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Psychosocial Factors Related to Compliance With Treatment With Biphasic Insulin Analogues

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01585506
First received: March 26, 2012
Last updated: April 23, 2012
Last verified: April 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01585506

Locations
Poland
Warszawa, Poland, PL-02-274
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Maciej Nazar Novo Nordisk Pharma Sp.z.o.o.
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01585506     History of Changes
Other Study ID Numbers: BIASP-4018
Study First Received: March 26, 2012
Last Updated: April 23, 2012
Health Authority: Poland: Ministry of Health

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

ClinicalTrials.gov processed this record on May 19, 2013