Substitution of First Phase Insulin Response in Patient With Type 2 Diabetes.
Primary Purpose
Type 2 Diabetes
Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Insulin Aspart
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabtes, Postprandial hyperglycemia, Insulin treatment
Eligibility 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 -
Sites / Locations
- Gentofte University HospitalRecruiting
Outcomes
Primary Outcome Measures
Blood glucose fluctuations
Secondary Outcome Measures
number of hypoglycemia
Full Information
NCT ID
NCT00254085
First Posted
November 14, 2005
Last Updated
November 14, 2005
Sponsor
University Hospital, Gentofte, Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT00254085
Brief Title
Substitution of First Phase Insulin Response in Patient With Type 2 Diabetes.
Official Title
Multiple Substitution of First Phase Insulin Response With a Rapid Action Insuli Analogue in Patient With Newly Diagnosed Type 2 Diabtes.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Gentofte, Copenhagen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabtes, Postprandial hyperglycemia, Insulin treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Insulin Aspart
Primary Outcome Measure Information:
Title
Blood glucose fluctuations
Secondary Outcome Measure Information:
Title
number of hypoglycemia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Gredal, MD
Phone
+45 39 77 79 76
Email
chgr@gentoftehosp.kbhamt.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte Gredal, MD
Organizational Affiliation
Gentofte University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gentofte University Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Gredal, MD
Phone
+45 39 77 79 76
Email
chgr@gentoftehosp.kbhamt.dk
First Name & Middle Initial & Last Name & Degree
Charlotte Gredal, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
19016075
Citation
Gredal C, Rosenfalck AM, Dejgaard A, Hilsted J. Targeting postprandial hyperglycaemia in patients with recently diagnosed type 2 diabetes with a fixed, weight-based dose of insulin Aspart. Scand J Clin Lab Invest. 2008;68(8):739-44. doi: 10.1080/00365510802207982.
Results Reference
derived
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Substitution of First Phase Insulin Response in Patient With Type 2 Diabetes.
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