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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343343
• Other study ID #: PDS322-1749
• Secondary ID: 2006-000174-78
• Status: Completed
• Phase: Phase 2
• First received: June 19, 2006
• Last updated: February 6, 2017
• Start date: June 2006
• Est. completion date: August 2006

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Delivery Systems
• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

Device:
• NovoFine® needle 6 mm

• NovoFine® needle 4 mm

Locations

Country	Name	City	State
Denmark	Novo Nordisk Investigational Site	Ålborg
Denmark	Novo Nordisk Investigational Site	Århus C

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deposition of sterile air depositions.
Secondary	Thickness of 1) dermis and 2) distance from skin surface to muscle fascia
Secondary	Amount of backflow

External Links

•   Clinical Trials at Novo Nordisk