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 15, 2014
Last verified: January 2014
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
  • Level of patient dosing irregularity: missed, mistimed and reduced dose (HCP questionnaire) [ Time Frame: Day 1 (when responding to the online questionnaire) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of intentional dosing irregularities and reasons for this behaviour [ Time Frame: Day 1 (when responding to the online questionnaire) ] [ Designated as safety issue: No ]
  • Impact of dosing irregularity on functional well-being [ Time Frame: Day 1 (when responding to the online questionnaire) ] [ Designated as safety issue: No ]
  • Frequency of self-treated hypoglycaemia [ Time Frame: In the past 30 days prior to the day when responding to the online questionnaire ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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 Clinical Trial Call Center
Princeton, New Jersey, United States, 08540
Canada
Mississauga, Canada, L4W 4XI
Denmark
Copenhagen S, Denmark, 2300
Germany
Mainz, Germany, 55127
Japan
Tokyo, Japan, 1000005
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: NCT01950637     History of Changes
Other Study ID Numbers: GAPP2, U1111-1136-2536
Study First Received: September 23, 2013
Last Updated: January 15, 2014
Health Authority: Canada: Health Canada
Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Japan: Ministry of Health, Labor and Welfare
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014