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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of the Ryukyus
• Treatments: Colchicine

Criteria

Inclusion Criteria:

• The subjects in this trial must have all of the following criteria.

1. Patients with type 2 diabetes mellitus with coronary artery disease(*1) with increased inflammatory response(*2).

• 1:"Type 2 diabetes" mellitus is diagnosed by criteria according to The Japan Diabetes Society. "Coronary artery disease" is defined as having equal to or greater than 75% stenosis in coronary angiography, history of acute coronary syndrome, and history of coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).

• 2:"Increased inflammatory response" is defined as follow; White blood cell levels at confirmation tests of eligibility is equal to or greater than 7500 /μL.

2. Patients aged 20 years and older

3. In female subjects who had possibility of pregnancy and male subjects who had female partner who had possibility of pregnancy and not undergone a contraceptive surgery(*3), patients with consent of performing optimal contraception from starting study drug to 90 days from final taking.

• 3: Male subjects who had undergone a contraceptive surgery are defined as elapsing for at least one year after vasectomy and having a certification of no sperm at ejaculation.

4. After receiving sufficient explanation for the participation of this study, patients who wrote document of informed consent by the patient's free will with sufficient understanding.

Exclusion Criteria:

• The subjects who conflict with at least one of the following criteria are exclude from this trial.

1. Patients with prior hypersensitivity to Colchicine.

2. Patients with taking Colhicine presently or to 30 days before confirmation tests of eligibility.

3. Patients with liver cirrhosis

4. Patients with clinical cholestasis.

5. Patients with decreasing renal function (eGFR < 30 mL/min/1.73m2) at confirmation tests of eligibility.

6. Patients with active malignancy.

7. Patients taking drugs that are indicated as "combined caution" in the package insert of Colchicine as a drug which may interact with Colchicine. 1. Drugs inhibiting cytochrome P450 drug-metabolizing enzyme

1. Strong Inhibitor Atazanavir, Clarithromycin, Indinavir, Itraconazole, Nelfinavir, Ritonavir, Saquinavir, Darunavir, Telithromycin, Telaprevir, Preparation including Cobicistat

2. Moderate Inhibitor Amprenavir, Aprepitant, Diltiazem, Erythromycin, Fluconazole, Fosamprenavir, Verapamil 2. P-glycoprotein inhibitor Ciclosporin

8. Patients taking Amiodarone or Quinidine.

9. Patients with infectious or inflammatory disease at confirmation tests of eligibility.

10. Current smoker

11. Patients with pregnancy, possible pregnancy, on breast-feeding or who wish to become pregnant during trial. (The female subjects who had possibility of pregnancy receive a pregnancy test.)

12. Patients registered in other clinical trials presently or within 30 days before acquisition consent of this trial.

13. Patients whom physician in charge considered inappropriate for the study.