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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00343343
First received: June 19, 2006
Last updated: June 20, 2012
Last verified: June 2012
  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
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems
Device: NovoFine® needle 6 mm
Device: NovoFine® needle 4 mm
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Deposition of sterile air depositions. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 62
Study Start Date: June 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
Århus, Denmark
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Christina Jørgensen, Msc. Pharm Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00343343     History of Changes
Other Study ID Numbers: PDS322-1749, 2006-000174-78
Study First Received: June 19, 2006
Last Updated: June 20, 2012
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014