Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-26 @ 5:58 PM
Study NCT ID:
NCT00824668
Status:
COMPLETED
Last Update Posted:
2017-01-06
First Post:
2009-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30 and Insulin Glargine and Insulin Glulisine Therapy in Subjects With Type 2 Diabetes
Sponsor:
Novo Nordisk A/S
Organization:
Study Overview
Official Title:
A Randomised, Open-labelled, 2-period Crossover Trial Investigating Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30 Thrice Daily and Basal-bolus Therapy With Insulin Glargine & Insulin Glulisine in Subjects With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2017-01
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:
This trial is conducted in Europe. The aim of this clinical trial is to compare the 24-hour pharmacodynamics/ pharmacokinetics of biphasic insulin aspart 30 (BiAsp 30) thrice daily treatment with that of a basal-bolus treatment with insulin glargine and insulin glulisine in type 2 diabetic subjects.
Pharmacodynamics is the glucose-lowering effect of the study medication over the entire observation phase from the time of administration and the efficacy period while the pharmacokinetics is the amount of the study insulin that can be determined in the blood.
Pharmacodynamics is the glucose-lowering effect of the study medication over the entire observation phase from the time of administration and the efficacy period while the pharmacokinetics is the amount of the study insulin that can be determined in the blood.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2006-006578-92 | EUDRACT_NUMBER | None | View |