Insulin NovoRapid Versus Actrapid in Treatment of Type 1 Diabetic Patients During Daily Adjustment of Insulin Dose

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00145353
Recruitment Status : Unknown
Verified October 2006 by Odense University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 5, 2005
Last Update Posted : October 11, 2006
Information provided by:
Odense University Hospital

September 2, 2005
September 5, 2005
October 11, 2006
November 2004
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Meal-regulated insulin time two peaks after the two intervention periods
Same as current
Complete list of historical versions of study NCT00145353 on Archive Site
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Insulin NovoRapid Versus Actrapid in Treatment of Type 1 Diabetic Patients During Daily Adjustment of Insulin Dose
Is Insulin NovoRapid Better Than Actrapid for Treating Type 1 Diabetic Patients When Simultaneously, Daily Adjusting the Insulin Dose?
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.
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Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
Drug: Insulin NovoRapid versus Actrapid
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
June 2006
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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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Odense University Hospital
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Principal Investigator: Iben B. Jacobsen, MD Odense University Hospital
Odense University Hospital
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP