Trial · NCT03993132
A Study Using Medical Records of Danish People With Type 2 Diabetes Comparing Empagliflozin and Glucagon-Like Peptide-1 Receptor Agonists (GLP1-RA) in the Occurrence of Serious Cardiovascular Outcomes
NCT03993132, Completed, Boehringer Ingelheim; results first posted 2024-02-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Using Medical Records of Danish People With Type 2 Diabetes Comparing Empagliflozin and Glucagon-Like Peptide-1 Receptor Agonists (GLP1-RA) in the Occurrence of Serious Cardiovascular Outcomes. Trials, record NCT03993132. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03993132
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Using Medical Records of Danish People With Type 2 Diabetes Comparing Empagliflozin and Glucagon-Like Peptide-1 Receptor Agonists (GLP1-RA) in the Occurrence of Serious Cardiovascular Outcomes
- NCT number
- NCT03993132
- Status
- Completed
- Enrollment
- 26,774 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Empagliflozin, Liraglutide
- First posted
- 2019-06-20
- Last updated
- 2024-02-12
- Results first posted
- 2024-02-12
- Limitations and caveats
Due to a huge shift after 2018 in drug type use within the GLP-1RA group the final analysis (between 2015 - 2020) was not completed. Instead, an exploratory analysis was performed, using the initial analysis of comparing from empagliflozin versus liraglutide from 2015 to 2018 but following these same patients up to 2020.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rate of Expanded Major Adverse Cardiovascular Event (MACE) Composite Outcome - OT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | Composite outcome includes: All-cause death, acute admission with non-fatal (within 30 days) stroke, with non-fatal (within 30 days) myocardial infarction (MI), admission with unstable angina, coronary revascularization, or acute admission with non-fatal heart failure (HF). The results from on-treatment (OT) analysis are reported. For the OT analyses, treatment duration was based on the estimated number of days covered by each filled prescription, calculated as the number of drug packages times the numerical volume of a package. A grace period of 30 days were added. In the OT analysis, participants were censored from further follow-up at either treatment cessation, initiation of an alternative drug in the study drug class and initiation of a drug from the comparator study drug class. |
| Primary | Incidence Rate of Expanded Major Adverse Cardiovascular Event (MACE) Composite Outcome - ITT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | Composite outcome includes: All-cause death, acute admission with non-fatal (within 30 days) stroke, with non-fatal (within 30 days) myocardial infarction (MI), admission with unstable angina, coronary revascularization, or acute admission with non-fatal heart failure (HF). The results from intention-to-treat (ITT) analysis are reported. For the ITT analyses, participants were defined as exposed from the start of treatment throughout follow-up, analogous to an ITT design in a interventional trial. Follow-up was not censored if glucose-lowering drugs other than the index drugs were prescribed in addition to empagliflozin or GLP-1RA after the index date. |
| Secondary | Incidence Rate of Heart Failure (HF) Hospitalization or All-cause Death - OT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | The incidence rate of heart failure (HF) hospitalization or all-cause death based on on-treatment (OT) analysis is reported. For the OT analyses, treatment duration was based on the estimated number of days covered by each filled prescription, calculated as the number of drug packages times the numerical volume of a package. A grace period of 30 days were added. In the OT analysis, participants were censored from further follow-up at either treatment cessation, initiation of an alternative drug in the study drug class and initiation of a drug from the comparator study drug class. |
| Secondary | Incidence Rate of Heart Failure (HF) Hospitalization or All-cause Death - ITT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | The incidence rate of heart failure (HF) hospitalization or all-cause death based on Intention-to-treat (ITT) analysis is reported. For the ITT analyses, participants are defined as exposed from the start of treatment throughout follow-up, analogous to an ITT design in a interventional trial. Follow-up was not censored if glucose-lowering drugs other than the index drugs were prescribed in addition to empagliflozin or GLP-1RA after the index date. |
