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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01950637
• Other study ID #: GAPP2
• Secondary ID: U1111-1136-2536
• Status: Completed
• Phase: N/A
• First received: September 23, 2013
• Last updated: January 12, 2017
• Start date: January 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• No treatment given
Completion of 90-item online questionnaire.
• survey
Completion of 58-item online questionnarie.

Locations

Country	Name	City	State
Canada	Novo Nordisk Investigational Site	Mississauga
Denmark	Novo Nordisk Investigational Site	Copenhagen S
Germany	Novo Nordisk Investigational Site	Mainz
Japan	Novo Nordisk Investigational Site	Tokyo
United Kingdom	Novo Nordisk Investigational Site	Crawley
United States	Novo Nordisk Investigational Site	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Germany,  Japan,  United Kingdom, 

References & Publications (2)

Brod M, Rana A, Barnett AH. Adherence patterns in patients with type 2 diabetes on basal insulin analogues: missed, mistimed and reduced doses. Curr Med Res Opin. 2012 Dec;28(12):1933-46. doi: 10.1185/03007995.2012.743458. — View Citation

Brod M, Rana A, Barnett AH. Impact of self-treated hypoglycaemia in type 2 diabetes: a multinational survey in patients and physicians. Curr Med Res Opin. 2012 Dec;28(12):1947-58. doi: 10.1185/03007995.2012.743457. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Level of patient dosing irregularity: missed, mistimed and reduced dose (HCP questionnaire)		Day 1 (when responding to the online questionnaire)
Secondary	Incidence of intentional dosing irregularities and reasons for this behaviour		Day 1 (when responding to the online questionnaire)
Secondary	Impact of dosing irregularity on functional well-being		Day 1 (when responding to the online questionnaire)
Secondary	Frequency of self-treated hypoglycaemia		In the past 30 days prior to the day when responding to the online questionnaire

External Links

•   Clinical Trials at Novo Nordisk