Hypoglycemic Events Following Use of Anti-Diabetic Agents (ADAs)

    Basic Details
    Date Posted
    Wednesday, February 25, 2015
    Status
    Complete
    Medical Product
    anti-diabetic agent (ADA)
    chlorpropamide
    glimepiride
    glipizide
    glipizide/metformin
    glyburide
    glyburide/metformin
    insulin
    metformin
    pioglitazone
    pioglitazone/metformin
    rosiglitazone maleate
    rosiglitazone/metformin
    tolazamide
    Health Outcome(s)
    hypoglycemia
    Description

    Modular program-based one-time assessment assessing hypoglycemic events following use of anti-diabetic agents (ADAs). The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of January 1, 2004 to December 31, 2012. Modular programs are adaptable standardized programs. Results were generated using Modular Program 3, version 6.0; click here for more information.  Queries were distributed in November 2013. This report includes data from 18 Data Partners. Part 1 (MSY5_MPR07_v1_part1) includes results for scenarios 1-17 which do not have a pre-existing dispensing requirement. Results for scenarios 18-30 are presented in Part 2 (MSY5_MPR07_V1_part2) and use different incidence criteria.

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    Additional Details
    FDA Center
    CDER
    Time Period
    2004 - 2012
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)