NL-OMON35858已完成不适用
Pharmacology of rapid-acting insulin injected by needle-free jet-injection in patients with diabetes - Insulin administration by jet injection
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age 18-70 years
- •Body-mass index 18-30 kg/m2
- •Stable glycaemic control with HbA1c 6.5-9.0%
- •Duration of diabetes >1 year
- •Insulin use at least once daily or with subcutaneous pump
- •Blood pressure <160/90 mmHg
排除标准
- •Inability to provide informed consent
- •Requirement of <8 units of rapid-acting insulin (analogue) before meals
- •Chronic use of anticoagulants
- •Chronic use of sulphonylurea derivatives, GLP-1 based treatments, acarbose or thiazolidinediones
- •Chronic use of three or more blood pressure lowering agents (except thiazide diuretics)
- •Treatment with prednisolone, non-steriodal anti-inflammatory drugs (NSAIDs), immunosuppressive agents, cytostatic drugs, hormone therapy except insulin, thyroid supplementation and oral anticonceptives
- •Known allergy to aspart insulin
- •Macroalbuminuria, i.e. urinary albumin excretion >200 *g/min in collected urine sample or urinary albumin-to-creatinine ratio >300 mg/g in spot urine sample
- •Symptomatic diabetic neuropathy
- •Proliferative diabetic retinopathy (a history of proliferative retinopathy that was successfully treated with laser coagulopathy is not an exclusion criterion)
- •History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty)
- •Pregnancy or the intention to become pregnant
研究者
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