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

January 12, 2017 updated by: Novo Nordisk A/S
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Mississauga, Canada, L4W 4XI
        • Novo Nordisk Investigational Site
  • Denmark
      • Copenhagen S, Denmark, 2300
        • Novo Nordisk Investigational Site
  • Germany
      • Mainz, Germany, 55127
        • Novo Nordisk Investigational Site
  • Japan
      • Tokyo, Japan, 1000005
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Crawley, United Kingdom, RH11 9RT
        • Novo Nordisk Investigational Site
  • United States
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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)
Day 1 (when responding to the online questionnaire)

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of intentional dosing irregularities and reasons for this behaviour
Time Frame: Day 1 (when responding to the online questionnaire)
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)
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
In the past 30 days prior to the day when responding to the online questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

September 23, 2013

First Submitted That Met QC Criteria

September 23, 2013

First Posted (ESTIMATE)

September 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAPP2
  • U1111-1136-2536 (OTHER: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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