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

NCT06017544 | Completed

• 1 other identifier: 0124.082023
• Study Type: observational
• Target: 257
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2; Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• MACE

  The study's primary endpoint was the composite of mortality, acute heart failure, and acute coronary syndrome (SCA) requiring hospitalization.

  12 months

Study Arms (3)

T2DM patients with GLP-1 RA

T2DM patients hospitalized due to AMI as a primary diagnosis, both STEMI and NSTEMI, referred for PCI, and under GLP-1 RA.

Procedure: PCI

T2DM patients with SGLT2-is

T2DM patients hospitalized due to AMI as a primary diagnosis, both STEMI and NSTEMI, referred for PCI, and under SGLT2-is.

Procedure: PCI

T2DM patients with GLP-1 RA plus SGLT2-is

T2DM patients hospitalized due to AMI as a primary diagnosis, both STEMI and NSTEMI, referred for PCI, and under GLP-1 RA plus SGLT2-is.

Interventions

PCI PROCEDURE

The T2DM affected by AMI will be referred for receiving PCI.

T2DM patients with GLP-1 RA; T2DM patients with SGLT2-is

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

T2DM patients, treated with GLP-1 RA or SGLT-2i, hospitalized due to AMI (STEMI and NSTEMI), and referred for PCI. The patients will be stratified according to their glycemic control at the time of hospitalization: T2DM patients with HbA1c \<7% will be considered in good glycemic control. T2DM patients in good glycemic control will be further stratified according to GLP-1 RA or SGLT-2i treatment for at least 3 months before index hospitalization. The combination of GLP-1RA and SGLT2i will be adopted in T2DM in poor glycemic control (HbA1c \>7%). After discharge from the hospital, all T2DM patients will be managed and followed quarterly for two years after PCI as outpatients to maintain HbA1c level at \<7%, blood glucose level of 80-130 mg/dl, and post-prandial blood glucose level of \<180 mg/dl.

You may qualify if:

• Consecutive T2DM patients, treated with GLP-1 RA or SGLT-2i, with AMI;
• both STEMI and NSTEMI patients referred for PCI;

You may not qualify if:

• heart failure and valvular defects;
• inflammatory chronic diseases;
• neoplastic diseases.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Celestino Sardu

Naples, Naples, 80138, Italy

Location

Related Publications (1)

• Marfella R, Prattichizzo F, Sardu C, Rambaldi PF, Fumagalli C, Marfella LV, La Grotta R, Frige C, Pellegrini V, D'Andrea D, Cesaro A, Calabro P, Pizzi C, Antonicelli R, Ceriello A, Mauro C, Paolisso G. 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. Cardiovasc Diabetol. 2024 Jan 6;23(1):10. doi: 10.1186/s12933-023-02118-6.

  PMID: 38184582 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Myocardial Infarction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 30, 2023
• Study Start: January 1, 2017
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

IT (1)