NCT02212067已完成1 期
A Single-centre, Randomised, Double-blind, Multiple-dose, Placebo-controlled, Parallel-group Trial Investigating the Effects of Semaglutide on ß-cell Function in Subjects With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Area under the serum insulin concentration time curve from 0 to 10 minutes after a 25 g glucose bolus i.v. infusion (IVGTT,intravenous glucose tolerance test) over 2 minutes
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the effects of semaglutide on ß-cell function in subjects with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-64 years (both inclusive) at the time of signing the informed consent
- •For subjects with type 2 diabetes:
- •Male and female subjects diagnosed with type 2 diabetes
- •Treated with diet and exercise and/or metformin monotherapy. Metformin dose should be unchanged in a period of 30 days prior to screening
- •Body Mass Index (BMI) between 20.0-35.0 kg/m^2 (both inclusive)
- •Glycosylated haemoglobin (HbA1c) between 6.5-9.0 % (both inclusive)
- •For healthy control group for graded glucose infusion:
- •Healthy male and female subjects
- •BMI between 24.0-32.0 kg/m^2 (both inclusive)
- •HbA1c less than 6.5 %
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child bearing potential and not using an adequate contraceptive method. Women of child bearing potential must use an effective method of birth control for the duration of the trial and for subjects with type 2 diabetes for 5 weeks following the last dose of semaglutide. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices), or sexual abstinence or vasectomised partner
- •Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic
- •Use of any prescription or non-prescription medication which could interfere with trial pharmacokinetic or pharmacodynamic results, as judged by the investigator or specifically: a) current treatment with systemic (oral or i.v.) corticosteroids, non-selective betablockers, b) thyroid hormones are not allowed unless the use of these have been stable during the past 2 month prior to screening
- •History of drug/chemical substance abuse within 1 year prior to screening, or a positive result in the urine drug test
- •History of alcohol abuse within 1 year prior to screening, or a positive result in the alcohol breath test
- •Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
- •Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
研究组 & 干预措施
Semaglutide
Experimental
Total of 12 visits
干预措施: semaglutide (Drug)
Placebo
Placebo Comparator
Total of 12 visits
干预措施: placebo (Drug)
结局指标
主要结局
Area under the serum insulin concentration time curve from 0 to 10 minutes after a 25 g glucose bolus i.v. infusion (IVGTT,intravenous glucose tolerance test) over 2 minutes
时间窗: Day -1, day 86
Area under the serum insulin concentration time curve from 10-120 minutes after a 25 g glucose bolus i.v. infusion (IVGTT).
时间窗: Day -1, day 86
次要结局
- Area under the insulin secretion rate (ISR)-time curve within 0 to 10 min after i.v. arginine application; ISR will be derived from the C-peptide concentration profile(Day -1, day 86)
- Slope of the ISR vs. glucose curve (dose-response relationship)(Day -1, day 87)
- Area under the insulin secretion rate (ISR)-time curve within 0 to 10 min after i.v. glucose challenge(Day -1, day 86)
- 24-hour plasma glucose, glucagon, serum insulin, and C-peptide measured as total AUC0-24h during a test day with 3 standardised meals(Day -1, day 85)
- Area under the ISR-time curve within 10 to 120 min after i.v. glucose challenge(Day -1, day 86)
- Area under the ISR curve over the 5-12 mmol/L (90-216 mg/dL) glucose interval; ISR will be derived from the C-peptide concentration profile(Day -1, day 87)
研究者
研究点 (1)
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