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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02324218
• Other study ID #: 201335
• Secondary ID: 14_114
• Status: Completed
• Phase: N/A
• First received: December 11, 2014
• Last updated: July 18, 2016
• Start date: October 2014
• Est. completion date: January 2015

Study information

• Verified date: July 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161429
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Other:
• Data collection
Data extraction from CPRD database of UK.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of new HepB diagnosis among patients between 0-80 years of age previously diagnosed with DM, between 2000 and 2012, in the UK CPRD or Hospital Episodes Statistics (HES).		Up to 12 years	No
Primary	Occurrence of new HepB diagnosis among non-DM patients between 0-80 years of age, in the UK CPRD or HES.		Up to 12 years	No
Secondary	Hospitalisation episode recorded in HES due to HepB infection or complications among patients between 0-80 years of age previously diagnosed with DM and in DM-free (non-DM) patients, in the UK, for whom CPRD-HES linkage is available.		Up to 12 years	No
Secondary	All cause mortality among HepB cases in the DM and DM-free (non-DM) patients between 0-80 years of age, in the UK.		Up to 12 years	No
Secondary	HepB cause-specific mortality among DM and DM-free (non-DM) patients between 0-80 years of age, in the UK for whom CPRD-ONS mortality linkage is available.		Up to 12 years	No
Secondary	New-onset or prevalent HepB diagnosis among new-onset or prevalent DM and DM-free (non-DM) patients between 0-80 years of age, in the UK, regardless of the onset of HepB in relation to the diagnosis of DM.		Up to 12 years	No