Substitution of First Phase Insulin Response in Patient With Type 2 Diabetes.
Recruitment status was Recruiting
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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. |
- Blood glucose fluctuations
- number of hypoglycemia
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | March 2006 |
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 |
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| Contact: Charlotte Gredal, MD | +45 39 77 79 76 | chgr@gentoftehosp.kbhamt.dk |
| 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 | |
| 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 May 19, 2013