| Secondary | Incidence Rate of First Hospitalized Heart Failure (HHF) or Initiation of Community Prescription Drug Therapy With Loop Diuretics - OT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | The incidence rate of first hospitalized Heart Failure (HHF) or initiation of community prescription drug therapy with loop diuretics based on on-treatment (OT) analysis is reported. For the OT analyses, treatment duration was based on the estimated number of days covered by each filled prescription, calculated as the number of drug packages times the numerical volume of a package. A grace period of 30 days were added. In the OT analysis, participants were censored from further follow-up at either treatment cessation, initiation of an alternative drug in the study drug class and initiation of a drug from the comparator study drug class. |
| Secondary | Incidence Rate of First Hospitalized Heart Failure (HHF) or Initiation of Community Prescription Drug Therapy With Loop Diuretics - ITT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | The incidence rate of first hospitalized Heart Failure (HHF) or initiation of community prescription drug therapy with loop diuretics based on intention-to-treat (ITT) analysis was reported. For the ITT analyses, participants are defined as exposed from the start of treatment throughout follow-up, analogous to an ITT design in a interventional trial. Follow-up was not censored if glucose-lowering drugs other than the index drugs were prescribed in addition to empagliflozin or GLP-1RA after the index date. |
| Secondary | Incidence Rate of All-cause Hospitalization or Death - OT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | Incidence rate of all-cause hospitalization or death, based on on-treatment (OT) analysis is reported. For the OT analyses, treatment duration was based on the estimated number of days covered by each filled prescription, calculated as the number of drug packages times the numerical volume of a package. A grace period of 30 days were added. In the OT analysis, participants were censored from further follow-up at either treatment cessation, initiation of an alternative drug in the study drug class and initiation of a drug from the comparator study drug class. |
| Secondary | Incidence Rate of All-cause Hospitalization or Death - ITT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | Incidence rate of all-cause hospitalization or death, based on intent-to-treat (ITT) analysis. For the ITT analyses, participants were defined as exposed from the start of treatment throughout follow-up, analogous to an ITT design in a interventional trial. Follow-up was not censored if glucose-lowering drugs other than the index drugs were prescribed in addition to empagliflozin or GLP-1RA after the index date. |
| Secondary | Incidence Rate of All Cause Hospitalization - OT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | Incidence rate of all cause hospitalization, based on on-treatment (OT) analysis is reported. For the OT analyses, treatment duration was based on the estimated number of days covered by each filled prescription, calculated as the number of drug packages times the numerical volume of a package. A grace period of 30 days were added. In the OT analysis, participants were censored from further follow-up at either treatment cessation, initiation of an alternative drug in the study drug class and initiation of a drug from the comparator study drug class. |
| Secondary | Incidence Rate of All Cause Hospitalization - ITT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | Incidence rate of all cause hospitalization, based on intent-to-treat (ITT) analysis. For the ITT analyses, participants were defined as exposed from the start of treatment throughout follow-up, analogous to an ITT design in a interventional trial. Follow-up was not censored if glucose-lowering drugs other than the index drugs were prescribed in addition to empagliflozin or GLP-1RA after the index date. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rate of Expanded Major Adverse Cardiovascular Event (MACE) Composite Outcome - OT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users. | Events per 1000 person-years | NUMBER |
| PRIMARY | Incidence Rate of Expanded Major Adverse Cardiovascular Event (MACE) Composite Outcome - ITT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users. | Events per 1000 person-years | NUMBER |
| SECONDARY | Incidence Rate of Heart Failure (HF) Hospitalization or All-cause Death - OT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users. | Events per 1000 person-years | NUMBER |
