Hypoglycemia: Physician and Patient Perspectives

Completed

• Conditions: Type 2 Diabetes Mellitus; Hypoglycemia

• Registration Number: NCT01176656
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-04
• Study First Submitted QC: 2010-08-05
• Study First Posted: 2010-08-06
• Study Start: 2010-09
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-12
• Last Update Posted: 2011-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prevalence of hypoglycemia and impact of hypoglycemia	October 2009-October 2010

Secondary Outcome Measures

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