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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00343343
First Posted: June 22, 2006
Last Update Posted: February 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
June 19, 2006
June 22, 2006
February 8, 2017
June 2006
August 2006   (Final data collection date for primary outcome measure)
Deposition of sterile air depositions.
Same as current
Complete list of historical versions of study NCT00343343 on ClinicalTrials.gov Archive Site
  • Thickness of 1) dermis and 2) distance from skin surface to muscle fascia
  • Amount of backflow
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Delivery Systems
  • Device: NovoFine® needle 6 mm
  • Device: NovoFine® needle 4 mm
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
August 2006
August 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Years to 75 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00343343
PDS322-1749
2006-000174-78 ( EudraCT Number )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP