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Evaluating the Use of Two Different Needles in Subjects With Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00569426
First Posted: December 7, 2007
Last Update Posted: January 19, 2017
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
December 4, 2007
December 7, 2007
January 19, 2017
April 2005
June 2005   (Final data collection date for primary outcome measure)
Overall needle preference [ Time Frame: after 2-3 weeks of treatment ]
Same as current
Complete list of historical versions of study NCT00569426 on ClinicalTrials.gov Archive Site
  • Injection pressure
  • Pain perception
  • Handling and acceptance of needles
Same as current
Not Provided
Not Provided
 
Evaluating the Use of Two Different Needles in Subjects With Diabetes
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Delivery Systems
  • Device: NovoFine® needle 6 mm
  • Device: NovoFine® needle 8 mm
Not Provided
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
June 2005
June 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00569426
NEEDLEN-1637
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

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