Psychosocial Factors Related to Compliance With Treatment With Biphasic Insulin Analogues
1 other identifier
observational
3,618
1 country
1
Brief Summary
This study is conducted in Europe. The aim of this study is to investigate psychosocial factors related to compliance with treatment with biphasic insulin analogues.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2010
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2010
CompletedFirst Submitted
Initial submission to the registry
March 26, 2012
CompletedFirst Posted
Study publicly available on registry
April 26, 2012
CompletedFebruary 7, 2018
February 1, 2018
3 months
March 26, 2012
February 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency and level of difficulty in introducing changes in compliance with the guidelines for biphasic insulin analogue use in subjects previously treated with biphasic human insulins
Up to 3 months
Secondary Outcomes (1)
Correlations between the difficulty in introducing changes in compliance with the guidelines for biphasic insulin analogue use in subjects previously treated with biphasic human insulins, and psychosocial factors
Up to 3 months
Study Arms (1)
Questionnaire responders
Interventions
Patients to complete the "WHO-5 Well-being Index" questionnaire
Eligibility Criteria
Physicians who switched therapy from biphasic human insulins to a biphasic insulin analogue providing questionnaires for completion to patients whose therapy was switched from biphasic human insulins to biphasic insulin analogues
You may qualify if:
- Patients with type 2 diabetes in whom therapy with biphasic insulin analogues was started
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Warsaw, PL-02-274, Poland
Related Publications (1)
Kokoszka A. Treatment adherence in patients with type 2 diabetes mellitus correlates with different coping styles, low perception of self-influence on disease, and depressive symptoms. Patient Prefer Adherence. 2017 Mar 17;11:587-595. doi: 10.2147/PPA.S124605. eCollection 2017.
PMID: 28360512RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2012
First Posted
April 26, 2012
Study Start
September 20, 2010
Primary Completion
December 20, 2010
Study Completion
December 20, 2010
Last Updated
February 7, 2018
Record last verified: 2018-02