Comparison of NovoFine® Needles (4 mm vs. 6 mm)

Novo Nordisk

Status and phase

Completed

Phase 2

Conditions

Diabetes Mellitus, Type 1

Diabetes

Diabetes Mellitus, Type 2

Delivery Systems

Treatments

Device: NovoFine® needle 6 mm

Device: NovoFine® needle 4 mm

Study type

Interventional

Funder types

Industry

Identifiers

NCT00343343

2006-000174-78 (EudraCT Number)

PDS322-1749

Details and patient eligibility

About

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.

Enrollment

62 patients

Sex

All

Ages

6 to 75 years old

Volunteers

No Healthy Volunteers

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