Bioavailability, Pharmacokinetics and Pharmacodynamics of Insulin Aspart administered in the Duodenum in healthy volunteers – an open single blinded and uncontrolled exploratory trial
- Conditions
- MedDRA version: 9.0Level: PTClassification code 10012601Diabetes Mellitus
- Registration Number
- EUCTR2006-002803-15-DK
- Lead Sponsor
- Aarhus Sygehus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
•Healthy Volunteers
•Age >18 - < 50 years
•Female or male
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Any history of gastrointestinal or endocrine disorders (e.g. diabetes)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To define the bioavailability of insulin Aspart infused in the Duodenum<br>;Secondary Objective: •Evaluate pharmacokinetics of insulin following duodenal administration<br>•Evaluate intra- and intersubjects variation in pharmacokinetics<br>•Evaluate pharmacodynamics of insulin<br>•To assess any safety issues <br>•Explore any influence of pH / insulin concentration on PK /PD parameters<br>;Primary end point(s): •Pharmacokinetics assessed by insulin Aspart and total insulin measurements.<br>•Pharmacodynamics assessed by plasma glucose and further by need to change <br>glucose infusion<br>•Any adverse events<br>
- Secondary Outcome Measures
Name Time Method