Psychosocial Factors Related to Compliance With Treatment With Biphasic Insulin Analogues

NCT ID: NCT01585506

Last Updated: 2018-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3618 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-20

Study Completion Date

2010-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Questionnaire responders

No treatment given

Intervention Type OTHER

Patients to complete the "WHO-5 Well-being Index" questionnaire

No treatment given

Intervention Type OTHER

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"

Interventions

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No treatment given

Patients to complete the "WHO-5 Well-being Index" questionnaire

Intervention Type OTHER

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"

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with type 2 diabetes in whom therapy with biphasic insulin analogues was started
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Warsaw, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type RESULT
PMID: 28360512 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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BIASP-4018

Identifier Type: -

Identifier Source: org_study_id

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