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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Hospital, Gentofte, Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00254085
First received: November 14, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: Insulin Aspart
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Multiple Substitution of First Phase Insulin Response With a Rapid Action Insuli Analogue in Patient With Newly Diagnosed Type 2 Diabtes.

Resource links provided by NLM:


Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Blood glucose fluctuations

Secondary Outcome Measures:
  • number of hypoglycemia

Estimated Enrollment: 20
Study Start Date: March 2005
Estimated Study Completion Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254085

Contacts
Contact: Charlotte Gredal, MD +45 39 77 79 76 chgr@gentoftehosp.kbhamt.dk

Locations
Denmark
Gentofte University Hospital Recruiting
Hellerup, Denmark, 2900
Contact: Charlotte Gredal, MD    +45 39 77 79 76    chgr@gentoftehosp.kbhamt.dk   
Principal Investigator: Charlotte Gredal, MD         
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
Principal Investigator: Charlotte Gredal, MD Gentofte University Hospital
  More Information

No publications provided by University Hospital, Gentofte, Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00254085     History of Changes
Other Study ID Numbers: 2612-2368, KA 03092s
Study First Received: November 14, 2005
Last Updated: November 14, 2005
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University Hospital, Gentofte, Copenhagen:
Type 2 diabtes
Postprandial hyperglycemia
Insulin treatment

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014