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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 (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00569998
First received: December 4, 2007
Last updated: January 18, 2017
Last verified: January 2017

December 4, 2007
January 18, 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
Interventional
Phase 3
Allocation: Randomized
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
  • 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.
 
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
Sexes Eligible for Study: All
9 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Italy,   Netherlands,   United Kingdom
 
 
NCT00569998
MS236-1544
No
Not Provided
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