Last reviewed · How we verify
NCT04215523
Replication of the DECLARE Diabetes Trial in Healthcare Claims
trial testing Dapagliflozin in Diabetes in 49,790 participants. Completed in 18 February 2021.
18 February 2021
Quick facts
| Lead sponsor | Brigham and Women's Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 49,790 |
| Start date | 8 July 2019 |
| Primary completion | 18 February 2021 |
| Estimated completion | 18 February 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Dapagliflozin (DAPAGLIFLOZIN) — full drug profile →
- DPP-4 inhibitor — full drug profile →
Conditions studied
- Diabetes — all drugs for Diabetes →
Sponsor
Brigham and Women's Hospital
Who can join
Adults 18 to 120, any sex, with Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Emulating Randomized Clinical Trials With Nonrandomized Real-World Evidence Studies: First Results From the RCT DUPLICATE Initiative.
Franklin JM, Patorno E, Desai RJ, Glynn RJ, et al · · 2021 · cited 235× · PMID 33327727 · DOI 10.1161/circulationaha.120.051718
Verify or expand the search:
- PubMed search for NCT04215523
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07239011 — Dapagliflozin in Depression · Phase 1, PHASE2 · recruiting
- NCT06851962 — Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes. · Phase 4 · active not recruiting
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Currently open trials in the same condition.
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- NCT07417865 — ECHO Diabetes FQHC · recruiting
Other Brigham and Women's Hospital trials
Trials by the same sponsor.
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- NCT04519177 — Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability ... · NA · not yet recruiting
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- NCT06099275 — Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography · suspended
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 NCT04215523 (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 Brigham and Women's Hospital
- Last refreshed: 27 July 2023
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/NCT04215523.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing