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

Tracking Information

First Received Date ^ICMJE

June 19, 2006

Last Updated Date

October 2, 2009

Start Date ^ICMJE

June 2006

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Deposition of sterile air depositions. [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Deposition of sterile air depositions.

Change History

Complete list of historical versions of study NCT00343343 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Thickness of 1) dermis and 2) distance from skin surface to muscle fascia
Amount of backflow

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety Study

Condition ^ICMJE

Diabetes Mellitus

Intervention ^ICMJE

Device: NovoFine® needle 6 mm
Device: NovoFine® needle 4 mm

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2006

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00343343

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study ID Numbers ^ICMJE

PDS322-1749

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Christina Jørgensen, Msc. Pharm

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

June 2009

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