EUCTR2014-002285-76-DK进行中（未招募）1 期
The Effects of Liraglutide in Patients With Insulin Pump Treated Type 1 Diabetes: A Randomized, Placebo-Controlled Trial. The Lira Pump Trial. - The Lira Pump Trial.
适应症
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
- 性别
- All
入选标准
- •-Age 18 – 70 years
- •-T1D = 1 years
- •-BMI > 25 kg/m2
- •-HbA1c = 58 mmol/mol (7.5%)
- •-CSII use = 1 year
- •-Use of carbohydrate counting and the insulin pump bolus calculator
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Gastroparesis
- •-Impaired renal function (eGFR < 60 ml/min/1.73m2)
- •-Liver disease with ALAT > 2.5 times the upper limit of the reference interval
- •-Acute or chronic pancreatitis or history of chronic pancreatitis or idiopathic acute pancreatitis
- •-Inflammatory bowel disease
- •-History of cancer (except basal cell skin cancer) which in the investigators opinion could interfere with the results of the trial, or cancer during the past 5 years
- •-Thyroid adenoma
- •-Subjects with personal or family history of MTC or MEN2
- •-Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
- •-Known or suspected alcohol or drug abuse
- •-Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
- •-Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
- •-Simultaneous participation in any other clinical intervention trial
- •-Known or suspected hypersensitivity to Liraglutide
- •-Inability to understand the patient information and to give informed consent
- •-Acute treatment required proliferative retinopathy or maculopathy (macular oedema)
- •-Any Cardiac disorder which in the investigators opinion could interfere with the safety and results of the trial.
研究者
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