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

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:

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.

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

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