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
• 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

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypoglycemia
• Type 2 Diabetes Mellitus

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