Psychosocial Factors Related to Compliance With Treatment With Biphasic Insulin Analogues

February 6, 2018 updated by: Novo Nordisk A/S
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3618

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warszawa, Poland, PL-02-274
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Questionnaire responders
Other: No treatment given
Patients to complete the "WHO-5 Well-being Index" questionnaire
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"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Up to 3 months
Up to 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Up to 3 months
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2010

Primary Completion (Actual)

December 20, 2010

Study Completion (Actual)

December 20, 2010

Study Registration Dates

First Submitted

March 26, 2012

First Submitted That Met QC Criteria

April 23, 2012

First Posted (Estimate)

April 26, 2012

Study Record Updates

Last Update Posted (Actual)

February 7, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-4018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on No treatment given

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe