NCT02324218

This Study Aims to Determine the Incidence, of Hepatitis B Diagnosis Among Diabetes Mellitus Patients of 0-80 Years of Age

Incidence of Hepatitis B Diagnosis Among Diabetes Mellitus Patients of 0-80 Years of Age, in the United Kingdom Clinical Practice Research Datalink (CPRD)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 161,429 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
OTHER	Data collection	Data extraction from CPRD database of UK.

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-12-24
• Last updated: 2016-07-19