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Purpose <p>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.</p> Methods <p>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 &lt; 6.5%; 48 mmol/mol) assessed at least 12 weeks (visit 3) after ceasing any glucose-lowering pharmacotherapy.</p> Results <p>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 (<i>p</i> = 0.002). At visit 3, 23 (38.3%) and 21 (43.8%) patients achieved diabetes remission in the POLYCHEM and SDC arm, respectively (<i>p</i> = 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%.</p> Conclusion <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 ≤ 20.5%.</p>

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Oral polychemotherapy to induce remission in newly diagnosed type 2 diabetes: results from a randomized controlled trial

  • 期刊论文

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  • 发表日期：

    2026年7月27日

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  • Alessandra Dei Cas,
  • Raffaella Aldigeri,
  • Giuseppe Maglietta,
  • Emanuela Balestreri,
  • Monia Garofolo,
  • Giuseppe Daniele,
  • Giuseppe Penno,
  • Maddalena Trombetta,
  • Alessandro Csermely,
  • Monica Antonini,
  • Angela Vazzana,
  • Valentina Moretti,
  • Sara Flamigni,
  • Valentina Spigoni,
  • Gloria Cinquegrani,
  • Federica Fantuzzi,
  • Marcello Monesi,
  • Paolo Di Bartolo,
  • Uberto Pagotto,
  • Caterina Caminiti,
  • Riccardo C. Bonadonna

摘要

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%.