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

This study has been completed.

Sponsor:

Information provided by:

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT01024218

First received: November 30, 2009

Last updated: January 25, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 30, 2009

Last Updated Date

January 25, 2012

Start Date ^ICMJE

December 2004

Primary Completion Date

April 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Device preference [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01024218 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open-label, Multicenter, Handling Test and Prospective Cross-over Study on Nurse/Health Assistants Preference Between NovoFine® Autocover™ and 8 mm NovoFine® Needle

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes
Healthcare Professionals
Delivery Systems

Intervention ^ICMJE

Device: NovoFine® needle 8 mm
Device: autocover needle

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2005

Primary Completion Date

April 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01024218

Other Study ID Numbers ^ICMJE

AUTOCOVER

Has Data Monitoring Committee

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Lene Lytzen, DDS

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

January 2012

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

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