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NCT06017544
GLP-1RAs) and SGLT2is Combination Therapy and MACEs in Patients with Type 2 Diabetes.
trial testing PCI in Diabetes Mellitus, Type 2 in 257 participants. Completed in 1 December 2024.
1 June 2024
Quick facts
| Lead sponsor | University of Campania Luigi Vanvitelli |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 257 |
| Start date | 1 January 2017 |
| Primary completion | 1 June 2024 |
| Estimated completion | 1 December 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- PCI
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
- Myocardial Infarction — all drugs for Myocardial Infarction →
Sponsor
University of Campania Luigi Vanvitelli
Who can join
Adults 18 to 75, any sex, with Diabetes Mellitus, Type 2 or Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Management of type 2 diabetes mellitus (T2DM) has evolved from a glucocentric to a cardiometabolic approach. Both glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 inhibitors (SGLT2is) reduce cardiovascular and kidney outcomes in T2DM patients with a low hypoglycemia risk. The T2DM di per se still carries a higher risk of mortality and major cardiovascular complications, doubling the case fatality rate. Tacking that GLP-1RAs and SGLT2is have different mechanisms of action, resulting in complementary pharmacokinetics and pharmacodynamics, the combination use may present clinical efficacy and safety in T2DM patients with AMI. However, there is limited clinical evidence that supports the combined use of these drugs, and there are currently no studies investigating the effects of combination treatment in T2DM patients with acute cardiovascular events, on MACE as well as on myocardial post-infarction rescue. Therefore, authors will conduct an observational prospective study to evaluate the effects GLP-1RAs and SGLT2is combination therapy on MACE such as mortality, acute coronary syndrome and heart failure, and myocardial salvage index (MSI) after acute myocardial infarction (AMI) in T2DM patients.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
GLP-1 receptor agonists-SGLT-2 inhibitors combination therapy and cardiovascular events after acute myocardial infarction: an observational study in patients with type 2 diabetes.
Marfella R, Prattichizzo F, Sardu C, Rambaldi PF, et al · · 2024 · cited 48× · PMID 38184582 · DOI 10.1186/s12933-023-02118-6
Verify or expand the search:
- PubMed search for NCT06017544
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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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)
- Trial protocol + status: ClinicalTrials.gov NCT06017544 (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 University of Campania Luigi Vanvitelli
- Last refreshed: 20 January 2025
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/NCT06017544.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing