Trial · NCT03817463
A Study to Observe the Effectiveness of Empagliflozin, Other SGLT-2 Inhibitors, or DPP-4 Inhibitors in Patients With Type 2 Diabetes
NCT03817463, Completed, Boehringer Ingelheim; results first posted 2024-09-23
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Observe the Effectiveness of Empagliflozin, Other SGLT-2 Inhibitors, or DPP-4 Inhibitors in Patients With Type 2 Diabetes. Trials, record NCT03817463. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03817463
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Observe the Effectiveness of Empagliflozin, Other SGLT-2 Inhibitors, or DPP-4 Inhibitors in Patients With Type 2 Diabetes
- NCT number
- NCT03817463
- Status
- Completed
- Enrollment
- 327,624 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor, Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor
- First posted
- 2019-01-25
- Last updated
- 2024-09-23
- Results first posted
- 2024-09-23
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Hospitalization for Heart Failure (HHF), Broad + Specific Definition | From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i | Number of participants with Hospitalization for Heart Failure (HHF), using broad + specific HHF definition. HHF - broad defined as any diagnosis associated with healthcare encounters, including hospitalizations and specialist outpatient and primary care encounters, or dispensation or any other record of the high-ceiling diuretics (loop diuretics). HHF - specific defined as a primary diagnosis associated with hospital admission. For HHF - broad + specific, HHF-specific definition was used unless only broad definition were available. However, for Japan South Korea and Taiwan, both definitions were available, but broad definition was used. |
| Primary | Number of Participants With Hospitalization for Heart Failure (HHF), Broad Definition | From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i | Reported is the number of participants with hospitalization for heart failure (HHF), using broad definition of HHF. HHF - broad is defined as any diagnosis associated with healthcare encounters, including hospitalizations and specialist outpatient and primary care encounters, or dispensation or any other record of the high-ceiling diuretics (loop diuretics). |
| Primary | Number of Participants With Hospitalization for Heart Failure (HHF), Specific Definition | From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i | Reported is the number of participants with hospitalization for heart failure, using specific definition for HHF. HHF - specific defined as a primary diagnosis associated with hospital admission. |
| Primary | Number of Participants With All-cause Mortality (ACM) | From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. | Number of participants with all-cause mortality (ACM). |
| Primary | Number of Participants With Composite Outcome, Including Hospitalization for Heart Failure (HHF) and All Cause Mortality (ACM) | From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. | Number of participants with composite outcome, including hospitalization for heart failure (HHF) and all cause mortality (ACM). |
| Primary | Number of Participants With Composite Outcome, Including Myocardial Infraction (MI), Stroke and All Cause Mortality (ACM) | From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. | Number of participants with composite outcome, including myocardial infraction (MI), stroke and all cause mortality (ACM). |
| Primary | Number of Participants With Myocardial Infarction (MI) | From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. | Number of participants with myocardial infarction (MI). |
| Primary | Number of Participants With Stroke | From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. | Number of participants with stroke. |
| Secondary | Number of Participants With Cardiovascular Mortality (CM) | From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. | Number of participants with cardiovascular mortality (CM). |
| Secondary | Number of Participants With Composite Outcome Including Hospitalization for Heart Failure (HHF) and Cardiovascular (CV) Mortality | From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. | Number of participants with composite outcome including hospitalization for heart failure (HHF) and cardiovascular (CV) mortality. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Hospitalization for Heart Failure (HHF), Broad + Specific Definition | From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i | All patients included in the study, who were either new user of any SGLT-2i (incl. empagliflozin) or DPP-4i. Results are reported by 1:1 PS-matched cohorts of SGLT-2i/DPP-4i and empagliflozin/DPP-4i. Arms are not mutually exclusive. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Hospitalization for Heart Failure (HHF), Broad Definition | From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i | All patients included in the study, who were either new user of any SGLT-2i (incl. empagliflozin) or DPP-4i. Results are reported by 1:1 PS-matched cohorts of SGLT-2i/DPP-4i and empagliflozin/DPP-4i. Arms are not mutually exclusive. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Hospitalization for Heart Failure (HHF), Specific Definition | From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i | Patients, who were either new user of any SGLT-2i (incl. empagliflozin) or DPP-4i. Results are reported by 1:1 PS-matched cohorts of SGLT-2i/DPP-4i and empagliflozin/DPP-4i. Arms are not mutually exclusive. Country-level results are reported and only include countries with non-missing data or a sufficient number of events to satisfy local patient privacy regulations. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With All-cause Mortality (ACM) | From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. | All patients included in the study, who were either new user of any SGLT-2i (incl. empagliflozin) or DPP-4i. Results are reported by 1:1 PS-matched cohorts of SGLT-2i/DPP-4i and empagliflozin/DPP-4i. Arms are not mutually exclusive. