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

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Behavioral: No treatment given; Behavioral: survey

• Registration Number: NCT01950637
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Study First Submitted: 2013-09-23
• Study First Submitted QC: 2013-09-23
• Study First Posted: 2013-09-25
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4000

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with type 2 diabetes mellitus (T2DM)	No treatment given	-
Healthcare professionals (HCPs)	survey	-

Primary Outcome Measures

Name	Time	Method
Level of patient dosing irregularity: missed, mistimed and reduced dose (HCP questionnaire)	Day 1 (when responding to the online questionnaire)
Basal insulin dosing irregularities: frequency of missed doses, mistimed doses, or reduced doses (patient questionnaire)	In the past 30 days prior to the day when responding to the online questionnaire

Secondary Outcome Measures

Name	Time	Method
Incidence of intentional dosing irregularities and reasons for this behaviour	Day 1 (when responding to the online questionnaire)
Impact of dosing irregularity on functional well-being	Day 1 (when responding to the online questionnaire)
Frequency of self-treated hypoglycaemia	In the past 30 days prior to the day when responding to the online questionnaire

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Crawley, United Kingdom