Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00254085
Status:
UNKNOWN
Last Update Posted:
2005-11-15
First Post:
2005-11-14
Brief Title:
Substitution of First Phase Insulin Response in Patient With Type 2 Diabetes
Sponsor:
University Hospital Gentofte Copenhagen
Organization:
University Hospital Gentofte Copenhagen
Study Overview
Official Title:
Multiple Substitution of First Phase Insulin Response With a Rapid Action Insuli Analogue in Patient With Newly Diagnosed Type 2 Diabtes
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
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 purpose of the project is to shown whether a little dose of a short acting insulin analogue given 3 time daily before the meals compared with placebo could normalise the increase in blood glucose after teh meals in diet treated Type 2 diabetic patients
Detailed Description:
Patients with Type 2 diabtes has a defect in the insulinsecretion combined with an increased insulin resistance At an intravenously glucosestimulation patients with Type 2 diabtes has a decresed first phase insulin response compared to healty peoples Because the hyperglycemia after meal observed i Type 2 diabetics patients is related to the defect in the first phase insulin response it is our hypothesis that substitution of the first phase insulin response with a little dose of insulin could normalise the blood glucose after the meal
20 patients with Type 2 diabetes will in a randomised placebocontrolled dobble-dummy study be included for three days treatment with Insulin aspart vs placebo Primary endpoint is bloodglucose fluctuations monitored by a continously glucose monitor
20 patients with Type 2 diabetes will in a randomised placebocontrolled dobble-dummy study be included for three days treatment with Insulin aspart vs placebo Primary endpoint is bloodglucose fluctuations monitored by a continously glucose monitor
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KA 03092s | None | None | None |