Trial Outcomes & Findings for 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 (NCT NCT04927858)
NCT ID: NCT04927858
Last Updated: 2021-07-22
Results Overview
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.
COMPLETED
460558 participants
Data collected at the index date 31st of December 2017, data covering a time period from 1996 until 2017, up to 21 years.
2021-07-22
Participant Flow
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.
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.
Participant milestones
| Measure |
Overall Type 2 Diabetes Mellitus Population
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.
|
|---|---|
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Overall Study
STARTED
|
460558
|
|
Overall Study
Treated With Empagliflozin
|
16985
|
|
Overall Study
COMPLETED
|
460558
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Overall Type 2 Diabetes Mellitus Population
n=460558 Participants
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.
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|---|---|
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Age, Continuous
|
68.4 Years
STANDARD_DEVIATION 12.3 • n=460558 Participants
|
|
Sex: Female, Male
Female
|
197459 Participants
n=460558 Participants
|
|
Sex: Female, Male
Male
|
263099 Participants
n=460558 Participants
|
PRIMARY outcome
Timeframe: Data collected at the index date 31st of December 2017, data covering a time period from 1996 until 2017, up to 21 years.Population: 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.
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.
Outcome measures
| Measure |
Overall Type 2 Diabetes Mellitus Population
n=460558 Participants
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.
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|---|---|
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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
Without history of CVD
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330050 Participants
|
|
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
With history of CVD
|
130508 Participants
|
PRIMARY outcome
Timeframe: Data collected at the index date 31st of December 2017, data covering a time period from 1996 until 2017, up to 21 years.Population: 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).
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.
Outcome measures
| Measure |
Overall Type 2 Diabetes Mellitus Population
n=16985 Participants
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.
|
|---|---|
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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
With history of CVD
|
1952 Participants
|
|
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
Without history of CVD
|
15033 Participants
|
Adverse Events
Overall Type 2 Diabetes Mellitus Population
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER