Division of Endocrinology and Metabolism, Department of Internal Medicine, Catholic Kwandong University College of Medicine, International St. Mary's Hospital, Incheon, Republic of Korea.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.
Diabetes Obes Metab. 2021 Feb;23(2):609-618. doi: 10.1111/dom.14259. Epub 2020 Dec 13.
To evaluate the effectiveness and safety of adding either a sodium-glucose co-transporter-2 inhibitor (SGLT2i) or thiazolidinedione (TZD) in patients with type 2 diabetes (T2D) inadequately controlled with triple therapy.
In this prospective, open-label, multicentre, 24-week clinical trial, we randomly assigned 119 patients with T2D who failed to achieve glycaemic control (7% < HbA1c ≤ 10%) with conventional triple oral antidiabetic agents (OADs; metformin, sulphonylurea and dipeptidyl peptide-4 [DPP-4] inhibitor) into two groups who received either an SGLT2i or TZD. The primary endpoint was mean change in HbA1c level between the two groups at 24 weeks.
In total, 119 patients were enrolled in the SGLT2i (n = 60) and TZD (n = 59) groups. Mean age of the study subjects was 61.86 years, and the mean duration of T2D was 13.89 years. After 24 weeks, both groups showed significant reductions in HbA1c (from 7.94% ± 0.74% to 6.97% ± 0.84% in the SGLT2i group and from 8.00% ± 0.78% to 7.18% ± 0.98% in the TZD group), without a significant between-group difference (P = .235). A significant body mass index (BMI) reduction was noted in the SGLT2i group, whereas an increase in BMI was noted in the TZD group (-0.79 ± 1.37 vs. 0.92 ± 0.86 kg/m , P < .001). Other safety profiles were favourable in both groups.
The current study shows that an SGLT2i or TZD could be a valid option as a fourth OAD for treatment of patients with T2D inadequately controlled with a triple combination of OADs.
评估在接受三重口服降糖药物（OAD；二甲双胍、磺脲类和二肽基肽酶-4 [DPP-4] 抑制剂）治疗但血糖控制不佳（7%<HbA1c≤10%）的 2 型糖尿病（T2D）患者中，加用钠-葡萄糖共转运蛋白 2 抑制剂（SGLT2i）或噻唑烷二酮（TZD）的疗效和安全性。
在这项前瞻性、开放标签、多中心、24 周的临床试验中，我们将 119 例接受常规三重 OAD 治疗但血糖控制仍不理想（7%<HbA1c≤10%）的 T2D 患者随机分为两组，分别接受 SGLT2i 或 TZD 治疗。主要终点为两组患者在 24 周时 HbA1c 水平的平均变化。
共纳入 SGLT2i 组（n=60）和 TZD 组（n=59）的 119 例患者。研究对象的平均年龄为 61.86 岁，T2D 的平均病程为 13.89 年。24 周后，两组患者的 HbA1c 均显著降低（SGLT2i 组从 7.94%±0.74%降至 6.97%±0.84%，TZD 组从 8.00%±0.78%降至 7.18%±0.98%），但两组间无显著差异（P=0.235）。SGLT2i 组的体重指数（BMI）显著降低，而 TZD 组的 BMI 则升高（-0.79±1.37 与 0.92±0.86 kg/m2，P<0.001）。两组的其他安全性指标均良好。
本研究表明，SGLT2i 或 TZD 可作为 OAD 的第四种选择，用于治疗 OAD 三联疗法控制不佳的 T2D 患者。
