence of diarrhea. Eligible patients will be randomly allocated to three treatment group: colchicine at 0.5mg per day, 0.25mg per day or placebo for 12 weeks in a double blind , parallel group design. High sensitive-CRP at 4 weeks as primary end point and flow mediated vasodilatation at 12 weeks as the secondary end point will be measured.

Timeline

Start
2017-06-15
Primary completion
2022-03-04
Completion
2022-04-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Colchicine Small molecule 0.25 mg Oral
Comparator Colchicine Small molecule 0.5 mg Oral