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Patients were randomized (visit 1) to receive POLYCHEM or SDC for 16 weeks, after which, if there was regression of diabetic hyperglycemia (visit 2), drug therapy was suspended. The primary endpoint was remission (HbA1c\u2009&lt;\u20096.5%; 48 mmol\/mol) assessed at least 12 weeks (visit 3) after ceasing any glucose-lowering pharmacotherapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      108 patients (80% males, age: 58\u2009\u00b1\u20099 yrs), were enrolled in the study, of whom 60 were randomized to POLYCHEM and 48 to SDC treatment. After 16 weeks, 54 (90.0%) and 37 (77.1%) patients achieved regression of diabetic hyperglycemia in the POLYCHEM and SDC arm, respectively (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.002). At visit 3, 23 (38.3%) and 21 (43.8%) patients achieved diabetes remission in the POLYCHEM and SDC arm, respectively (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.59). The difference between the upper 95% CI in POLYCHEM (50.9%) and the lower 95% CI in SDC (30.4%) of diabetes remission was 20.5%.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>A four-drug regimen with minimal to null weight-lowering effect is not superior to current SDC in achieving remission in patients with newly diagnosed type 2 diabetes. If a superiority of POLYCHEM over SDC exists, it is expected to be \u2264\u200920.5%.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s40618-026-02930-3","type":"journal-article","created":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T10:41:59Z","timestamp":1785148919000},"page":"2521-2531","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Oral polychemotherapy to induce remission in newly diagnosed type 2 diabetes: results from a randomized controlled trial"],"prefix":"10.1007","volume":"49","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8666-4849","authenticated-orcid":false,"given":"Alessandra","family":"Dei Cas","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raffaella","family":"Aldigeri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Maglietta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emanuela","family":"Balestreri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monia","family":"Garofolo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Daniele","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Penno","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maddalena","family":"Trombetta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Csermely","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monica","family":"Antonini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela","family":"Vazzana","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valentina","family":"Moretti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Flamigni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valentina","family":"Spigoni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gloria","family":"Cinquegrani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federica","family":"Fantuzzi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcello","family":"Monesi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Di Bartolo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Uberto","family":"Pagotto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caterina","family":"Caminiti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Riccardo C.","family":"Bonadonna","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,7,27]]},"reference":[{"key":"2930_CR1","unstructured":"https:\/\/diabetesatlas.org\/resources\/idf-diabetes-atlas-2025https:\/\/idf.org\/about-diabetes\/diabetes-facts-figures\/"},{"issue":"4","key":"2930_CR2","doi-asserted-by":"publisher","first-page":"101660","DOI":"10.1016\/j.diabet.2025.101660","volume":"51","author":"Q He","year":"2025","unstructured":"He Q, Wu W, Chen J et al (2025) Global Burden of type 2 diabetes in non-elderly individuals 1990 to 2021 and projections for 2050: a systematic analysis of the 2021 Global Burden of Disease. 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P.D.B has participated on speaker\u2019s bureaus for Novo Nordisk, Lilly Italia, Boehringer Ingelheim, AstraZeneca spa. Sanofi Italia, Theras Italia, Bayer Italia, Glaxo Italia, Amgen, and advisory board for Novo Nordisk, Eli Lilly, Boehringer-Ingelheim, Astra Zeneca, Sanofi Italia, Amgen Italia, Bayer Italia. R.C.B received speaker fees from Novo Nordisk, Eli Lilly, Boehringer-Ingelheim, Astra-Zeneca and advisory board fees from Novo Nordisk, Eli Lilly, Boehringer-Ingelheim, and Vertex. M.T. received speaker fees from Abbott and Theros. R.A., G.M., G.D., E.B., M.G., G.P., A.C., S.F., M.A., A.V., V.M, V.S., G.C., F.F, M.M., U.P., C.C. have nothing to declare.","order":1,"name":"Ethics","label":"<b>Conflict of Interest<\/b>","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"ClinicalTrials.gov number: NCT04271189.","order":2,"name":"Ethics","label":"Clinical trial information","group":{"name":"EthicsHeading","label":"Declarations"}}]}}