Evaluating the Use of Two Different Needles in Subjects With Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00569426
First received: December 4, 2007
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems
Device: NovoFine® needle 6 mm
Device: NovoFine® needle 8 mm
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Overall needle preference [ Time Frame: after 2-3 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Injection pressure [ Designated as safety issue: No ]
  • Pain perception [ Designated as safety issue: No ]
  • Handling and acceptance of needles [ Designated as safety issue: No ]

Enrollment: 119
Study Start Date: April 2005
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569426

Locations
United Kingdom
Livingstone, United Kingdom, EH54 6PP
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Mark Fitch, BSc Novo Nordisk Pharma. Ltd.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00569426     History of Changes
Other Study ID Numbers: NEEDLEN-1637
Study First Received: December 4, 2007
Last Updated: March 26, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 23, 2014