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NCT01176656 Clinical Trial

Hypoglycemia: Physician and Patient Perspectives

Type 2 Diabetes Mellitus Clinical Trial

Official title:
Hypoglycemia: Physician and Patient Perspectives

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01176656
Other study ID # NIS-CUS-DUM-2010/1
Secondary ID
Status Completed
Phase N/A
First received August 4, 2010
Last updated September 12, 2011
Start date September 2010
Est. completion date December 2010

Study information
Verified date September 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 800
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
AstraZeneca Bristol-Myers Squibb

Outcome
Type Measure Description Time frame Safety issue
Primary prevalence of hypoglycemia and impact of hypoglycemia October 2009-October 2010 Yes
Secondary Patient Reported Outcomes of Hypoglycemia (including fear, awareness, behavioral modification and recovery from hypoglycemia) October 2009-October 2010 No
Secondary Treatment adherence and modification related to hypoglycemia, including health status, glycemic control and healthcare utilization October 2009-October 2010 No
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