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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014