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

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ClinicalTrials.gov Identifier: NCT00806858
Recruitment Status : Completed
First Posted : December 11, 2008
Last Update Posted : November 23, 2016
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Delivery Systems Device: NovoPen® 4

Study Type : Observational
Actual Enrollment : 526 participants
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
Study Start Date : November 2008
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Group/Cohort Intervention/treatment
A Device: NovoPen® 4
Insulin administration by means of a NovoPen® 4 pen device

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Subjects' device preference [ Time Frame: 3 months ]
  2. Subjects' NovoPen® 4 evaluation [ Time Frame: 3 months ]
  3. Number of clinical technical complaints [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00806858

China, Beijing
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100004
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00806858     History of Changes
Other Study ID Numbers: MS236-3663
First Posted: December 11, 2008    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016

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
Hypoglycemic Agents
Physiological Effects of Drugs