Substitution of First Phase Insulin Response in Patient With Type 2 Diabetes.
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Multiple Substitution of First Phase Insulin Response With a Rapid Action Insuli Analogue in Patient With Newly Diagnosed Type 2 Diabtes.|
- Blood glucose fluctuations
- number of hypoglycemia
|Study Start Date:||March 2005|
|Estimated Study Completion Date:||March 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254085
|Contact: Charlotte Gredal, MD||+45 39 77 79 firstname.lastname@example.org|
|Gentofte University Hospital||Recruiting|
|Hellerup, Denmark, 2900|
|Contact: Charlotte Gredal, MD +45 39 77 79 76 email@example.com|
|Principal Investigator: Charlotte Gredal, MD|
|Principal Investigator:||Charlotte Gredal, MD||Gentofte University Hospital|