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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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00806858
First received: December 10, 2008
Last updated: July 17, 2012
Last verified: July 2012
History of Changes
  Purpose

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
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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806858

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

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013