# Patterns and Clinical Outcomes of Sitagliptin/Metformin Extended-Release in Internal Medicine: A Real-World Multicenter Italian Study

**Authors:** Mariarosaria De Luca, Michele Arcopinto, Giosiana Bosco, Sebastiano Cicco, Francesco Di Giacomo Barbagallo, Chiara Giacinti, Marialuisa Sveva Marozzi, Maristella Salvatora Masala, Miriam Pinna, Giacomo Pucci, Andrea Salzano, Roberto Scicali, Alberto Maria Marra, Antonio Cittadini

PMC · DOI: 10.3390/jcm15030927 · Journal of Clinical Medicine · 2026-01-23

## TL;DR

This study shows that combining sitagliptin and extended-release metformin improves blood sugar control in older, complex diabetes patients without causing side effects.

## Contribution

The study provides real-world evidence of SITA/MET ER's effectiveness and safety in multimorbid T2DM patients in internal medicine settings.

## Key findings

- HbA1c and fasting glucose levels significantly decreased after 3–4 months of SITA/MET ER treatment.
- Treatment adherence was excellent, with no adverse events reported.
- Use of sulfonylureas decreased significantly, while insulin and SGLT2 inhibitor use remained stable.

## Abstract

Background: In internal medicine, the management of type 2 diabetes mellitus (T2DM) is challenged by multimorbidity and polypharmacy. The fixed-dose combination of sitagliptin and extended-release metformin (SITA/MET ER) is a valuable option for frail and comorbid patients. Methods: This multicenter, retrospective, observational study involved five Italian Internal Medicine units. Consecutive patients with T2DM who initiated SITA/MET ER were included. Demographic, clinical, and laboratory data were collected at baseline (T0) and at follow-up (T1, 3–4 months). The primary endpoint was change in HbA1c; secondary endpoints included fasting plasma glucose (FPG), treatment adherence, adverse events, and modifications in concomitant antidiabetic therapies. Results: A total of 292 patients (mean age 70.8 ± 10.6 years; 43% female) were analyzed. At baseline, mean HbA1c was 7.4 ± 1.0% and FPG 150.2 ± 42.5 mg/dL, with significant reductions observed at follow-up (HbA1c 7.0 ± 0.8%, FPG 136.8 ± 29.6 mg/dL; both p < 0.05). SITA/MET ER was predominantly prescribed to patients with a complex clinical profile, as reflected by the high prevalence of microvascular (37%) and macrovascular (42%) complications. The use of sulfonylureas decreased from 11% to 3% (p < 0.001), while SGLT2 inhibitor and insulin use remained stable. Treatment adherence to SITA/MET ER was excellent, with full compliance reported and no adverse events recorded. Conclusions: In this real-world internal medicine study, SITA/MET ER improved glycemic control and was well tolerated among patients with complex clinical profiles. These findings support the role of SITA/MET ER as a flexible and practical therapeutic choice in this setting.

## Linked entities

- **Chemicals:** sitagliptin (PubChem CID 4369359), metformin (PubChem CID 4091), insulin (PubChem CID 70678557)
- **Diseases:** type 2 diabetes mellitus (MONDO:0005148)

## Full-text entities

- **Genes:** INS (insulin) [NCBI Gene 3630] {aka IDDM, IDDM1, IDDM2, ILPR, IRDN, MODY10}, SLC5A2 (solute carrier family 5 member 2) [NCBI Gene 6524] {aka SGLT2}, SLTM (SAFB like transcription modulator) [NCBI Gene 79811] {aka Met}, EREG (epiregulin) [NCBI Gene 2069] {aka EPR, ER, Ep}
- **Diseases:** T2DM (MESH:D003924)
- **Chemicals:** sulfonylureas (MESH:D013453), glucose (MESH:D005947), Metformin (MESH:D008687), FPG (-), Sitagliptin (MESH:D000068900)
- **Species:** Homo sapiens (human, species) [taxon 9606]

## Full text

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## Figures

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## References

20 references — full list in the complete paper: https://tomesphere.com/paper/PMC12898078/full.md

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Source: https://tomesphere.com/paper/PMC12898078