- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00806858
Observational Study of NovoPen® 4 on Treatment Satisfaction of Insulin Therapy in Type 1 or Type 2 Subjects With Diabetes Mellitus
November 22, 2016 updated by: Novo Nordisk A/S
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
526
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100004
- Novo Nordisk Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Any subject with Type 1 or Type 2 diabetes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
A
|
Insulin administration by means of a NovoPen® 4 pen device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Subjects' device preference
Time Frame: 3 months
|
3 months
|
Subjects' NovoPen® 4 evaluation
Time Frame: 3 months
|
3 months
|
Number of clinical technical complaints
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
December 10, 2008
First Submitted That Met QC Criteria
December 10, 2008
First Posted (Estimate)
December 11, 2008
Study Record Updates
Last Update Posted (Estimate)
November 23, 2016
Last Update Submitted That Met QC Criteria
November 22, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS236-3663
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
AstraZenecaRecruiting
Clinical Trials on NovoPen® 4
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | Diabetes | Diabetes Mellitus, Type 1 | Delivery SystemsItaly, United Kingdom, Austria, Netherlands, Germany
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | Diabetes | Diabetes Mellitus, Type 1 | Delivery SystemsPakistan
-
Novo Nordisk A/SCompletedDiabetes | Diabetes Mellitus, Type 1 | Delivery SystemsIsrael, Canada, Sweden, Finland
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2Germany
-
Radboud University Medical CenterCompleted
-
Radboud University Medical CenterCompleted
-
Revance Therapeutics, Inc.Active, not recruiting
-
Radboud University Medical CenterEuropean Pharma Group (EPG)Completed
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | Diabetes | Diabetes Mellitus, Type 1 | Delivery SystemsDenmark
-
Merz Pharmaceuticals GmbHCompletedSubjects Desiring Lip AugmentationGermany