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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04927858
Other study ID # 1245-0190
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2, 2018
Est. completion date November 15, 2018

Study information

Verified date July 2021
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 460558
Est. completion date November 15, 2018
Est. primary completion date November 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Empagliflozin
Empagliflozin

Locations

Country Name City State
Sweden Boehringer Ingelheim AB Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of a History of Cardiovascular Disease (CVD) Among Swedish Patients With Type 2 Diabetes Mellitus (T2DM) Who Were Alive on 31st of December 2017 The number of participants with a history of CVD and without a history of CVD among patients who had Type 2 Diabetes Mellitus (T2DM) and were = 18 years old on 31st of December 2017, and were alive on 31st of December 2017, and had at least one registration in the Swedish National Diabetes Registry (NDR) between 1996 - 2017 is reported. History of CVD was defined as a history of either coronary heart disease, stroke, amputation, percutaneous coronary intervention, coronary artery bypass surgery, peripheral vascular disease, or carotid or femoral angioplasty. Data collected at the index date 31st of December 2017, data covering a time period from 1996 until 2017, up to 21 years.
Primary Prevalence of a History of CVD Among Swedish Patients With T2DM Who Started Empagliflozin Treatment Between 1st of January 2015 and 31st of December 2017 The number of participants with a history of CVD and without a history of CVD among 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). History of CVD was defined as a history of either coronary heart disease, stroke, amputation, percutaneous coronary intervention, coronary artery bypass surgery, peripheral vascular disease, or carotid or femoral angioplasty. Data collected at the index date 31st of December 2017, data covering a time period from 1996 until 2017, up to 21 years.
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