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

This study has been completed.

Sponsored by: Novo Nordisk
Information provided by: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00343343
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Device: NovoFine needle 6 mm
Device: NovoFine needle 4 mm
Phase II

MedlinePlus related topics:   Diabetes   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety Study
Official Title:   Comparison of NovoFine 4 mm Needle Versus NovoFine 6 mm Needle in Regard to Anatomical Deposition of Sterile Air and Backflow of Test Medium After Injection in Thigh and Abdomen in Subjects With Diabetes.

Further study details as provided by Novo Nordisk:

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

Estimated Enrollment:   63
Study Start Date:   June 2006

  Eligibility
Ages Eligible for Study:   6 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343343

Locations
Denmark
      Århus, Denmark

Sponsors and Collaborators
Novo Nordisk

Investigators
Study Director:     Christina Jørgensen, Msc. Pharm     Novo Nordisk A/S    
  More Information

Publications indexed to this study:

Study ID Numbers:   PDS322-1749
First Received:   June 19, 2006
Last Updated:   January 16, 2008
ClinicalTrials.gov Identifier:   NCT00343343
Health Authority:   Denmark: Danish Medicines Agency

Keywords provided by Novo Nordisk:
Needles  

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 05, 2008




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