Observational Study of NovoPen® 4 on Treatment Satisfaction of Insulin Therapy in Type 1 or Type 2 Subjects With Diabetes Mellitus

This study has been completed.
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
First received: December 10, 2008
Last updated: July 17, 2012
Last verified: July 2012
This study is conducted in Asia. The aim of this observational study is to evaluate subjects' treatment satisfaction and to evaluate subjects' preference of pen device and the incidence of clinical technical complains while using NovoPen® 4 under normal clinical practice conditions.

Condition Intervention
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems
Device: NovoPen® 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: NovoPen®4 Clinical Experience Programme: A Multicentre, Observational Study of NovoPen®4 on Treatment Satisfaction of Insulin Therapy in Type 1 or Type 2 Subjects With Diabetes Mellitus

Resource links provided by NLM:

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

Primary Outcome Measures:
  • The change in subjects' satisfaction with insulin therapy, measured by change from visit 1 to visit 2 in subject treatment satisfaction scores on the DTSQ (Diabetes Treatment Satisfaction Questionnaire) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjects' device preference [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Subjects' NovoPen® 4 evaluation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of clinical technical complaints [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 526
Study Start Date: November 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Device: NovoPen® 4
Insulin administration by means of a NovoPen® 4 pen device


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any subject with Type 1 or Type 2 diabetes

Inclusion Criteria:

  • Any subject with Type 1 or Type 2 diabetes and accepting to use NovoPen® 4. The selection will be at the discretion of the individual physician.
  • A study specific signed informed consent must be signed by each subject before any study-related activities or information is collected, if required by local regulations

Exclusion Criteria:

  • Subjects who are unlikely to comply with the protocol, e.g., unwillingness to cooperate, inability to return for the final visit
  • Subjects with known or suspected allergy to any insulin or any of its excipients
  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: NCT00806858

China, Beijing
Beijing, Beijing, China, 100004
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Zhang Qi Novo Nordisk (China) Pharmaceuticals Co., Ltd.
  More Information

Additional Information:
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00806858     History of Changes
Other Study ID Numbers: MS236-3663 
Study First Received: December 10, 2008
Last Updated: July 17, 2012
Health Authority: China: Ministry of Health

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

ClinicalTrials.gov processed this record on May 24, 2016