Comparison of 2 NovoFine® Needles on the Reflux of Insulin

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

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.

Inclusion Criteria:

• 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%

Exclusion Criteria:

• 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