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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01950637
First received: September 23, 2013
Last updated: January 12, 2017
Last verified: January 2017
  Purpose
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 Intervention
Diabetes
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 2 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Type 2 Diabetes Mellitus

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

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

Enrollment: 4000
Study Start Date: January 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

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
  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: 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
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01950637     History of Changes
Other Study ID Numbers: GAPP2  U1111-1136-2536 
Study First Received: September 23, 2013
Last Updated: January 12, 2017

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

ClinicalTrials.gov processed this record on February 17, 2017