A Study Using Swedish Registries to Find Out How Many People With Type 2 Diabetes Had Cardiovascular Disease and Started Treatment With Empagliflozin Between 2015 and 2017

NCT ID: NCT04927858

Last Updated: 2021-07-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

460558 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-02

Study Completion Date

2018-11-15

Brief Summary

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This study aims to describe the prevalence of type 2 diabetes mellitus (T2DM) patients with established cardiovascular disease (CVD) according to the (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME (ERO)) study definition in a Swedish population.

The aim was also to describe the prevalence of established CVD according to ERO study definition in patients with T2DM who initiates treatment with empagliflozin

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Population 1

Patients ≥ 18 years old on 31st of December 2017 with Type 2 Diabetes Mellitus (T2DM) who were alive on 31st of December 2017 and had at least one registration in the Swedish National Diabetes Registry (NDR) between 1996 - 2017.

No interventions assigned to this group

Population 2

Population 2 is a sub-population of population 1. Patients with Type 2 Diabetes Mellitus (T2DM) who were initiated on Empagliflozin between 1st of January 2015 and 31st of December 2017, who had at least one registration in the Swedish National Diabetes Register (NDR).

Empagliflozin

Intervention Type DRUG

Empagliflozin

Interventions

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Empagliflozin

Empagliflozin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Population 1: 'Prevalence of a history of cardiovascular disease (CVD) among persons with type 2 diabetes mellitus (T2DM) who were alive on 31 December 2017' :

* Diagnosed with T2DM in Sweden
* Alive on 31 December 2017
* At least one registration in the Swedish National Diabetes Register (NDR)
* Each patient provides informed consent for inclusion in the register

Population 2: 'Prevalence of a history of CVD among persons with type 2 diabetes who started empagliflozin treatment between 1 January 2015 and 31 December 2017':

* Diagnosed with T2DM in Sweden
* Alive on 31 December 2017
* Initiated on empagliflozin between 1 January 2015 and 31 December 2017
* At least one registration in the NDR
* Each patient provides informed consent for inclusion in the register

Exclusion Criteria

none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Boehringer Ingelheim AB

Stockholm, , Sweden

Site Status

Countries

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Sweden

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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1245-0190

Identifier Type: -

Identifier Source: org_study_id

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