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

March 30, 2009
January 23, 2012
January 1998
July 1998   (final data collection date for primary outcome measure)
Weighing of reflux of insulin [ Time Frame: 6 seconds after injection ] [ Designated as safety issue: No ]
Weighing of reflux of insulin [ Time Frame: at least 5 seconds after injection ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00872560 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison of 2 NovoFine® Needles on the Reflux of Insulin
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Delivery Systems
  • Device: NovoFine® needle 6 mm
    Other Name: NEEDLEN
  • Device: NovoFine® needle 8 mm
    Other Name: NEEDLEN
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 1998
July 1998   (final data collection date for primary outcome measure)

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
Both
10 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00872560
NEEDLEN/DCD/4/I
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Lene Lytzen, DDS Novo Nordisk A/S
Study Director: Gustavo A. Coronel, MD Novo Nordisk Farmaceutici SpA
Novo Nordisk A/S
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP