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Psychosocial Factors Related to Compliance With Treatment With Biphasic Insulin Analogues

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ClinicalTrials.gov Identifier: NCT01585506
Recruitment Status : Completed
First Posted : April 26, 2012
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief 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.

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

Study Type : Observational
Actual Enrollment : 3618 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Psychosocial Factors Related to Compliance With Treatment With Biphasic Insulin Analogues
Actual Study Start Date : September 20, 2010
Actual Primary Completion Date : December 20, 2010
Actual Study Completion Date : December 20, 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

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"



Primary Outcome Measures :
  1. 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 :
  1. 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 ]


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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

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

Additional Information:
Publications of Results:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01585506     History of Changes
Other Study ID Numbers: BIASP-4018
First Posted: April 26, 2012    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

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