Hypoglycemia: Physician and Patient Perspectives

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01176656
First received: August 4, 2010
Last updated: September 12, 2011
Last verified: September 2011
  Purpose

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.


Condition
Type 2 Diabetes Mellitus
Hypoglycemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Hypoglycemia: Physician and Patient Perspectives

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • prevalence of hypoglycemia and impact of hypoglycemia [ Time Frame: October 2009-October 2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Patient Reported Outcomes of Hypoglycemia (including fear, awareness, behavioral modification and recovery from hypoglycemia) [ Time Frame: October 2009-October 2010 ] [ Designated as safety issue: No ]
  • Treatment adherence and modification related to hypoglycemia, including health status, glycemic control and healthcare utilization [ Time Frame: October 2009-October 2010 ] [ Designated as safety issue: No ]

Enrollment: 800
Study Start Date: September 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176656

Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Director: Setareh Williams, PhD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01176656     History of Changes
Other Study ID Numbers: NIS-CUS-DUM-2010/1
Study First Received: August 4, 2010
Last Updated: September 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by AstraZeneca:
Type 2 Diabetes Mellitus
Hypoglycemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014