EUCTR2012-001150-26-DK进行中（未招募）1 期
iraglutide in type 1 diabetes. A randomised, double-blind, placebo controlled study of the effect of liraglutide as an additional treatment to insulin on HbA1c, body weight and hypoglycaemia in poorly regulated type 1 diabetes patients. - Lira-1
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- 性别
- All
入选标准
- •Type 1 diabetes according to WHO criteria = 1 year
- •Age = 18 years
- •BMI > 25 kg/m2
- •HbA1c > 8.0 % at visit 0
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Insulin pump treatment
- •Hypoglycaemia unawareness (unability to register low blood glucose)
- •Diabetic gastroparesis
- •Compromised kidney function (eGFR < 60 ml/min/1,73m2), dialysis or kidney transplantation at visit 0
- •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 a week, and the last measured value as being conclusive)
- •Acute or chronic pancreatitis
- •Inflammatory bowel disease
- •Cancer unless in complete remission for > 5 years
- •History of thyroid adenoma or carcinoma
- •Alcohol/drug abuse
- •Fertile women not using contraceptives
- •Pregnant or nursing women
- •Simultaneous participation in any other clinical intervention trial
研究者
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