Evaluating the Use of Two Different Needles in Subjects With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00569426
Recruitment Status : Completed
First Posted : December 7, 2007
Last Update Posted : January 19, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Delivery Systems Device: NovoFine® needle 6 mm Device: NovoFine® needle 8 mm Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2005
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Overall needle preference [ Time Frame: after 2-3 weeks of treatment ]

Secondary Outcome Measures :
  1. Injection pressure
  2. Pain perception
  3. Handling and acceptance of needles

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00569426

United Kingdom
Novo Nordisk Investigational Site
Cambridge, United Kingdom, CB2 2QQ
Novo Nordisk Investigational Site
Cardiff, United Kingdom, CF14 4XW
Novo Nordisk Investigational Site
Church Village, United Kingdom, CF38 1AB
Novo Nordisk Investigational Site
Dundee, United Kingdom, DD1 9SY
Novo Nordisk Investigational Site
Haywards Heath, United Kingdom, RH16 4EX
Novo Nordisk Investigational Site
Liverpool, United Kingdom, L9 7AL
Novo Nordisk Investigational Site
Livingstone, United Kingdom, EH54 6PP
Novo Nordisk Investigational Site
Penarth, United Kingdom, CF64 2XX
Novo Nordisk Investigational Site
Plymouth, United Kingdom, PL8 8DQ
Novo Nordisk Investigational Site
Sheffield, United Kingdom, S5 7AU
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
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

Responsible Party: Novo Nordisk A/S Identifier: NCT00569426     History of Changes
Other Study ID Numbers: NEEDLEN-1637
First Posted: December 7, 2007    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases