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

U

University Hospital, Gentofte, Copenhagen

Status and phase

Unknown
Phase 4

Conditions

Type 2 Diabetes

Treatments

Drug: Insulin Aspart

Study type

Interventional

Funder types

Other

Identifiers

NCT00254085
KA 03092s
2612-2368

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

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 -

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

Trial contacts and locations

1

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Central trial contact

Charlotte Gredal, MD

Data sourced from clinicaltrials.gov

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