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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00254085
• Other study ID #: 2612-2368
• Secondary ID: KA 03092s
• Status: Recruiting
• Phase: Phase 4
• First received: November 14, 2005
• Last updated: November 14, 2005
• Start date: March 2005
• Est. completion date: March 2006

Study information

• Verified date: September 2005
• Source: University Hospital, Gentofte, Copenhagen
• Contact: Charlotte Gredal, MD
• Phone: +45 39 77 79 76
• Email: chgr[@]gentoftehosp.kbhamt.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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 -

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

Intervention

Drug:
• Insulin Aspart

Locations

Country	Name	City	State
Denmark	Gentofte University Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose fluctuations
Secondary	number of hypoglycemia