EUCTR2016-001365-92-DK进行中（未招募）1 期
Meal-time Administration of exenatide for Glycaemic control in type 1 diabetic Cases: A randomised, placebo-controlled trial - MAG1C
Center for Diabetes Research, Gentofte Hospital0 个研究点目标入组 100 人开始时间: 2016年7月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •Inclusion criteria
- •T1D according to WHO criteria with duration of =1 year
- •Age =18 years
- •BMI >22.0 kg/m2
- •HbA1c >7.5% and <10.0% at visit 0 (screening)
- •Able to count carbohydrates
- •Able to understand the written patient information and to give informed consent
- •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
- •Exclusion criteria
- •Insulin pump treatment
- •Hypoglycaemia unawareness (inability to register low blood glucose)
- •Diabetic gastroparesis
- •Compromised kidney function (eGFR <60 ml/min/1.73m2, dialysis or kidney transplantation)
- •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)
- •History of acute and/or chronic pancreatitis
- •Subjects with personal or family history of medullary carcinoma or MEN syndrome
- •Inflammatory bowel disease
- •Cancer unless in complete remission for >5 years
- •Proliferative retinopathy
- •Other concomitant disease or treatment that according to the investigator's assessment makes the patient 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
- •Known or suspected hypersensitivity to trial product or related products
- •Receipt of an investigational drug within 30 days prior to visit 0
- •Simultaneous participation in any other clinical intervention trial
- •Withdrawal criteria
- •In case of pregnancy (or desire for pregnancy), female subjects are withdrawn
- •Lack of compliance to any of the important study procedures in the discretion of the investigator
- •Onset of any disorder considered to compromise the safety by participating in the study
- •Unacceptable adverse effects in the discretion of the investigator
- •Withdrawal on participants request will be accepted at any time without further justification
- •Withdrawn patients will not be replaced.
研究者
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