Comparison of 2 NovoFine® Needles on the Reflux of Insulin
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This trial is conducted in Europe. This trial aims to ensure that there is no substantial clinically relevant difference between the two Novo Nordisk needles NovoFine® 6 x 0.30 mm and NovoFine® 8 x 0.30 mm on reflux of insulin back to the surface of cutis.
Condition or disease
DiabetesDiabetes Mellitus, Type 1Delivery Systems
Device: NovoFine® needle 6 mmDevice: NovoFine® needle 8 mm
Insulin Leakage and Pain Perception in IDDM Children or Adolescents, Where the Injections Are Performed With NovoFine™ 6 x 0.30 mm Needles and NovoFine® 8 x 0.30 mm Needles: An Open, Randomized, Two-period Cross-over, Multi-centre, Phase IIIb Trial at 4 Centres
Actual Study Start Date :
January 20, 1998
Actual Primary Completion Date :
July 27, 1998
Actual Study Completion Date :
July 27, 1998
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Ages Eligible for Study:
10 Years to 17 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Children/adolescents with type 1 diabetes mellitus
Usage of NovoPen® 1.5 for at least 3 months
Duration of insulin treatment more than 1 year
Normal weight according to Tanner scales
The means of the last 2 HbA1c measurements taken within the last 6 months must be less than 10.5%
Pregnancy or desire to become pregnant
Clinical relevant peripheral neuropathy as judged by the investigators
Pronounced lipodystrophy in accordance with investigator's evaluation
Use of drugs that can influence the trial
Coagulation disorders (use of anti-coagulants)
Serious, chronic diseases, making it highly unlikely that the subject can complete the trial