Reproducibility of insulin injected by needle-free jet-injection for glycaemic management in healthy volunteers
- Conditions
- Diabetes10018424
- Registration Number
- NL-OMON41800
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
• Age 18-50 years
• Body-Mass Index 18-32 kg/m2
• Blood pressure <160/90 mmHg
• 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)
• Treatment with systemic corticosteroids, immunosuppressive or cytostatic drugs
• Known allergy to aspart insulin
• 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
• Presence of any other medical condition that might interfere with the study protocol
• Pregnancy or the intention to become pregnant
• Anemia, defined as an Hb of <8.1 mmol/l for male subjects and <7.5 for female subjects
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary study in main study: the variability in glucose lowering effect as<br /><br>reflected by the exogenous glucose requirement over four hours.<br /><br>Primary study endpoint in sub-study: time to maximal glucose requirement.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study endpoints in main study include: variability of insulin<br /><br>absorption over four hours; times to peak insulin level and to maximal glucose<br /><br>requirement, safety and tolerability.<br /><br>Secondary endpoints in sub-study include: time to peak insulin level, peak<br /><br>insulin level, maximal glucose requirement, safety and tolerability.</p><br>