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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01950650
First received: September 23, 2013
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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 Intervention
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Behavioral: No treatment given
Behavioral: survey

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Frequency of insulin omission/non-adherence [ Time Frame: In the past 30 days prior to the day when responding to the survey (patient survey) ] [ Designated as safety issue: No ]
  • Reasons for insulin omission/non-adherence reported by patient and physician [ Time Frame: Day 1 (when responding to the survey) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact of insulin treatment on life domains (patient survey) [ Time Frame: Day 1 (when responding to the online questionnaire) ] [ Designated as safety issue: No ]

Enrollment: 1800
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with diabetes Behavioral: No treatment given
Survey conducted through computer-assisted telephone interviewing.
Physicians Behavioral: survey
Survey conducted via the Internet.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01950650

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

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01950650     History of Changes
Other Study ID Numbers: GAPP1, U1111-1136-2507
Study First Received: September 23, 2013
Last Updated: January 15, 2014
Health Authority: China: Ministry of Health
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
India: Ministry of Health
Japan: Ministry of Health, Labor and Welfare
Russia: Ministry of Health of the Russian Federation
Spain: Ministry of Health
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 22, 2014