Efficacy and safety of pioglitazone, empagliflozin and glimepiride as third-line agents in patients with type 2 diabetes inadequately controlled with metformin and DPP-4 inhibitors: A multicentre, phase 4 randomized controlled trial
  • Cho, Yun Kyung
  • Cho, Jae-Hyoung
  • Hong, Sang-Mo
  • Park, Jung Hwan
  • Lee, Byung-Wan
  • ... Kim, Jae Hyeon
  • 외 5명
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Aims: To assess the efficacy and safety of three triple-combination therapies in patients with type 2 diabetes (T2D) inadequately controlled on metformin and a dipeptidyl peptidase-4 (DPP-4) inhibitor. Materials and methods: This multicentre, prospective, randomised, open-label, parallel-group, phase 4 study included patients with T2D inadequately controlled on metformin (>= 1000 mg) and a DPP-4 inhibitor. Participants were randomised to receive empagliflozin 10 mg/day (n = 61), pioglitazone 15 mg/day (n = 58) or glimepiride 2 mg/day (n = 57). The primary outcome was glycated haemoglobin (HbA1c) level change after 24 weeks of treatment. Results: The mean age, HbA1c level and diabetes duration of the patients were 58.5 +/- 10.0 years, 7.8 +/- 0.7% and 8.1 +/- 5.6 years, respectively. HbA1c level decreased after treatment (-0.78 +/- 0.09, empagliflozin; -0.89 +/- 0.09, pioglitazone; and -0.93 +/- 0.12 glimepiride). No significant differences were observed in HbA1c reduction among the three triple-combination therapies. The proportions of patients with HbA1c < 7.0% were similar across the three regimens (65.6%, empagliflozin; 56.9%, pioglitazone; and 63.2%, glimepiride). Significant weight loss was observed in the empagliflozin group (-1.73 +/- 3.14 kg), whereas weight gain was observed in the pioglitazone and glimepiride groups (1.11 +/- 3.97 kg and 1.11 +/- 4.07 kg, respectively). The glimepiride group reported four hypoglycaemic episodes (6.56%), while none were reported in the other groups. Conclusions: The addition of empagliflozin, pioglitazone, or glimepiride to metformin and DPP-4 inhibitors significantly improved glycaemic control in patients with T2D. The selection of a third agent should be individualized based on the patient characteristics.

키워드

antidiabetic drugglycaemic controlphase IV studyrandomised trialtype 2 diabetesADD-ON THERAPYDOUBLE-BLINDINSULIN SENSITIVITYCLINICAL-TRIALPARALLEL-GROUP24-WEEK
제목
Efficacy and safety of pioglitazone, empagliflozin and glimepiride as third-line agents in patients with type 2 diabetes inadequately controlled with metformin and DPP-4 inhibitors: A multicentre, phase 4 randomized controlled trial
저자
Cho, Yun KyungCho, Jae-HyoungHong, Sang-MoPark, Jung HwanLee, Byung-WanYoo, Jee HeeKim, Jae HyeonChun, Sung WanHwang, You-CheolSong, Kee-HoLee, Woo Je
DOI
10.1111/dom.70030
발행일
2025-11
유형
Article; Early Access
저널명
Diabetes, Obesity and Metabolism
27
11
페이지
6375 ~ 6385