Comparison of 2 NovoFine® Needles on the Reflux of Insulin
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 1Delivery SystemsDiabetes
- Registration Number
- NCT00872560
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Weighing of reflux of insulin 6 seconds after injection
- Secondary Outcome Measures
Name Time Method Reactions at injection sites after 6 weeks of treatment Pain perception after 6 weeks of treatment Number and severity of bleedings after 6 weeks of treatment
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇮🇹Chieti, Italy