Clinical trial NCT01950637: GAPP 2 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Type 2 Diabetes Mellitus
Official title: GAPP 2 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-09-25
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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

Primary outcomes:
measure: Basal insulin dosing irregularities: frequency of missed doses, mistimed doses, or reduced doses (patient questionnaire)
timeFrame: In the past 30 days prior to the day when responding to the online questionnaire
measure: Level of patient dosing irregularity: missed, mistimed and reduced dose (HCP questionnaire)
timeFrame: Day 1 (when responding to the online questionnaire)
Secondary outcomes:
measure: Incidence of intentional dosing irregularities and reasons for this behaviour
timeFrame: Day 1 (when responding to the online questionnaire)
measure: Impact of dosing irregularity on functional well-being
timeFrame: Day 1 (when responding to the online questionnaire)
measure: Frequency of self-treated hypoglycaemia
timeFrame: In the past 30 days prior to the day when responding to the online questionnaire
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Mississauga
country: Canada
facility: Novo Nordisk Investigational Site
city: Copenhagen S
country: Denmark
facility: Novo Nordisk Investigational Site
city: Mainz
country: Germany
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Crawley
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
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. Epub 2012 Nov 14.
citation: 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. Epub 2012 Nov 14.