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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014