- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01950650
GAPP 1 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Diabetes Mellitus
April 25, 2017 updated by: Novo Nordisk A/S
This study is conducted in Asia, Europe and in the United States of America.
The aim of this study is to examine patient and physician beliefs regarding insulin therapy and the degree to which patients adhere to their insulin regimens.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1800
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
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Beijing
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Beijing, Beijing, China, 100004
- Novo Nordisk Investigational Site
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Paris La défense cedex, France, 92932
- Novo Nordisk Investigational Site
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Mainz, Germany, 55127
- Novo Nordisk Investigational Site
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Bangalore, India, 560001
- Novo Nordisk Investigational Site
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Tokyo, Japan, 1000005
- Novo Nordisk Investigational Site
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Moscow, Russian Federation, 119330
- Novo Nordisk Investigational Site
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Madrid, Spain, 28033
- Novo Nordisk Investigational Site
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Istanbul, Turkey, 34335
- Novo Nordisk Investigational Site
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Crawley, United Kingdom, RH11 9RT
- Novo Nordisk Investigational Site
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New Jersey
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Princeton, New Jersey, United States, 08540
- Novo Nordisk Investigational Site
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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
Probability Sample
Study Population
Insulin treated patients with diabetes (type 1 or 2), and physicians involved in the treatment, management of diabetes and care of patients with diabetes.
Description
Inclusion Criteria:
- PATIENTS WITH DIABETES:
- Age 18 years or older
- Treated with insulin
- Type 1 or Type 2 diabetes
- PHYSICIANS:
- In practice for more than 1 year since completing residency
- See a minimum number of patients with diabetes per week (primary care physicians 5, specialists 10)
- Initiate insulin treatment for patients with diabetes
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
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Patients with diabetes
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Survey conducted through computer-assisted telephone interviewing.
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Physicians
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Survey conducted via the Internet.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Frequency of insulin omission/non-adherence
Time Frame: In the past 30 days prior to the day when responding to the survey (patient survey)
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In the past 30 days prior to the day when responding to the survey (patient survey)
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Reasons for insulin omission/non-adherence reported by patient and physician
Time Frame: Day 1 (when responding to the survey)
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Day 1 (when responding to the survey)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Impact of insulin treatment on life domains (patient survey)
Time Frame: Day 1 (when responding to the online questionnaire)
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Day 1 (when responding to the online questionnaire)
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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
March 1, 2010
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
September 23, 2013
First Submitted That Met QC Criteria
September 23, 2013
First Posted (Estimate)
September 25, 2013
Study Record Updates
Last Update Posted (Actual)
April 27, 2017
Last Update Submitted That Met QC Criteria
April 25, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GAPP1
- U1111-1136-2507 (Other Identifier: WHO)
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.
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