Hypoglycemia: Physician and Patient Perspectives

NCT01176656 | Completed

• 1 other identifier: NIS-CUS-DUM-2010/1
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus; Hypoglycemia

Keywords

Type 2 Diabetes Mellitus; Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• prevalence of hypoglycemia and impact of hypoglycemia

  October 2009-October 2010

Secondary Outcomes (2)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Type 1 Diabetes Mellitus
• pregnancy or gestational diabetes

Sponsors & Collaborators

• AstraZeneca: lead
• Bristol-Myers Squibb: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Setareh Williams, PhD

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 6, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 13, 2011

Record last verified: 2011-09