Last reviewed · How we verify
NCT03363464
Comparative Effectiveness of Empagliflozin in the US
trial testing Empagliflozin in Diabetes Mellitus, Type 2 in 230,000 participants. Participants enrolled and being followed up; not accepting new ones.
30 April 2026
Quick facts
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 230,000 |
| Start date | 16 October 2017 |
| Primary completion | 30 April 2026 |
| Estimated completion | 30 April 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Empagliflozin (empagliflozin) — full drug profile →
- DPP-4 inhibitor — full drug profile →
- GLP-1 receptor agonist — 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.
Sponsor's own description
Empagliflozin, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, was launched as a treatment for type 2 diabetes mellitus (T2DM) in the U.S. in August 2014. In contrast with several previous cardiovascular outcomes trials, which failed to demonstrate an association with a higher or a lower risk of cardiovascular outcomes associated with members of other recently marketed antidiabetic classes, the EMPA-REG OUTCOME trial has shown that patients at high cardiovascular risk randomized to empagliflozin vs. placebo, were associated with a reduced risk of hospitalization for heart failure, cardiovascular mortality, and all-cause mortality. However, these and other findings arising from an extensive clinical trial program aimed at evaluating the efficacy and safety profile for empagliflozin have yet to be demonstrated in a non-trial environment. This study aims to investigate the transferability of the effects demonstrated in dedicated randomized clinical studies to a broader population under real world conditions.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Empagliflozin and the Risk of Heart Failure Hospitalization in Routine Clinical Care.
Patorno E, Pawar A, Franklin JM, Najafzadeh M, et al · · 2019 · cited 153× · PMID 30955357 · DOI 10.1161/circulationaha.118.039177 -
Impact of Glucose-Lowering Medications on Cardiovascular and Metabolic Risk in Type 2 Diabetes.
Patti AM, Rizvi AA, Giglio RV, Stoian AP, et al · · 2020 · cited 43× · PMID 32225082 · DOI 10.3390/jcm9040912 -
Effectiveness and safety of empagliflozin in routine care patients: Results from the EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study.
Patorno E, Pawar A, Wexler DJ, Glynn RJ, et al · · 2022 · cited 41× · PMID 34729891 · DOI 10.1111/dom.14593 -
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 -
The EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study programme: Design and exposure accrual for an evaluation of empagliflozin in routine clinical care.
Patorno E, Najafzadeh M, Pawar A, Franklin JM, et al · · 2020 · cited 23× · PMID 31922030 · DOI 10.1002/edm2.103 -
Cardiorenal effectiveness of empagliflozin vs. glucagon-like peptide-1 receptor agonists: final-year results from the EMPRISE study.
Htoo PT, Tesfaye H, Schneeweiss S, Wexler DJ, et al · · 2024 · cited 19× · PMID 38331813 · DOI 10.1186/s12933-024-02150-0 -
Empagliflozin in Adults with Chronic Kidney Disease (CKD): Current Evidence and Place in Therapy.
Colbert GB, Madariaga HM, Gaddy A, Elrggal ME, et al · · 2023 · cited 3× · PMID 36756278 · DOI 10.2147/tcrm.s398163 -
Health Care Utilization and Costs Associated With Empagliflozin in Older Adults With Type 2 Diabetes.
Htoo PT, NajafZadeh M, Tesfaye H, Schneeweiss S, et al · · 2024 · cited 2× · PMID 38917305 · DOI 10.2337/dc24-0270
Verify or expand the search:
- PubMed search for NCT03363464
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Empagliflozin
Trials testing the same drug.
- NCT07060417 — Vascular Effects of SGLT2i in Non-diabetic CKD · Phase 2 · not yet recruiting
- NCT06625073 — Randomized Trial of SGLT2i in Heart Transplant Recipients · Phase 4 · recruiting
- NCT07107945 — A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease · Phase 3 · recruiting
- NCT07214818 — SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome · Phase 2, PHASE3 · active not recruiting
- NCT07180745 — Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease · Phase 4 · not yet recruiting
Other recruiting trials for Diabetes Mellitus, Type 2
Currently open trials in the same condition.
- NCT07415954 — A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 · Phase 2 · recruiting
- NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part · recruiting
- NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use · NA · recruiting
- NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
- NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · recruiting
Other Boehringer Ingelheim trials
Trials by the same sponsor.
- NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
- NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
- NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
- NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
- NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03363464 (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: 18 February 2026
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/NCT03363464.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing