Who is sponsoring NCT03817463?

NCT03817463 is sponsored by Boehringer Ingelheim.

What condition does NCT03817463 study?

NCT03817463 studies Diabetes Mellitus, Type 2.

Is NCT03817463 still recruiting?

NCT03817463 is currently completed. Last updated 23 September 2024.

Are results published for NCT03817463?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-09-23 · How we verify

NCT03817463

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Observe the Effectiveness of Empagliflozin, Other SGLT-2 Inhibitors, or DPP-4 Inhibitors in Patients With Type 2 Diabetes

Completed Results posted Last updated 23 September 2024

What this trial tests

trial testing Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor in Diabetes Mellitus, Type 2 in 327,624 participants. Completed in 10 December 2021.

Timeline

15 April 2019

Primary endpoint
10 December 2021

10 December 2021

Quick facts

Lead sponsor	Boehringer Ingelheim
Status	Completed
Study type	OBSERVATIONAL
Enrollment	327,624
Start date	15 April 2019
Primary completion	10 December 2021
Estimated completion	10 December 2021
Sites	13 locations across Denmark, Japan, Finland, Sweden, Taiwan, United Kingdom, Israel, Germany

Drugs / interventions tested

Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor — full drug profile →
Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor — full drug profile →

Conditions studied

Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Hospitalization for Heart Failure (HHF), Broad + Specific Definition Primary · 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

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	1395
DPP-4i (Matched to SGLT-2i)	2043
Empagliflozin (Matched to DPP-4i)	765
DPP-4i (Matched to Empagliflozin)	1083

Number of Participants With Hospitalization for Heart Failure (HHF), Broad Definition Primary · 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).

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	964
DPP-4i (Matched to SGLT-2i)	1260
Empagliflozin (Matched to DPP-4i)	514
DPP-4i (Matched to Empagliflozin)	641

Number of Participants With Hospitalization for Heart Failure (HHF), Specific Definition Primary · 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.

Denmark

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	273
DPP-4i (Matched to SGLT-2i)	345
Empagliflozin (Matched to DPP-4i)	178
DPP-4i (Matched to Empagliflozin)	195

Finnland

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	80
DPP-4i (Matched to SGLT-2i)	190
Empagliflozin (Matched to DPP-4i)	53
DPP-4i (Matched to Empagliflozin)	128

Germany

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	33
DPP-4i (Matched to SGLT-2i)	76
Empagliflozin (Matched to DPP-4i)	18
DPP-4i (Matched to Empagliflozin)	35

Israel

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	27
DPP-4i (Matched to SGLT-2i)	28
Empagliflozin (Matched to DPP-4i)	25
DPP-4i (Matched to Empagliflozin)	27

Japan

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	105
DPP-4i (Matched to SGLT-2i)	114
Empagliflozin (Matched to DPP-4i)	59
DPP-4i (Matched to Empagliflozin)	65

South Korea

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	12
DPP-4i (Matched to SGLT-2i)	19

Norway

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	49
DPP-4i (Matched to SGLT-2i)	124
Empagliflozin (Matched to DPP-4i)	23
DPP-4i (Matched to Empagliflozin)	63

Sweden

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	106
DPP-4i (Matched to SGLT-2i)	200
Empagliflozin (Matched to DPP-4i)	59
DPP-4i (Matched to Empagliflozin)	127

Number of Participants With All-cause Mortality (ACM) Primary · 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).

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	1371
DPP-4i (Matched to SGLT-2i)	2524
Empagliflozin (Matched to DPP-4i)	572
DPP-4i (Matched to Empagliflozin)	1177

Number of Participants With Composite Outcome, Including Hospitalization for Heart Failure (HHF) and All Cause Mortality (ACM) Primary · 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).

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	2413
DPP-4i (Matched to SGLT-2i)	3749
Empagliflozin (Matched to DPP-4i)	1239
DPP-4i (Matched to Empagliflozin)	2063

Number of Participants With Composite Outcome, Including Myocardial Infraction (MI), Stroke and All Cause Mortality (ACM) Primary · 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).

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	2548
DPP-4i (Matched to SGLT-2i)	3758
Empagliflozin (Matched to DPP-4i)	1236
DPP-4i (Matched to Empagliflozin)	1950

Number of Participants With Myocardial Infarction (MI) Primary · 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).

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	701
DPP-4i (Matched to SGLT-2i)	863
Empagliflozin (Matched to DPP-4i)	364
DPP-4i (Matched to Empagliflozin)	414

Number of Participants With Stroke Primary · 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.

Denmark

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	183
DPP-4i (Matched to SGLT-2i)	230
Empagliflozin (Matched to DPP-4i)	110
DPP-4i (Matched to Empagliflozin)	112

Finland

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	38
DPP-4i (Matched to SGLT-2i)	54
Empagliflozin (Matched to DPP-4i)	24
DPP-4i (Matched to Empagliflozin)	40

Germany

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	6
DPP-4i (Matched to SGLT-2i)	24

Israel

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	20
DPP-4i (Matched to SGLT-2i)	21
Empagliflozin (Matched to DPP-4i)	15
DPP-4i (Matched to Empagliflozin)	17

Japan

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	26
DPP-4i (Matched to SGLT-2i)	50
Empagliflozin (Matched to DPP-4i)	12
DPP-4i (Matched to Empagliflozin)	13

South Korea

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	107
DPP-4i (Matched to SGLT-2i)	187
Empagliflozin (Matched to DPP-4i)	43
DPP-4i (Matched to Empagliflozin)	68

Norway

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	72
DPP-4i (Matched to SGLT-2i)	87
Empagliflozin (Matched to DPP-4i)	28
DPP-4i (Matched to Empagliflozin)	36

Spain

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	49
DPP-4i (Matched to SGLT-2i)	53
Empagliflozin (Matched to DPP-4i)	15
DPP-4i (Matched to Empagliflozin)	27

Number of Participants With Cardiovascular Mortality (CM) Secondary · 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).

