Delivery Systems, Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DEVICENovoFine® needle 6 mm
DEVICENovoFine® needle 4 mm
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Deposition of sterile air depositions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Thickness of 1) dermis and 2) distance from skin surface to muscle fascia | — |
| Amount of backflow | — |
Countries
Denmark
Outcome results
None listed