Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353990
Status:
COMPLETED
Last Update Posted:
2007-04-25
First Post:
2006-07-18
Brief Title:
Bioavailability of Insulin Administered in Duodenum
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Bioavailability Pharmacokinetics and Pharmacodynamics of Insulin Aspart Administered in the Duodenum in Healthy Volunteers - an Open Single Blinded and Uncontrolled Explorative Trial
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A study of the bioavailability of insulin after infusion in the duodenum in healthy volunteers
Detailed Description:
METHODOLOGY All subjects will be admitted fasting to the Clinical Trial Unit at Århus Community Hospital at 8 am A Gastrointestinal tube will be placed in Duodenum distal to papilla Vaterii with a pH of approximately 70 as measured by the pH meter distal in the tube An indwelling catheter for glucose infusion 20 in cases of hypoglycaemia will be placed in an antecubital vein In the contralateral anticubital vein a catheter will be placed for blood sampling All subjects will have 4 tests with duodenal infusion of the insulin Aspart solution The first 4 volunteers will receive 4 doses of insulin Aspart solution in 1 ml 150 300 600 and 1000 IU with 3-6 hours apart Blood sampling for Insulin Aspart total insulin and glucose Beckmann apparatus will be done every 10 minutes the first two hours and then every 20 minutes When final the subjects will receive a meal before leaving the hospital
Based on data from the pilot a dose will be determined for the remaining 8 subjects These will then based again on results from the pilot on two separate study days receive 4 infusions with 3-6 hours split Two infusions will be at pH 7 and two infusions will be more proximal at a pH of 55 two different insulin concentrations but the same dose given at the two places in Duodenum Frequency and interval of blood sampling in the second part will be determined by results from the pilot study For comparison with the clinical situation and estimation of bioavailability all subjects will receive a subcutaneous and an intravenous iv bolus injection of 6 IU of insulin Aspart The iv injection will be followed by blood sampling for three hours as above but every 5 minutes the first two hours and the sc injection will be followed by blood sampling for three hours as above but again with 10 minutes interval the first two hours
Based on data from the pilot a dose will be determined for the remaining 8 subjects These will then based again on results from the pilot on two separate study days receive 4 infusions with 3-6 hours split Two infusions will be at pH 7 and two infusions will be more proximal at a pH of 55 two different insulin concentrations but the same dose given at the two places in Duodenum Frequency and interval of blood sampling in the second part will be determined by results from the pilot study For comparison with the clinical situation and estimation of bioavailability all subjects will receive a subcutaneous and an intravenous iv bolus injection of 6 IU of insulin Aspart The iv injection will be followed by blood sampling for three hours as above but every 5 minutes the first two hours and the sc injection will be followed by blood sampling for three hours as above but again with 10 minutes interval the first two hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None