Hypoglycemia: Physician and Patient Perspectives

September 12, 2011 updated by: AstraZeneca
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

800

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
prevalence of hypoglycemia and impact of hypoglycemia
Time Frame: October 2009-October 2010
October 2009-October 2010

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Bristol-Myers Squibb

Investigators

  • Study Director: Setareh Williams, PhD, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 4, 2010

First Submitted That Met QC Criteria

August 5, 2010

First Posted (Estimate)

August 6, 2010

Study Record Updates

Last Update Posted (Estimate)

September 13, 2011

Last Update Submitted That Met QC Criteria

September 12, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CUS-DUM-2010/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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