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<p>We investigated the efficacy and safety of pioglitazone compared to dapagliflozin when added to metformin plus alogliptin for patients with type 2 diabetes. The patients (n = 133) were randomized to receive pioglitazone (n = 65) or dapagliflozin (n = 68) in addition to metformin and alogliptin therapy for 26&#xa0;weeks. The primary endpoint was a change in HbA1c. The non-inferiority margin for HbA1c reduction was 0.4%. The adjusted mean change of HbA1c at week 26 was − 0.75% with pioglitazone and − 0.88% with dapagliflozin (mean difference: 0.12% [95% CI − 0.09 to 0.34]). The adjusted mean change of HOMA-IR at week 26 was − 1.55 with pioglitazone and − 1.96 with dapagliflozin (mean difference: 0.41 [95% CI − 0.01 to 0.83]). Lipid profiles were similar between the groups. The proportion of patients achieving HbA1c &lt; 6.5% was similar between groups. Pioglitazone added to metformin and alogliptin significantly improved glycemic control in patients with type 2 diabetes, and was non-inferior to dapagliflozin. This study suggests that pioglitazone could be an effective and safe option for patients with inadequate glycemic control on metformin and DPP4i.</p>

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Efficacy and safety of pioglitazone versus dapagliflozin as an add-on to metformin and alogliptin combination therapy: the EPIDOTE study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月11日

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  • Kyuho Kim,
  • Seung-Hyun Ko,
  • Jae-Seung Yun,
  • Kwan-Woo Lee,
  • Eun Sook Kim,
  • In-Kyung Jeong,
  • Jae Hyeon Kim,
  • Sang Yong Kim,
  • Kyu Chang Won,
  • Mikyung Kim,
  • Bong-Soo Cha,
  • Sungrae Kim,
  • Sung Hee Choi,
  • Eun-Jung Rhee,
  • Sin Gon Kim,
  • Bo Hyun Kim,
  • Kang Seo Park,
  • Young-Cheol Ju,
  • Tae-Won Heo,
  • Yu-Bae Ahn

摘要

We investigated the efficacy and safety of pioglitazone compared to dapagliflozin when added to metformin plus alogliptin for patients with type 2 diabetes. The patients (n = 133) were randomized to receive pioglitazone (n = 65) or dapagliflozin (n = 68) in addition to metformin and alogliptin therapy for 26 weeks. The primary endpoint was a change in HbA1c. The non-inferiority margin for HbA1c reduction was 0.4%. The adjusted mean change of HbA1c at week 26 was − 0.75% with pioglitazone and − 0.88% with dapagliflozin (mean difference: 0.12% [95% CI − 0.09 to 0.34]). The adjusted mean change of HOMA-IR at week 26 was − 1.55 with pioglitazone and − 1.96 with dapagliflozin (mean difference: 0.41 [95% CI − 0.01 to 0.83]). Lipid profiles were similar between the groups. The proportion of patients achieving HbA1c < 6.5% was similar between groups. Pioglitazone added to metformin and alogliptin significantly improved glycemic control in patients with type 2 diabetes, and was non-inferior to dapagliflozin. This study suggests that pioglitazone could be an effective and safe option for patients with inadequate glycemic control on metformin and DPP4i.