NCT01449019已完成1 期
The Contribution of Glucagon-like Peptide 1 (GLP-1) to the Entero-insulinar Axis in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
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
- 24
- 试验地点
- 2
- 主要终点
- The incretin effect
研究概览
简要总结
The purpose of the study is to determine the contribution of endogenous Glucagon-like peptide 1 (GLP-1) to the postprandial secretion of insulin and glucagon and the incretin effect in healthy subjects and patients with type 2 diabetes mellitus (T2DM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female (postmenopausal, surgically sterile or using double-barrier method of contraception) healthy subjects and patients with type 2 diabetes mellitus (T2DM)
- •must be able to complete a 1 week wash-out of current anti-diabetic medications
- •Age 30-70 years
- •HbA1c (Hemoglobin A1c) ≤11% at screening
- •Body mass index (BMI) <40 kg/m2
- •Patients with type 2 diabetes mellitus (T2DM): Must have a fasting blood glucose of ≤12.2 mmol/L (240 mg/dL) at screening
- •Able to provide written informed consent prior to study participation
- •Able to communicate well with the investigator and comply with the requirements of the study
排除标准
- •Patients with type 1 diabetes mellitus (T1DM), diabetes as a result of pancreatic injury, or secondary forms of diabetes (eg Cushing, acromegaly)
- •Need for insulin within the previous 3 months
- •Use of Thiazolidinediones in the previous 4 weeks
- •Significant concomitant disease or complications of diabetes (i.e. nephropathy, autonomic dysfunction, orthostasis).
- •Treatment with systemic steroids and thyroid hormone (unstable dosage).
- •Patients with any history of gastrointestinal surgery, e.g. partial bowel resections, partial gastric resections, etc.
- •Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
- •Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
- •Significant illness within the two weeks prior to dosing.
- •Past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.
- •History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
- •history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
- •history or clinical evidence of pancreatic injury or pancreatitis;
- •history or presence of impaired renal function as indicated by abnormal creatinine or urea val-ues or abnormal urinary constituents (e.g., albuminuria);
- •evidence of urinary obstruction or difficulty in voiding at screening;
- •Polymorphonuclears <1500/µL at inclusion or platelet count < 100,000/μL at screening and baseline.
- •History of immunocompromise.
- •Evidence of liver disease as indicated by abnormal transaminases and alkaline phosphatase exceeding twice the upper limit of the normal range, and serum bilirubin should not exceed the value of 27 µmol/L (1.6 mg/dL).
研究组 & 干预措施
intravenous infusion
Active Comparator
干预措施: exendin(9-39)amide (Drug)
intravenous infusion
Active Comparator
干预措施: saline (Drug)
intraduodenal perfusion
Experimental
干预措施: duodenal meal (Other)
intraduodenal perfusion
Experimental
干预措施: duodenal saline (Other)
结局指标
主要结局
The incretin effect
时间窗: Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion
The incretin effect is the difference between postprandial plasma concentrations of insulin and C-peptide, respectively, and those during the isoglycemic fasting control experiment. The AUC is calculated after priming intravenous infusion (saline or exendin(9-39)) and under steady state duodenal meal perfusion.
次要结局
- Plasma concentrations of glucagon(Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion)
- Plasma concentrations of insulin(Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion)
- Plasma concentrations of Glucagon-like peptide-1(7-36) (GLP-1(7-36))(Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion)
- Plasma concentrations of C-peptide(Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion)
- Plasma concentrations of Glucose-dependent insulinotropic polpypeptide (GIP)(Area Under Curve (AUC) Time Frame: from 0 to 90 minutes under duodenal meal perfusion)
研究者
Joerg Schirra
Principal investigator, Clinical Professor
Ludwig-Maximilians - University of Munich
研究点 (2)
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