Comparison of 2 NovoFine® Needles on the Reflux of Insulin

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes; Delivery Systems

Treatments: Device: NovoFine® needle 6 mm; Device: NovoFine® needle 8 mm

Study type: Interventional

Funder types: Industry

Identifiers

NCT00872560

NEEDLEN/DCD/4/I

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)