Status:
COMPLETED
Comparison of NovoFine® Needles (4 mm vs. 6 mm)
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
6-75 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00343343
Start Date
June 1 2006
End Date
August 1 2006
Last Update
February 8 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Novo Nordisk Investigational Site
Aalborg, Denmark, 9100
2
Novo Nordisk Investigational Site
Århus C, Denmark, 8000