This trial is active, not recruiting.

Condition type 1 diabetes mellitus
Treatment insulin novorapid versus actrapid
Phase phase 4
Sponsor Odense University Hospital
Start date November 2004
End date June 2006
Trial size 16 participants
Trial identifier NCT00145353, 007


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Meal-regulated insulin time two peaks after the two intervention periods
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Is Insulin NovoRapid Better Than Actrapid for Treating Type 1 Diabetic Patients When Simultaneously, Daily Adjusting the Insulin Dose?
Principal investigator Iben B. Jacobsen, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2006.
Information provided to ClinicalTrials.gov by Odense University Hospital.