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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
  Purpose
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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems
Device: NovoPen™ 4
Device: NovoPen® 3
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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

Secondary Outcome Measures:
  • HbA1c
  • Adverse device effects
  • Adverse events

Enrollment: 208
Study Start Date: August 2003
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569998

Locations
Austria
Novo Nordisk Investigational Site
Wien, Austria, 1090
Novo Nordisk Investigational Site
Wien, Austria, A 1090
Germany
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
Italy
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
Netherlands
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
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
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
ClinicalTrials.gov Identifier: NCT00569998     History of Changes
Other Study ID Numbers: MS236-1544
Study First Received: December 4, 2007
Last Updated: January 18, 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

ClinicalTrials.gov processed this record on May 25, 2017