Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513643
Status:
COMPLETED
Last Update Posted:
2007-08-09
First Post:
2007-08-08
Brief Title:
Metabolic Effect of Insulin Aspart and Human Insulin in Different Doses
Sponsor:
Profil Institut für Stoffwechselforschung GmbH
Organization:
Profil Institut für Stoffwechselforschung GmbH
Study Overview
Official Title:
Pharmacodynamic and Pharmacokinetic Properties of Insulin Aspart Dose - Ranging vs Human Soluble Insulin
Status:
COMPLETED
Status Verified Date:
2007-08
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 metabolic effect of three different doses of insulin aspart and human insulin are investigated with the euglycaemic glucose clamp technique
Detailed Description:
Double-blind randomized 6-period cross-over study in 16 healthy subjects Each patient participates in 6 euglycemic glucose clamp experiments each
The time interval between the study days is 2 to 28 days At the clamp visits subjects are connected to a Biostator MTB Medizintechnik Ulm Germany and receive an intravenous human insulin infusion rate of 015 mUkgmin over the duration of each experiment to prevent a rise in endogenous insulin secretion After a baseline period of 2 h the trial drug 6 12 or 24 U of either Insulin Aspart or regular human insulin in random order are administered sc with a syringe into the abdominal wall Glucose infusion rates GIR necessary to keep blood glucose concentrations close to the clamp level of 90 mgdl 5 mmoll are administered and recorded by the Biostator every minute for a period of 12 h post-dosing Blood samples are drawn at regular intervals for the analysis of C-peptide and depending on the trial drug administered serum insulin or serum Insulin Aspart concentrations measured with specific ELISAs
The time interval between the study days is 2 to 28 days At the clamp visits subjects are connected to a Biostator MTB Medizintechnik Ulm Germany and receive an intravenous human insulin infusion rate of 015 mUkgmin over the duration of each experiment to prevent a rise in endogenous insulin secretion After a baseline period of 2 h the trial drug 6 12 or 24 U of either Insulin Aspart or regular human insulin in random order are administered sc with a syringe into the abdominal wall Glucose infusion rates GIR necessary to keep blood glucose concentrations close to the clamp level of 90 mgdl 5 mmoll are administered and recorded by the Biostator every minute for a period of 12 h post-dosing Blood samples are drawn at regular intervals for the analysis of C-peptide and depending on the trial drug administered serum insulin or serum Insulin Aspart concentrations measured with specific ELISAs
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