EUCTR2020-002712-51-FI进行中（未招募）1 期
Semaglutide as an adjunct to dieting in the treatment of type 2 diabetes – effects on glucose metabolism, prevention of weight regain and peripheral tissue metabolic activation
Kirsi Pietiläinen0 个研究点目标入组 75 人开始时间: 2020年12月23日最近更新:
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
- 75
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
- •Inclusion criteria for the group of type 2 diabetes
- •- Age =18 years and <65 years
- •- BMI: =27 kg/m2
- •- T2DM (HbA1c = 6% if on anti-diabetic medication or HbA1c =6.5% if non-medicated)
- •- Participant is willing and able to give informed consent for participation in the study
- •Inclusion criteria for the control group
- •- Age =18 years and <65 years
- •- BMI <25 kg/m2
- •- participants willing and able to give informed consent for participation in the study
- •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 75
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria for the group of type 2 diabetes
- •-Contraindication to trial drugs
- •- Use of insulin or GLP-1RAs (during the past 3 months)
- •- Use of anti-obesity drugs (during the past 3 months)
- •- Weight change of >5% during the past 3 months
- •- Bariatric surgery or planned bariatric surgery during the trial
- •- History of pancreatitis
- •- Impaired renal function (GFR<30 ml/min/1.73m2)
- •- Impaired hepatic function (ALAT>2 x upper limit normal)
- •- Clinically significant active cardiovascular disease
- •- Clinically significant abnormality in the ECG
- •- Cancer (except basal or squamous cell skin cancers)
- •- Major psychiatric disease (such as severe depression, bipolar disorder, schizophrenia)
- •- Substance abuse
- •- Learning disability
- •- Females of childbearing potential not using adequate contraceptive methods
- •- Pregnancy
- •- Lactation
- •- Any other condition that in the opinion of the investigator could interfere with the conduction of the study or interpretation of the study results
- •Exclusion criteria for the control group
- •- All others as above for the main study
研究者
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