| SECONDARY | Incidence Rate of Heart Failure (HF) Hospitalization or All-cause Death - ITT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users. | Events per 1000 person-years | NUMBER |
| SECONDARY | Incidence Rate of First Hospitalized Heart Failure (HHF) or Initiation of Community Prescription Drug Therapy With Loop Diuretics - OT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users. | Events per 1000 person-years | NUMBER |
| SECONDARY | Incidence Rate of First Hospitalized Heart Failure (HHF) or Initiation of Community Prescription Drug Therapy With Loop Diuretics - ITT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users. | Events per 1000 person-years | NUMBER |
| SECONDARY | Incidence Rate of All-cause Hospitalization or Death - OT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users. | Events per 1000 patient years | NUMBER |
| SECONDARY | Incidence Rate of All-cause Hospitalization or Death - ITT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users. | Events per 1000 patient years | NUMBER |
| SECONDARY | Incidence Rate of All Cause Hospitalization - OT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users. | Events per 1000 patient years | NUMBER |
| SECONDARY | Incidence Rate of All Cause Hospitalization - ITT Analysis | From first initiation of empagliflozin or liraglutide until end of follow-up, up to 6 years. | All patients included in the propensity score (PS) balanced cohort of either empagliflozin or liraglutide users. | Events per 1000 patient years | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rate of Expanded Major Adverse Cardiovascular Event (MACE) Composite Outcome - OT Analysis | Empagliflozin - PS Balanced Cohort | 36.1 | Events per 1000 person-years | ||
| Incidence Rate of Expanded Major Adverse Cardiovascular Event (MACE) Composite Outcome - OT Analysis | Liraglutide - PS Balanced Cohort | 35.9 | Events per 1000 person-years | ||
| Incidence Rate of Expanded Major Adverse Cardiovascular Event (MACE) Composite Outcome - ITT Analysis | Empagliflozin - PS Balanced Cohort | 39.9 | Events per 1000 person-years | ||
| Incidence Rate of Expanded Major Adverse Cardiovascular Event (MACE) Composite Outcome - ITT Analysis | Liraglutide - PS Balanced Cohort | 37.3 | Events per 1000 person-years | ||
| Incidence Rate of Heart Failure (HF) Hospitalization or All-cause Death - OT Analysis | Empagliflozin - PS Balanced Cohort | 21.1 | Events per 1000 person-years | ||
| Incidence Rate of Heart Failure (HF) Hospitalization or All-cause Death - OT Analysis | Liraglutide - PS Balanced Cohort | 22.2 | Events per 1000 person-years | ||
| Incidence Rate of Heart Failure (HF) Hospitalization or All-cause Death - ITT Analysis | Empagliflozin - PS Balanced Cohort | 25.1 | Events per 1000 person-years | ||
| Incidence Rate of Heart Failure (HF) Hospitalization or All-cause Death - ITT Analysis | Liraglutide - PS Balanced Cohort | 24.3 | Events per 1000 person-years | ||
| Incidence Rate of First Hospitalized Heart Failure (HHF) or Initiation of Community Prescription Drug Therapy With Loop Diuretics - OT Analysis | Empagliflozin - PS Balanced Cohort | 12.9 | Events per 1000 person-years | ||
| Incidence Rate of First Hospitalized Heart Failure (HHF) or Initiation of Community Prescription Drug Therapy With Loop Diuretics - OT Analysis | Liraglutide - PS Balanced Cohort | 18.0 | Events per 1000 person-years |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Empagliflozin - PS Balanced Cohort | 14,148 | |
| Overall Study | STARTED | Liraglutide - PS Balanced Cohort | 12,626 | |
| Overall Study | COMPLETED | Empagliflozin - PS Balanced Cohort | 14,148 | |
| Overall Study | COMPLETED | Liraglutide - PS Balanced Cohort | 12,626 | |
| Overall Study | NOT COMPLETED | Empagliflozin - PS Balanced Cohort | 0 | |
| Overall Study | NOT COMPLETED | Liraglutide - PS Balanced Cohort | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Empagliflozin - PS Balanced Cohort | 881 | 14,148 |
| Total, all-cause mortality | Liraglutide - PS Balanced Cohort | 765 | 12,626 |
| Total, other adverse events | Empagliflozin - PS Balanced Cohort | 0 | 0 |
| Total, other adverse events | Liraglutide - PS Balanced Cohort | 0 | 0 |
| Total, serious adverse events | Empagliflozin - PS Balanced Cohort | 0 | 0 |
| Total, serious adverse events | Liraglutide - PS Balanced Cohort | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36315384 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Empagliflozin - PS Balanced Cohort vs Liraglutide - PS Balanced Cohort: deaths from any cause |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03993132
GET https://conductscience.org/api/trials/v1/NCT03993132/results?page=2