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

Phase 4
Conditions
Type 2 Diabetes
Registration Number
NCT00254085
Lead Sponsor
University Hospital, Gentofte, Copenhagen
Brief 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.

Detailed 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 & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
20
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

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Blood glucose fluctuations
Secondary Outcome Measures
NameTimeMethod
number of hypoglycemia

Trial Locations

Locations (1)

Gentofte University Hospital

🇩🇰

Hellerup, Denmark

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