Comparison of NovoFine® Needles (4 mm vs. 6 mm)
A Comparative, Randomised Study With NovoFine® 4 mm Needle Versus NovoFine® 6 mm Needle in Regard to Anatomical Deposition of Sterile Air in Children and Thin Adults With Diabetes and Backflow of Test Medium (Only Adults) After Injection in Thigh and Abdomen
2 other identifiers
interventional
62
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 diabetes
Started Jun 2006
Shorter than P25 for phase_2 diabetes
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 19, 2006
CompletedFirst Posted
Study publicly available on registry
June 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedFebruary 8, 2017
February 1, 2017
2 months
June 19, 2006
February 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Deposition of sterile air depositions.
Secondary Outcomes (2)
Thickness of 1) dermis and 2) distance from skin surface to muscle fascia
Amount of backflow
Interventions
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (2)
Novo Nordisk Investigational Site
Aalborg, 9100, Denmark
Novo Nordisk Investigational Site
Århus C, 8000, Denmark
Related Publications (1)
Birkebaek NH, Solvig J, Hansen B, Jorgensen C, Smedegaard J, Christiansen JS. A 4-mm needle reduces the risk of intramuscular injections without increasing backflow to skin surface in lean diabetic children and adults. Diabetes Care. 2008 Sep;31(9):e65. doi: 10.2337/dc08-0977. No abstract available.
PMID: 18753661RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2006
First Posted
June 22, 2006
Study Start
June 1, 2006
Primary Completion
August 1, 2006
Study Completion
August 1, 2006
Last Updated
February 8, 2017
Record last verified: 2017-02