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NCT00569426 Clinical Trial

Evaluating the Use of Two Different Needles in Subjects With Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
An Open-label, Randomised, Multi-centre Cross-over Trial in Diabetes Patients Evaluating Preference, Injection Pressure, Pain Perception and Handling When Injections Are Performed With Two Different Needles i.e. NovoFine® 32 Gauge Tip x 6mm and NovoFine® 30 Gauge x 8mm Using a FlexPen® Disposable Insulin Injection Pen

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00569426
Other study ID # NEEDLEN-1637
Secondary ID
Status Completed
Phase Phase 4
First received December 4, 2007
Last updated January 18, 2017
Start date April 2005
Est. completion date June 2005

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this trial is to compare two needle types when used with a disposable insulin injection pen in the everyday life setting of an insulin treated patient with diabetes.

Recruitment information / eligibility
Status Completed
Enrollment 119
Est. completion date June 2005
Est. primary completion date June 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- Signed and dated informed consent obtained before any trial-related activities

- Diagnosed type 1 or type 2 diabetes

- Treated with insulin

Exclusion Criteria:

- Previous participation in this trial

- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation

- Any disease or condition which the investigator feels would interfere with the trial

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• NovoFine® needle 6 mm

• NovoFine® needle 8 mm

Locations
Country Name City State
United Kingdom Novo Nordisk Investigational Site Cambridge
United Kingdom Novo Nordisk Investigational Site Cardiff
United Kingdom Novo Nordisk Investigational Site Church Village
United Kingdom Novo Nordisk Investigational Site Dundee
United Kingdom Novo Nordisk Investigational Site Haywards Heath
United Kingdom Novo Nordisk Investigational Site Liverpool
United Kingdom Novo Nordisk Investigational Site Livingstone
United Kingdom Novo Nordisk Investigational Site Penarth
United Kingdom Novo Nordisk Investigational Site Plymouth
United Kingdom Novo Nordisk Investigational Site Sheffield

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

McKay M, Compion G, Lytzen L. Pain Perception, Patient Preference, Injection Pressure and Handling with NovoFine® 32G x 6mm Versus 30G x 8mm Needle. ADA 2006; : 1968-PO

Outcome
Type Measure Description Time frame Safety issue
Primary Overall needle preference after 2-3 weeks of treatment
Secondary Injection pressure
Secondary Pain perception
Secondary Handling and acceptance of needles
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