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

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ClinicalTrials.gov Identifier: NCT00254085
Recruitment Status : Unknown
Verified September 2005 by University Hospital, Gentofte, Copenhagen.
Recruitment status was:  Recruiting
First Posted : November 15, 2005
Last Update Posted : November 15, 2005
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Insulin Aspart Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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.
Study Start Date : March 2005
Estimated Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Blood glucose fluctuations

Secondary Outcome Measures :
  1. number of hypoglycemia


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: November 15, 2005
Last Verified: September 2005

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

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