Journal of endocrinological investigation · 2026
Oral polychemotherapy to induce remission in newly diagnosed type 2 diabetes: results from a randomized controlled trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеPragmatic Clinical TrialКлиническое исследование III фазыНазвание и аннотация: Перевод пока не подготовлен
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Dei Cas Alessandra, Aldigeri Raffaella, Maglietta Giuseppe, Balestreri Emanuela, Garofolo Monia, Daniele Giuseppe, Penno Giuseppe, Trombetta Maddalena, Csermely Alessandro, Antonini Monica, Vazzana Angela, Moretti Valentina, Flamigni Sara, Spigoni Valentina, Cinquegrani Gloria, Fantuzzi Federica, Monesi Marcello, Di Bartolo Paolo, Pagotto Uberto, Caminiti Caterina, Bonadonna Riccardo C
Аннотация
PURPOSE: To assess the efficacy of a four-drug regimen (POLYCHEM) vs. standard diabetes care (SDC) in inducing remission in patients with newly diagnosed type 2 diabetes.
METHODS: A multicenter, open-label, pragmatic, phase III, randomized clinical trial (NCT04271189) was conducted in 6 Italian Diabetes Outpatient Clinics. 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 < 6.5%; 48 mmol/mol) assessed at least 12 weeks (visit 3) after ceasing any glucose-lowering pharmacotherapy.
RESULTS: 108 patients (80% males, age: 58 ± 9 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 (p = 0.002). At visit 3, 23 (38.3%) and 21 (43.8%) patients achieved diabetes remission in the POLYCHEM and SDC arm, respectively (p = 0.59). 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%.
CONCLUSION: 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 ≤ 20.5%.
METHODS: A multicenter, open-label, pragmatic, phase III, randomized clinical trial (NCT04271189) was conducted in 6 Italian Diabetes Outpatient Clinics. 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 < 6.5%; 48 mmol/mol) assessed at least 12 weeks (visit 3) after ceasing any glucose-lowering pharmacotherapy.
RESULTS: 108 patients (80% males, age: 58 ± 9 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 (p = 0.002). At visit 3, 23 (38.3%) and 21 (43.8%) patients achieved diabetes remission in the POLYCHEM and SDC arm, respectively (p = 0.59). 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%.
CONCLUSION: 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 ≤ 20.5%.