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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Hepatitis B

Treatments: Other: Data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT02324218

201335

14_114 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 161,429 patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects, 0 to 80 years of age during the study period.

• Subjects acceptable for research as per CPRD definition:

  • Acceptable flag for research.

• Subjects with at least 12 months of observation time at the time of inclusion in the study:

  • Subjects have to be registered in the CPRD database for at least 12 months at the date of inclusion in the study.
  • Subjects have to be registered in a general practitioner practice classified as 'up to standard' for at least 12 months at the date of inclusion in the study.

• Particular Case of New Born Children.

  • To ensure inclusion of subjects less than 1 year of age, they will be included regardless their observation time in CPRD.

• Inclusion Date

  • Inclusion criteria will be assessed for each calendar year between the Years 2000 and 2012.

Exclusion criteria

• For the analyses requiring the inclusion of HES data, HES records linked with more than one CPRD patient will be excluded from the analyses.

Trial design

161,429 participants in 2 patient groups

Diabetes mellitus Group

Description:

All the subjects with diabetes mellitus diagnosed with hepatitis B, reported in the CPRD database of UK, from the Year 2000 to 2012.

Treatment:

Other: Data collection

Non-Diabetes mellitus Group

Description:

All the subjects with hepatitis B who are diagnosed negative diabetes mellitus, reported in the CPRD database of UK, from the Year 2000 to 2012.

Treatment:

Other: Data collection