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

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Empagliflozin

• Registration Number: NCT04927858
• Lead Sponsor: Boehringer Ingelheim

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-02
• Primary Completion: 2018-11-15
• Study Completion: 2018-11-15
• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-10
• Study First Posted: 2021-06-16
• Results First Submitted: 2021-06-16
• Results First Submitted QC: 2021-06-16
• Status Verified: 2021-07
• Results First Posted: 2021-07-09
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460558

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Population 2	Empagliflozin	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).

Primary Outcome Measures

Name	Time	Method
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	Data collected at the index date 31st of December 2017, data covering a time period from 1996 until 2017, up to 21 years.	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.
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	Data collected at the index date 31st of December 2017, data covering a time period from 1996 until 2017, up to 21 years.	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.

Trial Locations

Locations (1)

Boehringer Ingelheim AB; 🇸🇪 Stockholm, Sweden