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NCT01585506 Clinical Trial

Psychosocial Factors Related to Compliance With Treatment With Biphasic Insulin Analogues

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Psychosocial Factors Related to Compliance With Treatment With Biphasic Insulin Analogues

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01585506
Other study ID # BIASP-4018
Secondary ID
Status Completed
Phase N/A
First received March 26, 2012
Last updated February 6, 2018
Start date September 20, 2010
Est. completion date December 20, 2010

Study information
Verified date February 2018
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 3618
Est. completion date December 20, 2010
Est. primary completion date December 20, 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with type 2 diabetes in whom therapy with biphasic insulin analogues was started

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No treatment given
Patients to complete the "WHO-5 Well-being Index" questionnaire
• No treatment given
Physicians to complete two questionnaires, "Demographic Data and Disease and Treatment Course" and "Questionnaire of Potential Difficulties in the Period of Treatment Switching from Insulin to Its Analogues"

Locations
Country Name City State
Poland Novo Nordisk Investigational Site Warszawa

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Poland, 

References & 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.S12 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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