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

Type 2 Diabetes Clinical Trial

Official title: Multiple Substitution of First Phase Insulin Response With a Rapid Action Insuli Analogue in Patient With Newly Diagnosed Type 2 Diabtes.

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

• NCT number: NCT00254085
• Study type: Interventional
• Source: University Hospital, Gentofte, Copenhagen
• Contact: Charlotte Gredal, MD
• Phone: +45 39 77 79 76
• Email: chgr@gentoftehosp.kbhamt.dk
• Status: Recruiting
• Phase: Phase 4
• Start date: March 2005
• Completion date: March 2006