Pharmacology of rapid-acting insulin injected by needle-free jet-injection in patients with diabetes
- Conditions
- Diabetes10018424
- Registration Number
- NL-OMON35858
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
•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
•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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Area under the baseline-subtracted plasma glucose concentration time-curve from<br /><br>time 0 to 2 h after insulin injection and meal ingestion (BG-AUC0-2h)</p><br>
- Secondary Outcome Measures
Name Time Method
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