N/A
Completed N=460,558
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
Source: ClinicalTrials.gov NCT04927858 ↗Enrolled (actual)
460,558
Serious AEs
—
Results posted
Jul 2021
Primary outcomePrimary: 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 — 130508; 330050 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
130508; 330050 | — |
| 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 |
1952; 15033 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04927858). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.