Last reviewed · How we verify
NCT03282136
SGLT2i and Incretin and CRTd.
Phase 4 trial testing Incretin Effect in Type 2 Diabetes Mellitus in 500 participants. Completed in 1 September 2024.
1 September 2024
Quick facts
| Lead sponsor | University of Campania Luigi Vanvitelli |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 500 |
| Start date | 1 September 2017 |
| Primary completion | 1 September 2024 |
| Estimated completion | 1 September 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Incretin Effect — full drug profile →
- Cardiac Resynchronization therapy defibrillator device
- SGLT-2 inhibitor — full drug profile →
Conditions studied
- Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →
- Heart Failure — all drugs for Heart Failure →
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):
-
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 -
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:
- PubMed search for NCT03282136
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Type 2 Diabetes Mellitus
Currently open trials in the same condition.
- NCT07351058 — A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes · Phase 3 · recruiting
- NCT07373938 — Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus · recruiting
- NCT07433062 — A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With · Phase 1 · recruiting
- NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes · NA · active not recruiting
- NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic · recruiting
Other University of Campania Luigi Vanvitelli trials
Trials by the same sponsor.
- NCT07590349 — Personalized Robotic Telerehabilitation for Upper Limb Functional Recovery After Stroke in a Home-Based Setting · NA · not yet recruiting
- NCT06718452 — Tinnitus and Treatment With umPEA-LUT · NA · not yet recruiting
- NCT07124676 — Prospective Study Comparing Two Classification Systems for Second-degree Vaginal Tears During Spontaneous Childbirth to · not yet recruiting
- NCT07425912 — Real-World Evaluation of TouchCare Nano in Pediatric Type 1 Diabetes · active not recruiting
- NCT06991816 — The Brain&Senses Study · not yet recruiting
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 NCT03282136 (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: 25 June 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/NCT03282136.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing