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NCT03282136

SGLT2i and Incretin and CRTd.

Completed Phase 4 Last updated 25 June 2025
What this trial tests

Phase 4 trial testing Incretin Effect in Type 2 Diabetes Mellitus in 500 participants. Completed in 1 September 2024.

Timeline
1 September 2017
Primary endpoint
1 September 2024
1 September 2024

Quick facts

Lead sponsorUniversity of Campania Luigi Vanvitelli
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment500
Start date1 September 2017
Primary completion1 September 2024
Estimated completion1 September 2024
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

University of Campania Luigi Vanvitelli

Who can join

Adults 18 to 70, any sex, with Type 2 Diabetes Mellitus or Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Incretin therapy and sodium-glucose- transporter2 inhibitors (SGLT2i) are a treatment for type 2 diabetes (T2DM) affected by heart failure (HF) and treated with cardiac resynchromization therapy (CRT). In this study the investigators will recruit T2DM patients affected by HF with depressed ejection fraction and treated by CRT. These patients will randomly be treated by incretin v/s SGLT2i vs combined therapy with incretin+SGLT2i (and added to conventional hypoglicemic drugs). In these patients investigators will report at follow up CRT-d responders rate, mortality, and hospital admission for HF worsening. Combined therapy with incretin and SGLT2i may reduce hospital admissions for HF in T2DM v/s incretin and/or SGLT2i therapy (added to conventional hypoglicemic drugs).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Cardiac resynchronization therapy with a defibrillator (CRTd) in failing heart patients with type 2 diabetes mellitus and treated by glucagon-like peptide 1 receptor agonists (GLP-1 RA) therapy vs. conventional hypoglycemic drugs: arrhythmic burden, hospitalizations for heart fai
    Sardu C, Paolisso P, Sacra C, Santamaria M, et al · · 2018 · cited 52× · PMID 30348145 · DOI 10.1186/s12933-018-0778-9
  2. Effects of Vericiguat on the Mitochondrial Function and Clinical Outcomes in CRT Nonresponders Patients.
    Sardu C, D'Onofrio N, Fumagalli C, Balestrieri ML, et al · · 2026 · PMID 41936180 · DOI 10.1016/j.jacadv.2026.102708

Verify or expand the search:

Other recruiting trials for Type 2 Diabetes Mellitus

Currently open trials in the same condition.

Other University of Campania Luigi Vanvitelli trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT03282136.

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