Hypoglycemia: Physician and Patient Perspectives

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

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 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

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
T2DM patients using insulin, with or without other oral antidiabetics

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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

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

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 identifier (NCT number): NCT01176656

Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Setareh Williams, PhD AstraZeneca

Responsible Party: AstraZeneca Identifier: NCT01176656     History of Changes
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

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