Comparison of NovoFine® Needles (4 mm vs. 6 mm)
Phase 2
Completed
- Conditions
- Diabetes Mellitus, Type 1DiabetesDiabetes Mellitus, Type 2Delivery Systems
- Registration Number
- NCT00343343
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this investigation is to explore the safety of a 4 mm needle compared to a 6 mm needle when injected in children and lean adults with diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
Inclusion Criteria
- Children
- Type 1 diabetes
- Insulin treatment for more than ½ year
- BMI lesser than or equal to 19 kg/m2
- Last HbA1c taken within the last year lesser than 10.5%
- Girls: only prepubertal
- Boys: both pre pubertal and pubertal. Adults
- Type 1 and 2 diabetes
- Insulin treatment for more than ½ year
- BMI lesser than or equal to 23 kg/m2
- Last HbA1c taken within the last year lesser than 10.5%
Exclusion Criteria
- Known or suspected allergy to trial product(s) or related products.
- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (including country-specific adequate measures, if any).
- Skin disease at abdomen and/or thigh
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Deposition of sterile air depositions.
- Secondary Outcome Measures
Name Time Method Amount of backflow Thickness of 1) dermis and 2) distance from skin surface to muscle fascia
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇰Århus C, Denmark