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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Hospital, Gentofte, Copenhagen.
Recruitment status was  Recruiting
Information provided by:
University Hospital, Gentofte, Copenhagen Identifier:
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.

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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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 -

35 Years to 75 Years
Contact: Charlotte Gredal, MD +45 39 77 79 76
2612-2368, KA 03092s
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