2022-502038-23-00招募中2 期
Repurposing colchicine for reduction of residual inflammatory risk in type 1 diabetes (REC1TE): a randomized, double-blind, placebo-controlled, investigator-initiated trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Estimated treatment difference in high-sensitivity C-reactive protein (mg/l) for colchicine as compared with placebo after 26 weeks of treatment
研究概览
简要总结
The primary aim is to determine the effect of colchicine on levels of high-sensitivity C-reactive protein (mg/l) as compared with placebo following 26 weeks of treatment
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes for more than five years according to World Health Organization criteria
- •Age 18–80 years
- •HbA1c < 80 mmol/mol
- •Stable insulin therapy (defined as no change in insulin brand and not newly initiated continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI) therapy) and, if applicable, stable usage of glucose monitoring technology (e.g., continuous glucose monitoring CGM or intermittently scanned CGM) ≥ 3 months with either MDI or CSII
- •C-reactive protein ≥ 2 mg/l (measured by high-sensitivity assay)
- •Estimated glomerular filtration rate > 50 ml/min/l/1.73 m^2
- •Either stable atherosclerotic cardiovascular (CV) disease (as defined by ischaemic heart disease including previous acute myocardial infarction, acute coronary syndrome and coronary revascularization; other arterial revascularization procedures; stroke and transient ischaemic attack; aortic aneurysm; peripheral arterial disease, including carotid atherosclerosis) or high risk thereof ((i.e., high or very high CV risk) as defined by the European Society of Cardiology (Eur Heart J 2020; 41: 255–323) or 10-year CV risk ≥ 20 % (i.e., high CV risk) as according to ‘Steno Type 1 Diabetes Risk Engine’ (https://steno.shinyapps.io/T1RiskEngine/)
排除标准
- •Hypoglycemia unawareness (inability to register low blood glucose) am modum Pedersen-Bjergaard, unless usage of CGM with alarm function
- •On permanent treatment with colchicine that is not discontinued within 30 days of visit 0
- •Known or suspected hypersensitivity to colchicine
- •Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within seven days , and the last measured value as being conclusive)
- •Receipt of any investigational drug within 30 days prior to visit 0
- •Simultaneous participation in any other clinical intervention trial
- •History of cirrhosis, chronic active hepatitis or severe hepatic disease
- •Inflammatory bowel disease or chronic diarrhea
- •Pre-existing progressive neuromuscular disease or persons with creatinine kinase levels > three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
- •Cancer or lymphoproliferative disease unless in complete remission for > 5 years
- •Immunosuppressive therapy or state of chronic immunodeficiency, including infection with human immunodeficiency virus (HIV)
- •Thrombocyte count < 110 X 10^9/L
- •Blood dyscrasias (e.g., myelodysplastic syndromes or related hematological disorders)
- •Leukocyte cell count < 3.0 X 10^9/L
- •Intake of grape fruit juice during trial participation
- •Systemic (oral or intravenous), long-term steroid therapy (topical or inhaled steroids are allowed)
- •Hemodialysis or peritoneal dialysis therapy (since colchicine cannot be removed by dialysis or exchange transfusion)
- •Renal or hepatic impairment treated with a P-gp inhibitor or a strong CYP3A4 inhibitor
- •Other concomitant disease or treatment that according to the investigator's assessment makes the person unsuitable for study participation
- •Alcohol/drug abuse
- •Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
- •Pregnant or nursing women
结局指标
主要结局
Estimated treatment difference in high-sensitivity C-reactive protein (mg/l) for colchicine as compared with placebo after 26 weeks of treatment
Estimated treatment difference in high-sensitivity C-reactive protein (mg/l) for colchicine as compared with placebo after 26 weeks of treatment
次要结局
- High-sensitivity C-reactive protein (mg/l) (measured at week 30)
- Glycated haemoglobin (mmol/mol; %-point)
- Time spent in target glycemia (3.9–10 mmol/l) (% of 24 hours) as assessed by continuous glucose monitoring
- Time spent in hyperglycaemia level 1 (10–13.9 mmol/l) (% of 24 hours) as assessed by continuous glucose monitoring
- Time spent in hyperglycaemia level 2 (> 13.9 mmol/l) (% of 24 hours) as assessed by continuous glucose monitoring
- Time spent in hypoglycaemia level 1 (3.0–3.8 mmol/l) (% of 24 hours) as assessed by continuous glucose monitoring
- Time spent in hypoglycaemia level 2 (< 3.0 mmol/l) (% of 24 hours) as assessed by continuous glucose monitoring
- Insulin dosage, long-acting (units/day)
- Insulin dosage, short-acting (units/day)
- Body weight (kg)
- Waist:hip ratio
- Low-density lipoprotein cholesterol (mmol/l)
- Interleukin-6 (pg/ml)
- Tumour necrosis factor alpha (pg/ml)
- Serious adverse events (SAE)
- Events of severe hypoglycemia
- Events of diabetic ketoacidosis
研究者
Center for Clinical Metabolic Research
Scientific
Gentofte Hospital
研究点 (3)
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