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Comparison of Two Pen Systems in Patients With Diabetes Treated With Insulin

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00569998
First received: December 4, 2007
Last updated: July 17, 2012
Last verified: July 2012

December 4, 2007
July 17, 2012
August 2003
February 2004   (final data collection date for primary outcome measure)
Evaluation of overall pen preference [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
Evaluation of overall pen preference [ Time Frame: after 12 weeks of treatement ]
Complete list of historical versions of study NCT00569998 on ClinicalTrials.gov Archive Site
  • HbA1c [ Designated as safety issue: No ]
  • Adverse device effects [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
  • HbA1c
  • Adverse device effects
  • Adverse events
Not Provided
Not Provided
 
Comparison of Two Pen Systems in Patients With Diabetes Treated With Insulin
An Open-label, Multi-centre, Multi-national, Comparative, Randomised, Cross-over Trial Evaluating Preference as Well as Performance, Acceptance, Handling and Safety of NovoPen™ 4 (MS236) Versus NovoPen 3® in Insulin Treated Diabetic Patients

This trial is conducted in Europe. The aim of this trial is to compare two insulin delivery pens in the everyday life setting of patients with diabetes treated with insulin.

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
  • Diabetes Mellitus, Type 2
  • Delivery Systems
  • Device: NovoPen™ 4
  • Device: NovoPen® 3
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
208
February 2004
February 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 or type 2 diabetes mellitus for at least 12 months
  • Adults at least 18 years
  • Children/adolescents between 9-18 years
  • HbA1c lesser than or equal to 11.0%

Exclusion Criteria:

  • Known or suspected alcohol or drug abuse
  • Patients who are not able to read the user manual (may wear glasses if needed)
  • Hypoglycaemic unawareness as judged by the investigator
  • Visual and/or dexterity impairments as judged by the investigator
Both
9 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Italy,   Netherlands,   United Kingdom
 
NCT00569998
MS236-1544
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
Novo Nordisk A/S
July 2012

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