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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: November 30, 2009
Last updated: February 22, 2017
Last verified: February 2017
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
Intervention Model: Crossover Assignment
Masking: No masking
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 ]

Secondary Outcome Measures:
  • Comparison of the adverse device effects (occlusion/activation/locking problems/manufacturing defects)
  • Comparison of the frequency of adverse device effects
  • Comparison of the frequency of adverse events (needle stick injuries)

Enrollment: 78
Actual Study Start Date: December 1, 2004
Study Completion Date: April 26, 2005
Primary Completion Date: April 26, 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01024218

Novo Nordisk Investigational Site
København, Denmark, 2400
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01024218     History of Changes
Other Study ID Numbers: AUTOCOVER
Study First Received: November 30, 2009
Last Updated: February 22, 2017 processed this record on June 23, 2017