Comparison of NovoFine® Needles (4 mm vs. 6 mm) - Full Text View

Sponsor:	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, Type 1 Diabetes Mellitus, Type 2 Delivery Systems	Device: NovoFine® needle 6 mm Device: NovoFine® needle 4 mm	Phase II

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 1 Diabetes Type 2

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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

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

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. No abstract available.

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:	January 25, 2012
Health Authority:	Denmark: Danish Medicines Agency

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders

Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 12, 2012