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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00569426
Enrollment
119
Registered
2007-12-07
Start date
2005-04-30
Completion date
2005-06-30
Last updated
2017-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Overall needle preferenceafter 2-3 weeks of treatment

Secondary

MeasureTime frame
Injection pressure
Pain perception
Handling and acceptance of needles

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026