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GAPP 1 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01950650
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Behavioral: No treatment given Behavioral: survey

Study Type : Observational
Actual Enrollment : 1800 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: GAPP 1 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Diabetes Mellitus
Study Start Date : March 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients with diabetes Behavioral: No treatment given
Survey conducted through computer-assisted telephone interviewing.
Physicians Behavioral: survey
Survey conducted via the Internet.



Primary Outcome Measures :
  1. Frequency of insulin omission/non-adherence [ Time Frame: In the past 30 days prior to the day when responding to the survey (patient survey) ]
  2. Reasons for insulin omission/non-adherence reported by patient and physician [ Time Frame: Day 1 (when responding to the survey) ]

Secondary Outcome Measures :
  1. Impact of insulin treatment on life domains (patient survey) [ Time Frame: Day 1 (when responding to the online questionnaire) ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

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): NCT01950650


Locations
United States, New Jersey
Novo Nordisk Investigational Site
Princeton, New Jersey, United States, 08540
China, Beijing
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100004
France
Novo Nordisk Investigational Site
Paris La défense cedex, France, 92932
Germany
Novo Nordisk Investigational Site
Mainz, Germany, 55127
India
Novo Nordisk Investigational Site
Bangalore, India, 560001
Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Russian Federation
Novo Nordisk Investigational Site
Moscow, Russian Federation, 119330
Spain
Novo Nordisk Investigational Site
Madrid, Spain, 28033
Turkey
Novo Nordisk Investigational Site
Istanbul, Turkey, 34335
United Kingdom
Novo Nordisk Investigational Site
Crawley, United Kingdom, RH11 9RT
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01950650     History of Changes
Other Study ID Numbers: GAPP1
U1111-1136-2507 ( Other Identifier: WHO )
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

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