drugset / Trial / NCT03376698
Dose-finding Study of Colchicine in Type 2 Diabetic Patients With Coronary Artery Disease
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Colchicine | Small molecule | 0.25 mg | Oral |
| Comparator | Colchicine | Small molecule | 0.5 mg | Oral |