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

An observational study of Type 2 Diabetes Mellitus, run by Boehringer Ingelheim at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Empagliflozin
How many people: 460,558 participants
Where: 1 siteSweden
Study dates: 2 Apr 2018to 15 Nov 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The study population includes patients with T2DM and age ≥18 years on 2017-12-31 and who had at least one registration in the Swedish National Diabetes Register (NDR) between 1996 - 2017.

Who may be able to join

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':

Show all 11Show fewer

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

Who cannot join

none

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Boehringer Ingelheim AB
Stockholm, 120 06

Other trials in Sweden

About this study

Official title: Prevalence of Cardiovascular Disease in Swedish Patients With Type 2 Diabetes and in Patients Initiating on Empagliflozin

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

Conditions: Type 2 Diabetes Mellitus
Being tested: Empagliflozin
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EmpagliflozinDrug
Empagliflozin

Study groups in NCT04927858
Study group	Role	What they receive
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.
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). Receives: Drug: Empagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Apr 201815 Nov 2018

First posted16 Jun 2021
Study start2 Apr 2018
Primary completion15 Nov 2018
Study completion15 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 460,558 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04927858
Sponsor's protocol ID: 1245-0190
Status last verified: Jul 2021
First submitted: 10 Jun 2021
Last updated: 22 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevalence of Cardiovascular Disease in Swedish Patients With Type 2 Diabetes and in Patients Initiating on Empagliflozin
ClinicalTrials.gov ID: NCT04927858
Acronym / sponsor ID: 1245-0190
Conditions: Type 2 Diabetes Mellitus
Study type: Observational
Recruitment status: Completed
Enrolment: 460,558 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 2 Apr 2018 (actual)
Primary completion: 15 Nov 2018 (actual)
Study completion: 15 Nov 2018 (actual)
First posted: 16 Jun 2021 (actual)
Results: Posted 9 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
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.
Population 2	–	Drug: EmpagliflozinPopulation 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study population includes patients with T2DM and age ≥18 years on 2017-12-31 and who had at least one registration in the Swedish National Diabetes Register (NDR) between 1996 - 2017.

Key inclusion criteria (11 listed)

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

Key exclusion criteria (1 listed)

none

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EmpagliflozinEmpagliflozin	Drug	Population 2

Primary outcome

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
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 9 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Type 2 Diabetes Mellitus Population	460,558	460,558

Primary outcome: 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

Time frame: Data collected at the index date 31st of December 2017, data covering a time period from 1996 until 2017, up to 21 years.. Count of participants. Unit: Participants

Measure	Overall Type 2 Diabetes Mellitus Population n = 460558
With history of CVD	130508
Without history of CVD	330050

Population analysed: All 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.

Primary outcome: 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

Time frame: Data collected at the index date 31st of December 2017, data covering a time period from 1996 until 2017, up to 21 years.. Count of participants. Unit: Participants

Measure	Empagliflozin Type 2 Diabetes Mellitus Population n = 16985
With history of CVD	1952
Without history of CVD	15033

Population analysed: All patients with Type 2 Diabetes Mellitus (T2DM) who were initiated on Empagliflozin between 1st of January 2015 to 31st of December 2017, who had at least one registration in the Swedish National Diabetes Register (NDR).

Adverse events

Time frame: Adverse event information was not applicable for this study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall Type 2 Diabetes Mellitus Population	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related infoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets

Related trials for Type 2 Diabetes Mellitus

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Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes Mellitus, run by Boehringer Ingelheim at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Data collected at the index date 31st of December 2017, data covering a time period from 1996 until 2017, up to 21 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04927858.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.