type 2 diabetic patients with coronary artery disease
Conditions
Interventions
colchicine 0.5mg
colchicine 0.25mg
placebo
Sponsors
University of the Ryukyus Graduate School of Medicine Clinical Pharmacology and Therapeutics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with type 2 diabetes mellitus with coronary artery disease with increased inflammatory response. (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, patients with consent of performing optimal contraception from starting study drug to 90 days from final taking. (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
Exclusion criteria: (1)Patients with prior hypersensitivity to Colhicine. (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 a. Strong Inhibitor Atazanavir, Clarithromycin, Indinavir, Itraconazole, Nelfinavir, Ritonavir, Saquinavir, Darunavir, Telithromycin, Telaprevir, Preparation including Cobicistat b. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| High sensitive-CRP at 4 weeks | — |
Countries
Japan
Contacts
Public ContactYUMI IKEHARA
University of the Ryukyus Hospital Clinical Research and Quality Management Center
Outcome results
None listed