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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00569998
Recruitment Status : Completed
First Posted : December 10, 2007
Last Update Posted : January 19, 2017
Information provided by (Responsible Party):

December 4, 2007
December 10, 2007
January 19, 2017
August 2003
February 2004   (Final data collection date for primary outcome measure)
Evaluation of overall pen preference [ Time Frame: after 12 weeks of treatment ]
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
  • Adverse device effects
  • Adverse events
Same as current
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
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Delivery Systems
  • Device: NovoPen™ 4
  • Device: NovoPen® 3
Not Provided
  • Kolaczynski M, Chayer D. NovoPen® 4: perceived as superior in handling and acceptance versus HumaPen® Ergo and OptiPen® Pro in patients and healthcare professionals. Diabetes Technology & Therapeutics 2005; 7 (2): 390
  • Goke B, Gamba S, Erdtsieck RJ, Gilbey S, Schober E, Lytzen L, Kolaczynski M. NovoPen 4 offers superior performance, handling and acceptance compared with NovoPen 3 in insulin-treated diabetes patients. Diabetes Technology and Therapeutics 2005; 7 (2): 379-380

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
9 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Italy,   Netherlands,   United Kingdom
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

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