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

Phase 4

Completed

• Conditions: Diabetes; Delivery Systems; Healthcare Professionals

• Registration Number: NCT01024218
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-12-01
• Primary Completion: 2005-04-26
• Study Completion: 2005-04-26
• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Device preference	after 12 weeks

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇰 København, Denmark