Insulin NovoRapid Versus Actrapid in Treatment of Type 1 Diabetic Patients During Daily Adjustment of Insulin Dose
Information source: Odense University Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 1 Diabetes Mellitus
Intervention: Insulin NovoRapid versus Actrapid (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Odense University Hospital Official(s) and/or principal investigator(s):
Iben B. Jacobsen, MD, Principal Investigator, Affiliation: Odense University Hospital
Summary
The main purpose of the study is to investigate the reason for the reduced number of
hypoglycaemic attacks in type 1 diabetic patients when, for a period of time, using Insulin
Aspart at meals together with NPH insulin mornings and evenings, and when, in another period
of time, using human fast-working insulin at meals and NPH insulin mornings and evenings, and
when the patients in both periods simultaneously take extra insulin at meals if high blood
glucose values are found before meals.
Clinical Details
Official title: Is Insulin NovoRapid Better Than Actrapid for Treating Type 1 Diabetic Patients When Simultaneously, Daily Adjusting the Insulin Dose?
Study design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Meal-regulated insulin time two peaks after the two intervention periods
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Type 1 diabetes mellitus treated with insulin four times daily (basal bolus treatment)
at least three months before screening.
- AGe: 18-60 years
- BMI: 18-27. 5
- No nefro- or neuropathy; i. e. S-creatinin below 120 μmol/l and normal monofilament
examination
- Written informed consent
Exclusion Criteria:
- Pregnant women or patients planning to become pregnant during the investigation
period
- Reduced eyesight; i. e. visus > 0. 3 evaluated at the latest eye exam.
- Patient lacking the ability to sens insulin sensitivity
- Serious rival disease, i. e. heart disease, severe liver or lung impairment, severe
psychiatric disease.
- Suspicion of abuse or non-compliance
- Participation in another clinical trial
Locations and Contacts
Diabetes Research Center, Odense, Funen 5000, Denmark
Additional Information
Starting date: November 2004
Ending date: June 2006
Last updated: October 10, 2006
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