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Composite Outcome, Including Hospitalization for Heart Failure (HHF) and All Cause Mortality (ACM) | From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. | All patients included in the study, who were either new user of any SGLT-2i (incl. empagliflozin) or DPP-4i. Results are reported by 1:1 PS-matched cohorts of SGLT-2i/DPP-4i and empagliflozin/DPP-4i. Arms are not mutually exclusive. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Composite Outcome, Including Myocardial Infraction (MI), Stroke and All Cause Mortality (ACM) | From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. | All patients included in the study, who were either new user of any SGLT-2i (incl. empagliflozin) or DPP-4i. Results are reported by 1:1 PS-matched cohorts of SGLT-2i/DPP-4i and empagliflozin/DPP-4i. Arms are not mutually exclusive. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Myocardial Infarction (MI) | From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. | All patients included in the study, who were either new user of any SGLT-2i (incl. empagliflozin) or DPP-4i. Results are reported by 1:1 PS-matched cohorts of SGLT-2i/DPP-4i and empagliflozin/DPP-4i. Arms are not mutually exclusive. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Stroke | From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. | All patients included in the study, who were either new user of any SGLT-2i (incl. empagliflozin) or DPP-4i. Results are reported by 1:1 PS-matched cohorts of SGLT-2i/DPP-4i and empagliflozin/DPP-4i. Arms are not mutually exclusive. Country-level results are reported and only include countries with non-missing data or a sufficient number of events to satisfy local patient privacy regulations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Cardiovascular Mortality (CM) | From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. | All patients included in the study, who were either new user of any SGLT-2i (incl. empagliflozin) or DPP-4i. Results are reported by 1:1 PS-matched cohorts of SGLT-2i/DPP-4i and empagliflozin/DPP-4i. Arms are not mutually exclusive. Country-level results are reported and only include countries with non-missing data or a sufficient number of events to satisfy local patient privacy regulations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Composite Outcome Including Hospitalization for Heart Failure (HHF) and Cardiovascular (CV) Mortality | From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. | All patients included in the study, who were either new user of any SGLT-2i (incl. empagliflozin) or DPP-4i. Results are reported by 1:1 PS-matched cohorts of SGLT-2i/DPP-4i and empagliflozin/DPP-4i. Arms are not mutually exclusive. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group380
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Hospitalization for Heart Failure (HHF), Broad + Specific Definition | SGLT-2i (Incl. Empa) (Matched to DPP-4i) | 1395 | Participants | ||
| Number of Participants With Hospitalization for Heart Failure (HHF), Broad + Specific Definition | DPP-4i (Matched to SGLT-2i) | 2043 | Participants | ||
| Number of Participants With Hospitalization for Heart Failure (HHF), Broad + Specific Definition | Empagliflozin (Matched to DPP-4i) | 765 | Participants | ||
| Number of Participants With Hospitalization for Heart Failure (HHF), Broad + Specific Definition | DPP-4i (Matched to Empagliflozin) | 1083 | Participants | ||
| Number of Participants With Hospitalization for Heart Failure (HHF), Broad Definition | SGLT-2i (Incl. Empa) (Matched to DPP-4i) | 964 | Participants | ||
| Number of Participants With Hospitalization for Heart Failure (HHF), Broad Definition | DPP-4i (Matched to SGLT-2i) | 1260 | Participants | ||
| Number of Participants With Hospitalization for Heart Failure (HHF), Broad Definition | Empagliflozin (Matched to DPP-4i) | 514 | Participants | ||
| Number of Participants With Hospitalization for Heart Failure (HHF), Broad Definition | DPP-4i (Matched to Empagliflozin) | 641 | Participants | ||
| Number of Participants With Hospitalization for Heart Failure (HHF), Specific Definition | SGLT-2i (Incl. Empa) (Matched to DPP-4i) | Denmark | 273 | Participants | |
| Number of Participants With Hospitalization for Heart Failure (HHF), Specific Definition | DPP-4i (Matched to SGLT-2i) | Denmark | 345 | Participants |
1 to 10 of 380Source ClinicalTrials.gov
See all 380 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SGLT-2i (Incl. Empa) (Matched to DPP-4i) | 163,812 | |
| Overall Study | STARTED | DPP-4i (Matched to SGLT-2i) | 163,812 | |
| Overall Study | COMPLETED | SGLT-2i (Incl. Empa) (Matched to DPP-4i) | 163,812 | |
| Overall Study | COMPLETED | DPP-4i (Matched to SGLT-2i) | 163,812 | |
| Overall Study | NOT COMPLETED | SGLT-2i (Incl. Empa) (Matched to DPP-4i) | 0 | |
| Overall Study | NOT COMPLETED | DPP-4i (Matched to SGLT-2i) | 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 | SGLT-2i (Incl. Empa) (Matched to DPP-4i) | 1,371 | 163,812 |
| Total, all-cause mortality | DPP-4i (Matched to SGLT-2i) | 2,524 | 163,812 |
| Total, other adverse events | SGLT-2i (Incl. Empa) (Matched to DPP-4i) | 0 | 0 |
| Total, other adverse events | DPP-4i (Matched to SGLT-2i) | 0 | 0 |
| Total, serious adverse events | SGLT-2i (Incl. Empa) (Matched to DPP-4i) | 0 | 0 |
| Total, serious adverse events | DPP-4i (Matched to SGLT-2i) | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36097728 | 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 |
|---|
| SGLT-2i (Incl. Empa) (Matched to DPP-4i) vs DPP-4i (Matched to SGLT-2i): 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/NCT03817463
GET https://conductscience.org/api/trials/v1/NCT03817463/registered?page=2