NCT01024218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2005

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

November 30, 2009

Last Update Submit

February 22, 2017

Conditions

DiabetesHealthcare ProfessionalsDelivery Systems

Outcome Measures

Primary Outcomes (1)

  • Device preference

    after 12 weeks

Secondary Outcomes (3)

  • 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)

Interventions

NovoFine® needle 8 mmDEVICE
autocover needleDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Copenhagen, 2400, Denmark

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 2, 2009

Study Start

December 1, 2004

Primary Completion

April 26, 2005

Study Completion

April 26, 2005

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

DK(1)