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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Globin Zinc
Insulin
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014