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OpenTrials
Completed

NCT Number: NCT00569426

Evaluating the Use of Two Different Needles in Subjects With Diabetes

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Delivery Systems Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Cambridge, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NovoFine® needle 6 mm

Device

NovoFine® needle 8 mm

Device

Primary outcomes

  1. Overall needle preference

    Time frame: after 2-3 weeks of treatment

Secondary outcomes

  1. Injection pressure

  2. Pain perception

  3. Handling and acceptance of needles

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Dec 7, 2007
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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