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. Identifier: NCT00569998
Recruitment Status : Completed
First Posted : December 10, 2007
Last Update Posted : January 19, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Delivery Systems Device: NovoPen™ 4 Device: NovoPen® 3 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2003
Actual Primary Completion Date : February 2004
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Evaluation of overall pen preference [ Time Frame: after 12 weeks of treatment ]

Secondary Outcome Measures :
  1. HbA1c
  2. Adverse device effects
  3. Adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00569998

Novo Nordisk Investigational Site
Wien, Austria, 1090
Novo Nordisk Investigational Site
Wien, Austria, A 1090
Novo Nordisk Investigational Site
Köln, Germany, 50858
Novo Nordisk Investigational Site
Leverkusen, Germany, 51373
Novo Nordisk Investigational Site
München, Germany, 81377
Novo Nordisk Investigational Site
Speyer, Germany, 67346
Novo Nordisk Investigational Site
St. Ingbert, Germany, 66386
Novo Nordisk Investigational Site
Völklingen, Germany, 66333
Novo Nordisk Investigational Site
Catania, Italy, 95122
Novo Nordisk Investigational Site
Palermo, Italy, 90127
Novo Nordisk Investigational Site
Parma, Italy, 43100
Novo Nordisk Investigational Site
Roma, Italy, 00165
Novo Nordisk Investigational Site
Torino, Italy, 10144
Novo Nordisk Investigational Site
Almere, Netherlands, 1315 RA
Novo Nordisk Investigational Site
Amsterdam, Netherlands, 1081 HV
Novo Nordisk Investigational Site
Den Haag, Netherlands, 2512 VA
Novo Nordisk Investigational Site
Heerlen, Netherlands, 6419 PC
Novo Nordisk Investigational Site
Rotterdam, Netherlands, 3015 GD
Novo Nordisk Investigational Site
Veldhoven, Netherlands, 5504 DB
United Kingdom
Novo Nordisk Investigational Site
Belfast, United Kingdom, BT12 6BE
Novo Nordisk Investigational Site
Belfast, United Kingdom, BT37 9RH
Novo Nordisk Investigational Site
Leeds, United Kingdom, LS9 7TF
Novo Nordisk Investigational Site
Sidcup, United Kingdom, DA14 6LT
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
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

Responsible Party: Novo Nordisk A/S Identifier: NCT00569998     History of Changes
Other Study ID Numbers: MS236-1544
First Posted: December 10, 2007    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases