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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00343343
First received: June 19, 2006
Last updated: May 13, 2016
Last verified: May 2016

June 19, 2006
May 13, 2016
June 2006
August 2006   (final data collection date for primary outcome measure)
Deposition of sterile air depositions. [ Designated as safety issue: No ]
Deposition of sterile air depositions.
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 [ Designated as safety issue: No ]
  • Amount of backflow [ Designated as safety issue: No ]
  • Thickness of 1) dermis and 2) distance from skin surface to muscle fascia
  • Amount of backflow
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
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: 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
Both
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
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
May 2016

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