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Hypoglycemia: Physician and Patient Perspectives

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ClinicalTrials.gov Identifier: NCT01176656
Recruitment Status : Completed
First Posted : August 6, 2010
Last Update Posted : September 13, 2011
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
The purpose of this study is to assess the burden of hypoglycemia and identify unmet need related to the management of hypoglycemia among Type 2Diabetes Mellitus (T2DM) patients on OADs and/or insulin. This is an observational study which will identify patients with T2DM in an administrative claims database and will link claims data with results of patient and physician surveys concerning hypoglycemia.

Condition or disease
Type 2 Diabetes Mellitus Hypoglycemia

Study Design
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Study Type : Observational
Actual Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Hypoglycemia: Physician and Patient Perspectives
Study Start Date : September 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
SU
T2DM patients with a prescription for a sulfonylurea but no insulin
Antidiabetic without SU
T2DM patients with an oral antidiabetic drug other than an SU, and no insulin
Insulin
T2DM patients using insulin, with or without other oral antidiabetics


Outcome Measures
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Primary Outcome Measures :
  1. prevalence of hypoglycemia and impact of hypoglycemia [ Time Frame: October 2009-October 2010 ]

Secondary Outcome Measures :
  1. Patient Reported Outcomes of Hypoglycemia (including fear, awareness, behavioral modification and recovery from hypoglycemia) [ Time Frame: October 2009-October 2010 ]
  2. Treatment adherence and modification related to hypoglycemia, including health status, glycemic control and healthcare utilization [ Time Frame: October 2009-October 2010 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with T2DM will be identified from a large U.S. administrative claims database using a claims-based algorithm for T2DM. Patients and their associated physicians will be recruited via mail into the survey portion of this study. Survey results will be linked to actual patient care using the claims records.
Criteria

Inclusion Criteria:

  • T2DM claims diagnosis (algorithm-based) with at least 2 pharmacy claims for an antidiabetic drug
  • at least 1 HbA1c test recorded during the identification period
  • continuous enrollment in the health plan for at least 12 months prior to survey date

Exclusion Criteria:

  • Type 1 Diabetes Mellitus
  • pregnancy or gestational diabetes
Contacts and Locations
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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): NCT01176656


Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
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Study Director: Setareh Williams, PhD AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01176656    
Other Study ID Numbers: NIS-CUS-DUM-2010/1
First Posted: August 6, 2010    Key Record Dates
Last Update Posted: September 13, 2011
Last Verified: September 2011
Keywords provided by AstraZeneca:
Type 2 Diabetes Mellitus
Hypoglycemia
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases