NCT00569426|CompletedPhase 4

Evaluating the Use of Two Different Needles in Subjects With Diabetes

An Open-label, Randomised, Multi-centre Cross-over Trial in Diabetes Patients Evaluating Preference, Injection Pressure, Pain Perception and Handling When Injections Are Performed With Two Different Needles i.e. NovoFine® 32 Gauge Tip x 6mm and NovoFine® 30 Gauge x 8mm Using a FlexPen® Disposable Insulin Injection Pen

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

NEEDLEN-1637

Study Type

interventional

Target

119

Locations

1 country

Sites

Timeline

RegisteredDec 2007

StartedApr 2005

CompletionJun 2005

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare two needle types when used with a disposable insulin injection pen in the everyday life setting of an insulin treated patient with diabetes.

Trial Health

On Track

Trial Health Score

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

Enrollment

119

participants targeted

Target at P50-P75 for phase_4 diabetes

Timeline

Completed

Started Apr 2005

Shorter than P25 for phase_4 diabetes

Geographic Reach

1 country

10 active sites

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

2 months study duration

Study Start

First participant enrolled

April 1, 2005

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed

2.5 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2007

Completed

3 days until next milestone

First Posted

Study publicly available on registry

December 7, 2007

Completed

Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

2 months

First QC Date

December 4, 2007

Last Update Submit

January 18, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Delivery Systems

Outcome Measures

Primary Outcomes (1)

Overall needle preference
after 2-3 weeks of treatment

Secondary Outcomes (3)

Injection pressure
Pain perception
Handling and acceptance of needles

Interventions

NovoFine® needle 6 mmDEVICE

NovoFine® needle 8 mmDEVICE

Eligibility Criteria

Age18 Years - 99 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signed and dated informed consent obtained before any trial-related activities
Diagnosed type 1 or type 2 diabetes
Treated with insulin

You may not qualify if:

Previous participation in this trial
Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
Any disease or condition which the investigator feels would interfere with the trial

Contact the study team to confirm eligibility.