Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00497536
Status:
COMPLETED
Last Update Posted:
2009-02-05
First Post:
2007-07-04
Brief Title:
Pharmacokinetics of IAsp Following CSII in Patients With T1DM
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Pharmacokinetics of Insulin Aspart IAsp Following Continuous Subcutaneous Insulin Infusion CSII in Patients With Type 1 Diabetes Mellitus T1DM- Basal Rate Resolution
Status:
COMPLETED
Status Verified Date:
2009-02
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:
The primary objective of the study is to compare SSPIAsp during CSII giving one bolus per hour compared with multiple boluses per hour
The secondary objective is to compare SSPIAsp during continuous subcutaneous insulin infusion CSII versus continuous intravenous insulin infusion CIII
The secondary objective is to compare SSPIAsp during continuous subcutaneous insulin infusion CSII versus continuous intravenous insulin infusion CIII
Detailed Description:
Rapid acting insulin like insulin aspart can be administered as CSII The insulin can be administered as a basal rate with additional insulin administration from the pump related to mealtimes
Insulin is physiologically secreted in a pulsate manner from the pancreatic β-cells with a period of 5-10 minutes and this is responsible for plasma insulin oscillations with similar frequency The oscillatory pattern is believed to optimize control mechanisms of insulin to enhance its action on metabolism
Insulin is physiologically secreted in a pulsate manner from the pancreatic β-cells with a period of 5-10 minutes and this is responsible for plasma insulin oscillations with similar frequency The oscillatory pattern is believed to optimize control mechanisms of insulin to enhance its action on metabolism
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