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NCT06017544

GLP-1RAs) and SGLT2is Combination Therapy and MACEs in Patients with Type 2 Diabetes.

Completed Last updated 20 January 2025
What this trial tests

trial testing PCI in Diabetes Mellitus, Type 2 in 257 participants. Completed in 1 December 2024.

Timeline
1 January 2017
Primary endpoint
1 June 2024
1 December 2024

Quick facts

Lead sponsorUniversity of Campania Luigi Vanvitelli
StatusCompleted
Study typeOBSERVATIONAL
Enrollment257
Start date1 January 2017
Primary completion1 June 2024
Estimated completion1 December 2024
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

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):

  1. 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

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Other trials of PCI

Trials testing the same drug.

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Currently open trials in the same condition.

Other University of Campania Luigi Vanvitelli trials

Trials by the same sponsor.

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