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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Odense University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Insulin NovoRapid versus Actrapid Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Is Insulin NovoRapid Better Than Actrapid for Treating Type 1 Diabetic Patients When Simultaneously, Daily Adjusting the Insulin Dose?
Study Start Date : November 2004
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Meal-regulated insulin time two peaks after the two intervention periods


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145353


Locations
Denmark
Diabetes Research Center
Odense, Funen, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Iben B. Jacobsen, MD Odense University Hospital

ClinicalTrials.gov Identifier: NCT00145353     History of Changes
Other Study ID Numbers: 007
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: October 11, 2006
Last Verified: October 2006

Keywords provided by Odense University Hospital:
type 1 diabetes mellitus
hypoglycaemia
insulin profiles
growth hormone
cortisol
glucagon

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs