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GAPP 2 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01950637
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study is conducted Asia, Europe and North America. The aim of this study is to describe insulin therapy adherence and the burden of non-adherence on patient functioning, well-being and diabetes management.

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

Study Type : Observational
Actual Enrollment : 4000 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: GAPP 2 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Type 2 Diabetes Mellitus
Study Start Date : January 2012
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients with type 2 diabetes mellitus (T2DM) Behavioral: No treatment given
Completion of 90-item online questionnaire.
Healthcare professionals (HCPs) Behavioral: survey
Completion of 58-item online questionnarie.



Primary Outcome Measures :
  1. Basal insulin dosing irregularities: frequency of missed doses, mistimed doses, or reduced doses (patient questionnaire) [ Time Frame: In the past 30 days prior to the day when responding to the online questionnaire ]
  2. Level of patient dosing irregularity: missed, mistimed and reduced dose (HCP questionnaire) [ Time Frame: Day 1 (when responding to the online questionnaire) ]

Secondary Outcome Measures :
  1. Incidence of intentional dosing irregularities and reasons for this behaviour [ Time Frame: Day 1 (when responding to the online questionnaire) ]
  2. Impact of dosing irregularity on functional well-being [ Time Frame: Day 1 (when responding to the online questionnaire) ]
  3. Frequency of self-treated hypoglycaemia [ Time Frame: In the past 30 days prior to the day when responding to the online questionnaire ]


Information from the National Library of Medicine

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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 type 2 diabetes, and HCPs involved in the treatment, management of diabetes and care of patients with type 2 diabetes.
Criteria

Inclusion Criteria:

  • PATIENTS WITH T2DM:
  • Diagnosed with type 2 diabetes by a healthcare professional
  • Currently being treated with insulin medication, excluding premix insulin treatment
  • Age at least 40 years
  • Diagnosed as having type 2 diabetes over the age of 40
  • HCPs:
  • Primary care physician, diabetes specialist (diabetologist/endocrinologist) or diabetes specialist nurse/diabetes nurse educator
  • Have a minimum of 2 years experience within current speciality
  • See a minimum of 20 type 2 diabetes patients per month (40 for diabetes specialists), of which at least 10 per month must be on modern (analogue) inulins

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): NCT01950637


Locations
United States, New Jersey
Novo Nordisk Investigational Site
Princeton, New Jersey, United States, 08540
Canada
Novo Nordisk Investigational Site
Mississauga, Canada, L4W 4XI
Denmark
Novo Nordisk Investigational Site
Copenhagen S, Denmark, 2300
Germany
Novo Nordisk Investigational Site
Mainz, Germany, 55127
Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
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:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01950637     History of Changes
Other Study ID Numbers: GAPP2
U1111-1136-2536 ( Other Identifier: WHO )
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017

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