Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283218
Status:
COMPLETED
Last Update Posted:
2006-08-08
First Post:
2006-01-26
Brief Title:
A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart Biphasic Insulin Aspart 30 50 and 70
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
A Comparison of Pharmacodynamics and Pharmacokinetics of Insulin Aspart Biphasic Insulin Aspart 30 50 and 70 - A Randomised Quadruple Cross-Over Trial
Status:
COMPLETED
Status Verified Date:
2006-08
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 hypothesis is that an optimal formulation of fast acting and intermediary acting insulin analogues will improve post prandial glycaemic control in patients with type 1 diabetes
OBJECTIVE
The objective is to describe pharmacodynamic PD and pharmacokinetic PK profiles of Insulin Aspart IAsp Biphasic Insulin Aspart BIAsp 30 50 and 70 for a period of 12 hours following a standard test meal on four days respectively in subjects with type 1 diabetes
OBJECTIVE
The objective is to describe pharmacodynamic PD and pharmacokinetic PK profiles of Insulin Aspart IAsp Biphasic Insulin Aspart BIAsp 30 50 and 70 for a period of 12 hours following a standard test meal on four days respectively in subjects with type 1 diabetes
Detailed Description:
This trial is a single centre open-label randomised 4 period cross-over trial comparing the pk and pd profiles of IAsp BIAsp 30 BIAsp 50 and BIAsp 70 after a standard test meal in subjects with type 1 diabetes The profiles will be derived over a 12-hour period after subcutaneous injection in the abdominal region with a single dose of IAsp BIAsp 30 BIAsp 50 or BIAsp 70 at a test meal The trial consists of a screening period of 4-21 days and 4 treatment visits
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