The effect of rapid-acting insulin injected by needle-free jet-injection in the management of hyperglycemia in patients with diabetes - insulin by jet-injection for hyperglycemia in diabetes

niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•- Age 18-75 years
•- Body-Mass Index >=25 kg/m2 and <=40 kg/m2
•- Stable glycaemic control with HbA1c >=48 (6.5%) and <=86 mmol/mol (10%)
•- Insulin treatment according to basal-bolus regimen, i.e. by multiple daily injections at least four times daily, or by subcutaneous insulin pump, for at least 12 months, use of metformin allowed

•- Inability to provide informed consent
•- Insulin requirement of <34 or >200 units per day
•- Treatment with systemic corticosteroids, immunosuppressive or cytostatic drugs
•- Known allergy to aspart insulin
•- Use of oral antidiabetic drugs other than metformin
•- Symptomatic diabetic neuropathy
•- History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty) in the previous 6 months
•- Pregnancy or the intention to become pregnant
•- Renal disease (creatinine >150 µmol/l or MDRD-GFR <30 ml/min/1.73m2)
•- Liver disease (aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range)
•- Presence of any other medical condition that might interfere with the study protocol

发起方

niversitair Medisch Centrum Sint Radboud