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
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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). |
Drug: Empagliflozin
Empagliflozin
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
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' :
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Diagnosed with T2DM in Sweden
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Alive on 31 December 2017
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At least one registration in the Swedish National Diabetes Register (NDR)
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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':
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Diagnosed with T2DM in Sweden
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Alive on 31 December 2017
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Initiated on empagliflozin between 1 January 2015 and 31 December 2017
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At least one registration in the NDR
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Each patient provides informed consent for inclusion in the register
Exclusion criteria:
none
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Boehringer Ingelheim AB | Stockholm | Sweden | 120 06 |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 1245-0190
Study Results
Participant Flow
Recruitment Details | This retrospective study assessed the prevalence of cardiovascular disease in Swedish patients with type 2 diabetes mellitus (T2DM) and in Swedish patients with T2DM initiating on empagliflozin. |
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Pre-assignment Detail | This study was conducted using data collected from the Swedish National Diabetes Register (NDR) as well as the Swedish Prescribed Drug Register (SPDR) and the Swedish National Patient Register (NPR) (National Board of Health and Welfare). The observation period was from 1996 to end of December 2017. |
Arm/Group Title | Overall Type 2 Diabetes Mellitus Population |
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Arm/Group Description | This arm included 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. |
Period Title: Overall Study | |
STARTED | 460558 |
Treated With Empagliflozin | 16985 |
COMPLETED | 460558 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | Overall Type 2 Diabetes Mellitus Population |
---|---|
Arm/Group Description | This arm included 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. |
Overall Participants | 460558 |
Age (Years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Years] |
68.4
(12.3)
|
Sex: Female, Male (Count of Participants) | |
Female |
197459
42.9%
|
Male |
263099
57.1%
|
Race and Ethnicity Not Collected (Count of Participants) |
Outcome Measures
Title | 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 |
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Description | 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. |
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. |
Outcome Measure Data
Analysis Population Description |
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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. |
Arm/Group Title | Overall Type 2 Diabetes Mellitus Population |
---|---|
Arm/Group Description | This arm included 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. |
Measure Participants | 460558 |
With history of CVD |
130508
28.3%
|
Without history of CVD |
330050
71.7%
|
Title | 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 |
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Description | 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. |
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. |
Outcome Measure Data
Analysis Population Description |
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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). |
Arm/Group Title | Empagliflozin Type 2 Diabetes Mellitus Population |
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Arm/Group Description | 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). |
Measure Participants | 16985 |
With history of CVD |
1952
0.4%
|
Without history of CVD |
15033
3.3%
|
Adverse Events
Time Frame | Adverse event information was not applicable for this study. | |
---|---|---|
Adverse Event Reporting Description | As this is a non-interventional study with secondary use of data retrieved from Swedish Databases safety monitoring and safety reporting on an individual case level is not applicable. All-Cause Mortality, Serious Adverse Events and Other Adverse Events are not collected in the database. "0" total Number of Participants at Risk means "All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed". | |
Arm/Group Title | Overall Type 2 Diabetes Mellitus Population | |
Arm/Group Description | This arm included 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. | |
All Cause Mortality |
||
Overall Type 2 Diabetes Mellitus Population | ||
Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | |
Serious Adverse Events |
||
Overall Type 2 Diabetes Mellitus Population | ||
Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | |
Other (Not Including Serious) Adverse Events |
||
Overall Type 2 Diabetes Mellitus Population | ||
Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Name/Title | Boehringer Ingelheim, Call Center |
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Organization | Boehringer Ingelheim |
Phone | 1-800-243-0217 |
clinicaltriage.rdg@boehringer-ingelheim.com |
- 1245-0190