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Psychosocial Factors Related to Compliance With Treatment With Biphasic Insulin Analogues

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01585506
First Posted: April 26, 2012
Last Update Posted: October 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention
Diabetes Diabetes Mellitus, Type 2 Other: No treatment given

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Psychosocial Factors Related to Compliance With Treatment With Biphasic Insulin Analogues

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 3618
Study Start Date: September 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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"

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes in whom therapy with biphasic insulin analogues was started
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585506


Locations
Poland
Novo Nordisk Investigational Site
Warszawa, Poland, PL-02-274
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01585506     History of Changes
Other Study ID Numbers: BIASP-4018
First Submitted: March 26, 2012
First Posted: April 26, 2012
Last Update Posted: October 31, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs