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OpenTrials
Completed

NCT Number: NCT01176656

Hypoglycemia: Physician and Patient Perspectives

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. prevalence of hypoglycemia and impact of hypoglycemia

    Time frame: October 2009-October 2010

Secondary outcomes

  1. Patient Reported Outcomes of Hypoglycemia (including fear, awareness, behavioral modification and recovery from hypoglycemia)

    Time frame: October 2009-October 2010

  2. Treatment adherence and modification related to hypoglycemia, including health status, glycemic control and healthcare utilization

    Time frame: October 2009-October 2010

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 6, 2010
Registry last updated
Sep 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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