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Clinical Trial Summary

This study is being conducted to assess the risk of hepatitis B (HepB) diagnosis among diabetes mellitus (DM) and non-DM patients of 0-80 years of age with in a large population-based cohort in United Kingdom (UK) using data from the CPRD database.


Clinical Trial Description

The study is a retrospective, observational, descriptive, cohort study, in DM and non-DM patients of 0-80 years of age. As a first step the eligible baseline population from CPRD will be defined as per the data quality qualifiers, which include subjects aged 0-80 years, "acceptable for research" registered in practices classified as "up to standard" by the CPRD for the time period 2000- 2012. The following cohorts will be defined from the baseline population:

- DM cohort: Patients diagnosed with type 1 or type 2 DM, as confirmed by diagnosis medical codes with or without a DM related drug or monitoring devices prescription.

- Non-DM cohort: Patients with the absence of personal history of DM diagnosis or antidiabetic drug or monitoring devices prescriptions.

From the above defined cohorts, HepB cases will be identified based on clinical diagnosis codes, Hospital Episodes Statistics (HES) or positive diagnostic laboratory tests results. ;


Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


NCT number NCT02324218
Study type Observational
Source GlaxoSmithKline
Contact
Status Completed
Phase N/A
Start date October 2014
Completion date January 2015

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