Interactions Between Exogenous Insulin Aspart, Endogenous Insulin and Plasma Glucose in Type 2 Diabetes Mellitus Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pharmacokinetic profiles of endogenous insulin and Insulin Aspart
研究概览
简要总结
This is an exploratory trial with two cross-over arms investigating pharmacokinetic profiles of endogenous and exogenous insulin in type 2 diabetes mellitus patients treated with continuous subcutaneous Insulin Aspart infusion and combined with or without intravenous glucose infusion. The order of treatment session will be randomised.
Hypotheses:
- Secretion of endogenous insulin depends on exogenous insulin supply
- Secretion of endogenous insulin is depends on plasma glucose levels
详细描述
There are a screening visit and two treatment sessions:
Session A: Treatment with Insulin Aspart 1.5 IE/time overnight without intravenous glucose infusion Session B: Treatment with Insulin Aspart 1.5 IE/time overnight with intravenous glucose infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with type 2 diabetes mellitus
- •Insulin-naive patients
- •HbA1C < 9%
- •Women and men >= 35 and <= 75 years old
- •BMI 25-42 kg/m2, both values are included
排除标准
- •Suspected or known allergy to the trial drug or similar medications
- •Treatment with hte drugs that after Investigator judgment could potentially interfere with plasma glucose levels
- •Heart: Unstable angina pectoris, acute myocardial infarction within the last 12 months
- •Severe uncontrolled hypertension with blood pressure in lying position > 180/110 mmHg
- •Impaired liver function with liver parameters more than 2 times above the upper normal limit according to the local laboratory
- •Impaired kidney function with eGFR < 50 ml/min according to the local laboratory
- •Pregnancy, lactation or desire for pregnancy in the study period and for women in childbearing age without adequate contraception-adequate contraception is: sterilisation, hysterectomy or current use of contraceptive pills, coil, gestagen depot injection, subdermal implantation, hormonal vaginal ring and transdermal depot patch.
研究组 & 干预措施
Insulin Aspart without glucose supply
Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight without intravenous glucose supply
干预措施: Insulin Aspart 100 IE/ml (Drug)
Insulin Aspart with glucose supply
Treatment with continuous subcutaneous Insulin Aspart 0.5-1.5 IE/time infusion overnight combined with intravenous glucose supply
干预措施: Insulin Aspart 100 IE/ml (Drug)
结局指标
主要结局
Pharmacokinetic profiles of endogenous insulin and Insulin Aspart
时间窗: 10 hours
Pharmacokinetic profiles of endogenous insulin and Insulin Aspart in type 2 diabetes melitus patients treated with continuous subcutaneous Insulin Aspart infusion by insulin pump and combined with or without intravenous supply of glucose
次要结局
- Pharmacodynamic glucose profiles(10 hours)
研究者
Jurgita Janukonyte
Medical doctor
Aarhus University Hospital