Preference Study Between NovoFine® Autocover™ and a NovoFine® 8 mm Needle

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01024218
First received: November 30, 2009
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

This trial is conducted in Europe. The aim of this clinical trial is to assess the preference of 2 different needles used by nurses and health assistants. The trial consists of a handling test followed by a 12 week cross-over study.


Condition Intervention Phase
Diabetes
Healthcare Professionals
Delivery Systems
Device: NovoFine® needle 8 mm
Device: autocover needle
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter, Handling Test and Prospective Cross-over Study on Nurse/Health Assistants Preference Between NovoFine® Autocover™ and 8 mm NovoFine® Needle

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Device preference [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of the adverse device effects (occlusion/activation/locking problems/manufacturing defects) [ Designated as safety issue: Yes ]
  • Comparison of the frequency of adverse device effects [ Designated as safety issue: Yes ]
  • Comparison of the frequency of adverse events (needle stick injuries) [ Designated as safety issue: Yes ]

Enrollment: 78
Study Start Date: December 2004
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The participant must have been either a diabetes nurse or a diabetes health assistant with competence in subcutaneous injections of insulin for at least 4 weeks
  • Participants must demonstrate proficiency with the injection device in the handling test prior to testing the NovoFine® Autocover™ Needle in patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024218

Locations
Denmark
København, Denmark, 2400
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Lene Lytzen, DDS Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01024218     History of Changes
Other Study ID Numbers: AUTOCOVER
Study First Received: November 30, 2009
Last Updated: January 25, 2012
Health Authority: Denmark: Danish Medicines Agency

ClinicalTrials.gov processed this record on April 17, 2014