Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.
Shenzhen Salubris Pharmaceuticals Co., Ltd, Shenzhen, China.
BMC Med. 2023 Oct 9;21(1):388. doi: 10.1186/s12916-023-03089-x.
Dipeptidyl peptidase-4 inhibitors (DPP-4i) have become firmly established in treatment algorithms and national guidelines for improving glycemic control in type 2 diabetes mellitus (T2DM).To report the findings from a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial, which was designed to assess the efficacy and safety of a novel DPP-4 inhibitor fotagliptin in treatment-naive patients with T2DM.
Patients with T2DM were randomized to receive fotagliptin (n = 230), alogliptin (n = 113) or placebo (n = 115) at a 2:1:1 ratio for 24 weeks of double-blind treatment period, followed by an open-label treatment period, making up a total of 52 weeks. The primary efficacy endpoint was to determine the superiority of fotagliptin over placebo in the change of HbA1c from baseline to Week 24. All serious or significant adverse events were recorded.
After 24 weeks, mean decreases in HbA1c from baseline were -0.70% for fotagliptin, -0.72% for alogliptin and -0.26% for placebo. Estimated mean treatment differences in HbA1c were -0.44% (95% confidence interval [CI]: -0.62% to -0.27%) for fotagliptin versus placebo, and -0.46% (95% CI: -0.67% to -0.26%) for alogliptin versus placebo, and 0.02% (95%CI: -0.16% to 0.19%; upper limit of 95%CI < margin of 0.4%) for fotagliptin versus alogliptin. So fotagliptin was non-inferior to alogliptin. Compared with subjects with placebo (15.5%), significantly more patients with fotagliptin (37.0%) and alogliptin (35.5%) achieved HbA1c < 7.0% after 24 weeks of treatment. During the whole 52 weeks of treatment, the overall incidence of hypoglycemia was low for both of the fotagliptin and alogliptin groups (1.0% each). No drug-related serious adverse events were observed in any treatment group.
In summary, the study demonstrated improvement in glycemic control and a favorable safety profile for fotagliptin in treatment-naive patients with T2DM.
ClinicalTrail.gov NCT05782192.
二肽基肽酶-4 抑制剂（DPP-4i）已在改善 2 型糖尿病（T2DM）患者血糖控制的治疗方案和国家指南中得到充分确立。本报告来自一项多中心、随机、双盲、安慰剂对照的 3 期临床试验结果，旨在评估新型 DPP-4 抑制剂福格列汀在初治 T2DM 患者中的疗效和安全性。
T2DM 患者按 2:1:1 的比例随机接受福格列汀（n=230）、阿格列汀（n=113）或安慰剂（n=115）治疗，为期 24 周的双盲治疗期，随后进行为期 52 周的开放标签治疗期。主要疗效终点是确定福格列汀与安慰剂相比在 24 周时 HbA1c 变化的优越性。记录所有严重或重大不良事件。
24 周后，福格列汀组 HbA1c 自基线的平均降幅为-0.70%，阿格列汀组为-0.72%，安慰剂组为-0.26%。福格列汀与安慰剂相比，HbA1c 的估计平均治疗差异为-0.44%（95%置信区间[CI]：-0.62%至-0.27%），阿格列汀与安慰剂相比为-0.46%（95%CI：-0.67%至-0.26%），福格列汀与阿格列汀相比为 0.02%（95%CI：-0.16%至 0.19%；95%CI 上限<0.4%）。因此，福格列汀与阿格列汀相比非劣效。与安慰剂组（15.5%）相比，接受福格列汀（37.0%）和阿格列汀（35.5%）治疗的患者在 24 周后 HbA1c<7.0%的比例显著更高。在整个 52 周的治疗期间，福格列汀和阿格列汀组的总体低血糖发生率均较低（各为 1.0%）。任何治疗组均未观察到与药物相关的严重不良事件。
总之，该研究表明福格列汀在初治 T2DM 患者中可改善血糖控制，并具有良好的安全性。
ClinicalTrials.gov NCT05782192。
