Back to resultsComparison of NovoFine® Needles (4 mm vs. 6 mm)
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
NovoFine® needle 6 mm
NovoFine® needle 4 mm
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
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
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
Deposition of sterile air depositions.
Secondary Outcome Measures
Thickness of 1) dermis and 2) distance from skin surface to muscle fascia
Amount of backflow
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00343343
Brief Title
Comparison of NovoFine® Needles (4 mm vs. 6 mm)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Delivery Systems
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
NovoFine® needle 6 mm
Intervention Type
Device
Intervention Name(s)
NovoFine® needle 4 mm
Primary Outcome Measure Information:
Title
Deposition of sterile air depositions.
Secondary Outcome Measure Information:
Title
Thickness of 1) dermis and 2) distance from skin surface to muscle fascia
Title
Amount of backflow
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Ålborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Århus C
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
18753661
Citation
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Comparison of NovoFine® Needles (4 mm vs. 6 mm)
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