EUCTR2018-003022-89-GR进行中（未招募）1 期
GUT-DERIVED INCRETIN HORMONES IN THE PATHOPHYSIOLOGY OF TYPE 1 DIABETES MELLITUS; EFFECT OF METFORMIN TREATMENT (THE INCREDIBLE-ME TRIAL) - INCREDIBLE ME
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Age = 18 years
- •T1DM (Diagnosis of diabetes before the age of 35 years and insulin use within 1 year from diagnosis)
- •Treatment with multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •Acute or within the last 3 months cardiovascular disease
- •NYHA stage 3 or 4 heart failure
- •Uncontrolled angina
- •Liver failure [AST>135 IU/L or ALT>129IU/L (3 x the upper normal limit)]
- •Kidney failure or GFR<60 ml/min/1.73m2
- •Gastrointestinal disease or gastroparesis
- •Prior diagnosis of cancer within 2 years
- •Other medication that affect glucose metabolism within the last 3 months (metformin, SGLT2, GLP-1 analogues, amylin analogues, systemic glucocorticoids)
- •Untreated or uncontrolled thyroid disease
- •Pregnancy or breastfeeding
- •Alcohol consumption > 2-drinks per day or other substance abuse.
研究者
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