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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

September 23, 2013
January 15, 2014
January 2012
January 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01950637 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
GAPP 2 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Type 2 Diabetes Mellitus
GAPP 2 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Type 2 Diabetes Mellitus

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.

Not Provided
Observational
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample

Insulin treated patients with type 2 diabetes, and HCPs involved in the treatment, management of diabetes and care of patients with type 2 diabetes.

  • Diabetes
  • Diabetes Mellitus, Type 2
  • Behavioral: No treatment given
    Completion of 90-item online questionnaire.
  • Behavioral: survey
    Completion of 58-item online questionnarie.
  • Patients with type 2 diabetes mellitus (T2DM)
    Intervention: Behavioral: No treatment given
  • Healthcare professionals (HCPs)
    Intervention: Behavioral: survey
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4000
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Denmark,   Germany,   Japan,   United Kingdom
 
NCT01950637
GAPP2, U1111-1136-2536
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP