PDF(Pubmed)
Abstract：
This study evaluated the efficacy and safety of add-on gemigliptin in patients with type 2 diabetes mellitus (T2DM) who had inadequate glycemic control with metformin and dapagliflozin.
In this randomized, placebo-controlled, parallel-group, double-blind, phase III study, 315 patients were randomized to receive either gemigliptin 50 mg (n=159) or placebo (n=156) with metformin and dapagliflozin for 24 weeks. After the 24-week treatment, patients who received the placebo were switched to gemigliptin, and all patients were treated with gemigliptin for an additional 28 weeks.
The baseline characteristics were similar between the two groups, except for body mass index. At week 24, the least squares mean difference (standard error) in hemoglobin A1c (HbA1c) changes was -0.66% (0.07) with a 95% confidence interval of -0.80% to -0.52%, demonstrating superior HbA1c reduction in the gemigliptin group. After week 24, the HbA1c level significantly decreased in the placebo group as gemigliptin was administered, whereas the efficacy of HbA1c reduction was maintained up to week 52 in the gemigliptin group. The safety profiles were similar: the incidence rates of treatment-emergent adverse events up to week 24 were 27.67% and 29.22% in the gemigliptin and placebo groups, respectively. The safety profiles after week 24 were similar to those up to week 24 in both groups, and no new safety findings, including hypoglycemia, were noted.
Add-on gemigliptin was well tolerated, providing comparable safety profiles and superior efficacy in glycemic control over placebo for long-term use in patients with T2DM who had poor glycemic control with metformin and dapagliflozin.
In this randomized, placebo-controlled, parallel-group, double-blind, phase III study, 315 patients were randomized to receive either gemigliptin 50 mg (n=159) or placebo (n=156) with metformin and dapagliflozin for 24 weeks. After the 24-week treatment, patients who received the placebo were switched to gemigliptin, and all patients were treated with gemigliptin for an additional 28 weeks.
The baseline characteristics were similar between the two groups, except for body mass index. At week 24, the least squares mean difference (standard error) in hemoglobin A1c (HbA1c) changes was -0.66% (0.07) with a 95% confidence interval of -0.80% to -0.52%, demonstrating superior HbA1c reduction in the gemigliptin group. After week 24, the HbA1c level significantly decreased in the placebo group as gemigliptin was administered, whereas the efficacy of HbA1c reduction was maintained up to week 52 in the gemigliptin group. The safety profiles were similar: the incidence rates of treatment-emergent adverse events up to week 24 were 27.67% and 29.22% in the gemigliptin and placebo groups, respectively. The safety profiles after week 24 were similar to those up to week 24 in both groups, and no new safety findings, including hypoglycemia, were noted.
Add-on gemigliptin was well tolerated, providing comparable safety profiles and superior efficacy in glycemic control over placebo for long-term use in patients with T2DM who had poor glycemic control with metformin and dapagliflozin.
摘要：
背景：本研究评估了添加吉格列汀对二甲双胍和达格列净血糖控制不足的2型糖尿病（T2DM）患者的疗效和安全性。
方法：在本随机分组中，安慰剂对照,平行组，双盲,第三阶段研究，315例患者随机接受吉格列汀50mg（n=159）或安慰剂（n=156）联合二甲双胍和达格列净治疗24周。经过24周的治疗，接受安慰剂的患者改用吉格列汀，所有患者均接受吉格列汀治疗28周.
结果：两组的基线特征相似，除了体重指数。在第24周，血红蛋白A1c（HbA1c）变化的最小二乘平均差（标准误差）为-0.66％（0.07），95％置信区间为-0.80％至-0.52％，吉格列汀组HbA1c降低效果更好。24周后，安慰剂组的HbA1c水平随着吉格列汀的给药而显著下降，而吉格列汀组HbA1c降低的疗效维持至第52周.安全性情况相似：在吉格列汀和安慰剂组中，直到第24周出现治疗不良事件的发生率分别为27.67%和29.22%，分别。两组第24周后的安全性与第24周相似，没有新的安全发现,包括低血糖,被注意到。
结论：加吉格列汀的耐受性良好，在二甲双胍和达格列净血糖控制不佳的2型糖尿病患者中,长期使用与安慰剂相比,在血糖控制方面提供了相当的安全性和更高的疗效.
方法：在本随机分组中，安慰剂对照,平行组，双盲,第三阶段研究，315例患者随机接受吉格列汀50mg（n=159）或安慰剂（n=156）联合二甲双胍和达格列净治疗24周。经过24周的治疗，接受安慰剂的患者改用吉格列汀，所有患者均接受吉格列汀治疗28周.
结果：两组的基线特征相似，除了体重指数。在第24周，血红蛋白A1c（HbA1c）变化的最小二乘平均差（标准误差）为-0.66％（0.07），95％置信区间为-0.80％至-0.52％，吉格列汀组HbA1c降低效果更好。24周后，安慰剂组的HbA1c水平随着吉格列汀的给药而显著下降，而吉格列汀组HbA1c降低的疗效维持至第52周.安全性情况相似：在吉格列汀和安慰剂组中，直到第24周出现治疗不良事件的发生率分别为27.67%和29.22%，分别。两组第24周后的安全性与第24周相似，没有新的安全发现,包括低血糖,被注意到。
结论：加吉格列汀的耐受性良好，在二甲双胍和达格列净血糖控制不佳的2型糖尿病患者中,长期使用与安慰剂相比,在血糖控制方面提供了相当的安全性和更高的疗效.
