Comparison of 2 NovoFine® Needles on the Reflux of Insulin

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00872560
First received: March 30, 2009
Last updated: January 23, 2012
Last verified: January 2012
  Purpose

This trial is conducted in Europe. This trial aims to ensure that there is no substantial clinically relevant difference between the two Novo Nordisk needles NovoFine® 6 x 0.30 mm and NovoFine® 8 x 0.30 mm on reflux of insulin back to the surface of cutis.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Delivery Systems
Device: NovoFine® needle 6 mm
Device: NovoFine® needle 8 mm
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Insulin Leakage and Pain Perception in IDDM Children or Adolescents, Where the Injections Are Performed With NovoFine™ 6 x 0.30 mm Needles and NovoFine® 8 x 0.30 mm Needles: An Open, Randomized, Two-period Cross-over, Multi-centre, Phase IIIb Trial at 4 Centres

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Weighing of reflux of insulin [ Time Frame: 6 seconds after injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain perception [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]
  • Number and severity of bleedings [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Reactions at injection sites [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 1998
Study Completion Date: July 1998
Primary Completion Date: July 1998 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: NovoFine® needle 6 mm
    Other Name: NEEDLEN
    Device: NovoFine® needle 8 mm
    Other Name: NEEDLEN
  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children/adolescents with type 1 diabetes mellitus
  • Usage of NovoPen® 1.5 for at least 3 months
  • Duration of insulin treatment more than 1 year
  • Normal weight according to Tanner scales
  • The means of the last 2 HbA1c measurements taken within the last 6 months must be less than 10.5%

Exclusion Criteria:

  • Pregnancy or desire to become pregnant
  • Clinical relevant peripheral neuropathy as judged by the investigators
  • Pronounced lipodystrophy in accordance with investigator's evaluation
  • Use of drugs that can influence the trial
  • Coagulation disorders (use of anti-coagulants)
  • Serious, chronic diseases, making it highly unlikely that the subject can complete the trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872560

Locations
Italy
Chieti, Italy, 66100
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Lene Lytzen, DDS Novo Nordisk A/S
Study Director: Gustavo A. Coronel, MD Novo Nordisk Farmaceutici SpA
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00872560     History of Changes
Other Study ID Numbers: NEEDLEN/DCD/4/I
Study First Received: March 30, 2009
Last Updated: January 23, 2012
Health Authority: Italy: National Institute of Health

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

ClinicalTrials.gov processed this record on April 15, 2014