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Evaluating the Use of Two Different Needles in Subjects With Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00569426
First received: December 4, 2007
Last updated: March 26, 2014
Last verified: March 2014

December 4, 2007
March 26, 2014
April 2005
June 2005   (final data collection date for primary outcome measure)
Overall needle preference [ Time Frame: after 2-3 weeks of treatment ] [ Designated as safety issue: No ]
Overall needle preference [ Time Frame: after 2-3 weeks of treatment ]
Complete list of historical versions of study NCT00569426 on ClinicalTrials.gov Archive Site
  • Injection pressure [ Designated as safety issue: No ]
  • Pain perception [ Designated as safety issue: No ]
  • Handling and acceptance of needles [ Designated as safety issue: No ]
  • Injection pressure
  • Pain perception
  • Handling and acceptance of needles
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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
Not Provided

*   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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00569426
NEEDLEN-1637
No
Not Provided
Novo Nordisk A/S
Not Provided
Study Director: Mark Fitch, BSc Novo Nordisk Pharma. Ltd.
Novo Nordisk A/S
March 2014

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