Pharmacokinetic and Pharmacodynamic Profile of Rapid Acting Insulin Injected by Needle-free Jet-injection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- (time to) maximal glucose infusion rate
研究概览
简要总结
The purpose of this study is to compare the pharmacological profile of insulin administered with jet-injection with that of insulin injected with a conventional insulin pen.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-50 years
- •Body-mass index 18-28 kg/m2
- •Blood pressure <160/90 mmHg
- •Stable glycaemic control with HbA1c 6.5-9.0% (for patients with type 1 diabetes mellitus)
- •Duration of diabetes >1 year (for patients with type 1 diabetes mellitus)
排除标准
- •Inability to provide informed consent
- •Chronic use of medication other than oral contraceptives or thyroid hormone replacement therapy (with stable euthyroidism for at least 3 months)
- •Chronic use of medication other than insulin or low-dose angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) treatment (for patients with type 1 diabetes mellitus)
- •Type 2 diabetes in first-degree relatives (for healthy subjects)
- •History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty)
- •Pregnancy
- •Macroalbuminuria, i.e. urinary albumin excretion >200 microg/min in collected urine sample or urinary albumin-to-creatinine ratio >300 mg/g in spot urine sample (for patients with type 1 diabetes mellitus)
- •Symptomatic diabetic neuropathy (for patients with type 1 diabetes mellitus)
- •Proliferative diabetic retinopathy (a history of proliferative retinopathy that was successfully treated with laser coagulopathy is not an exclusion criterion) (for patients with type 1 diabetes mellitus)
研究组 & 干预措施
healthy low dose insulin
16 healthy non-diabetic volunteers. The type of insulin tested will be the rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.2 units per kg body weight.
干预措施: jet injector (SQ pen/Novopen III) (Device)
healthy high dose insulin
16 healthy non-diabetic volunteers. The type of insulin tested will be the rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.4 units per kg body weight.
干预措施: jet injector (SQ pen/Novopen III) (Device)
type 1 diabetes mellitus
16 people with type 1 diabetes mellitus. The type of insulin tested will be the rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.4 units per kg body weight.
干预措施: jet injector (SQ pen/Novopen III) (Device)
结局指标
主要结局
(time to) maximal glucose infusion rate
时间窗: 0-8 hours after insulin injection
次要结局
- (time to) maximal insulin concentration(0-8 hours after insulin injection)