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Substitution of First Phase Insulin Response in Patient With Type 2 Diabetes.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by University Hospital, Gentofte, Copenhagen.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00254085
First received: November 14, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

November 14, 2005
November 14, 2005
March 2005
Not Provided
Blood glucose fluctuations
Same as current
No Changes Posted
number of hypoglycemia
Same as current
Not Provided
Not Provided
 
Substitution of First Phase Insulin Response in Patient With Type 2 Diabetes.
Multiple Substitution of First Phase Insulin Response With a Rapid Action Insuli Analogue in Patient With Newly Diagnosed Type 2 Diabtes.
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Type 2 Diabetes
Drug: Insulin Aspart
Not Provided
Gredal C, Rosenfalck AM, Dejgaard A, Hilsted J. Targeting postprandial hyperglycaemia in patients with recently diagnosed type 2 diabetes with a fixed, weight-based dose of insulin Aspart. Scand J Clin Lab Invest. 2008;68(8):739-44. doi: 10.1080/00365510802207982.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
March 2006
Not Provided

Inclusion Criteria:

Type 2 diabtes according to the WHO criteria Fasting blood glucose >7 HbA1c between 6-9 Normal liver function Normal renal function

Exclusion Criteria:

Ongoing treatment with antidiabetic medicine Pregnancy and lactation -

Both
35 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00254085
2612-2368, KA 03092s
Not Provided
Not Provided
Not Provided
Not Provided
University Hospital, Gentofte, Copenhagen
Not Provided
Principal Investigator: Charlotte Gredal, MD Gentofte University Hospital
University Hospital, Gentofte, Copenhagen
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP