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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00254085

Enrollment

Registered

2005-11-15

Start date

2005-03-31

Completion date

2006-03-31

Last updated

2005-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Type 2 diabtes, Postprandial hyperglycemia, Insulin treatment

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.

Interventions

DRUGInsulin Aspart

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

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 -

Design outcomes

Primary

Measure	Time frame
Blood glucose fluctuations	—

Secondary

Measure	Time frame
number of hypoglycemia	—

Countries

Denmark

Contacts

Primary ContactCharlotte Gredal, MD

chgr@gentoftehosp.kbhamt.dk+45 39 77 79 76

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026