Finland

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	67
DPP-4i (Matched to SGLT-2i)	161
Empagliflozin (Matched to DPP-4i)	35
DPP-4i (Matched to Empagliflozin)	107

Norway

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	44
DPP-4i (Matched to SGLT-2i)	73
Empagliflozin (Matched to DPP-4i)	17
DPP-4i (Matched to Empagliflozin)	32

Sweden

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	56
DPP-4i (Matched to SGLT-2i)	109
Empagliflozin (Matched to DPP-4i)	24
DPP-4i (Matched to Empagliflozin)	80

Taiwan

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	53
DPP-4i (Matched to SGLT-2i)	76
Empagliflozin (Matched to DPP-4i)	28
DPP-4i (Matched to Empagliflozin)	29

Number of Participants With Composite Outcome Including Hospitalization for Heart Failure (HHF) and Cardiovascular (CV) Mortality Secondary · 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.

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	397
DPP-4i (Matched to SGLT-2i)	806
Empagliflozin (Matched to DPP-4i)	205
DPP-4i (Matched to Empagliflozin)	505

Number of Participants With 3-point Major Adverse Cardiovascular (CV) Events (MACE), Defined as a Composite Outcome Including Myocardial Infarction (MI), Stroke and Cardiovascular (CV) Mortality Secondary · 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 3-point major adverse cardiovascular (CV) events (MACE), defined as a composite outcome including myocardial infarction (MI), stroke and cardiovascular (CV) mortality.

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	843
DPP-4i (Matched to SGLT-2i)	1009
Empagliflozin (Matched to DPP-4i)	393
DPP-4i (Matched to Empagliflozin)	516

Number of Participants With Coronary Revascularization Procedure Secondary · 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 coronary revascularization procedure.

Denmark

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	173
DPP-4i (Matched to SGLT-2i)	184
Empagliflozin (Matched to DPP-4i)	117
DPP-4i (Matched to Empagliflozin)	109

Finland

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	26
DPP-4i (Matched to SGLT-2i)	19
Empagliflozin (Matched to DPP-4i)	12
DPP-4i (Matched to Empagliflozin)	15

Germany

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	9
DPP-4i (Matched to SGLT-2i)	20

Israel

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	124
DPP-4i (Matched to SGLT-2i)	103
Empagliflozin (Matched to DPP-4i)	111
DPP-4i (Matched to Empagliflozin)	89

Japan

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	268
DPP-4i (Matched to SGLT-2i)	383
Empagliflozin (Matched to DPP-4i)	158
DPP-4i (Matched to Empagliflozin)	206

South Korea

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	66
DPP-4i (Matched to SGLT-2i)	97
Empagliflozin (Matched to DPP-4i)	23
DPP-4i (Matched to Empagliflozin)	33

Norway

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	58
DPP-4i (Matched to SGLT-2i)	64
Empagliflozin (Matched to DPP-4i)	10
DPP-4i (Matched to Empagliflozin)	11

Spain

Group	Value	95% CI
SGLT-2i (Incl. Empa) (Matched to DPP-4i)	0
DPP-4i (Matched to SGLT-2i)	7

Sponsor's own description

Non-interventional, multi-country cohort study using existing data and including adults (≥18 years) with a diagnosis of Type 2 diabetes mellitus.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Cardiovascular and renal effectiveness of empagliflozin in routine care in East Asia: Results from the EMPRISE East Asia study.
Seino Y, Kim DJ, Yabe D, Tan EC, et al · · 2021 · cited 29× · PMID 33532619 · DOI 10.1002/edm2.183
Healthcare resource utilization in patients treated with empagliflozin in East Asia.
Sheu WH, Seino Y, Tan EC, Yabe D, et al · · 2022 · cited 11× · PMID 34859609 · DOI 10.1111/jdi.13728
57<sup>th</sup> EASD Annual Meeting of the European Association for the Study of Diabetes.
· 2021 · cited 11× · PMID 34468792 · DOI 10.1007/s00125-021-05519-y
Empagliflozin reduces cardiorenal events, healthcare resource use and mortality in Sweden compared to dipeptidyl peptidase-4 inhibitors: Real world evidence from the Nordic EMPRISE study.
Nyström T, Toresson Grip E, Gunnarsson J, Casajust P, et al · · 2023 · cited 3× · PMID 36097728 · DOI 10.1111/dom.14870

Verify or expand the search:

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Other Boehringer Ingelheim trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03817463 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 23 September 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03817463.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03817463

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Diabetes Mellitus, Type 2

Other Boehringer Ingelheim trials

Verify against primary sources