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

Boehringer Ingelheim

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Empagliflozin

Study type: Observational

Funder types: Industry

Identifiers

NCT04927858

1245-0190

Details and patient eligibility

About

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

Enrollment: 460,558 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

460,558 participants in 2 patient groups

Population 1

Description:

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.

Population 2

Description:

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).

Treatment:

Drug: Empagliflozin