Efficacy and safety of alogliptin in patients with type 2 diabetes mellitus: A multicentre randomized double‐blind placebo‐controlled Phase 3 study in mainland China, Taiwan, and Hong Kong: 阿格列汀治疗2型糖尿病患者的疗效和安全性:在中国大陆, 台湾, 香港进行的一项多中心随机双盲安慰剂对照的3期研究. (1st August 2016)

• Record Type: Journal Article
• Authors: Pan, Changyu; Han, Ping; Ji, Qiuhe; Li, Chengjiang; Lu, Juming; Yang, Jinkui; Li, Wenhui; Zeng, Jiaoe; Hsieh, An‐Tsz; Chan, Juliana
• Is Part Of: Journal of diabetes. Volume 9:Number 4(2017)
• Page Start: 386
• Page End: 395
• Publication Date: 2016-08-01
• Subjects: alogliptin -- Asian -- HbA1c -- type 2 diabetes mellitus; 阿格列汀 -- 亚洲 -- HbA1c -- 2型糖尿病; Diabetes -- Periodicals; 618.3646005
• DOI: 10.1111/1753-0407.12425
• Languages: English
• ISSNs: 1753-0393

Abstract

Abstract: Background: This study determined the efficacy and safety of once‐daily oral alogliptin in patients from mainland China, Taiwan, and Hong Kong with type 2 diabetes mellitus. Methods: In this Phase 3 multicenter double‐blind placebo‐controlled 16‐week trial, 506 patients were randomized to receive once‐daily alogliptin 25 mg or placebo: 185 in the monotherapy group, 197 in the add‐on to metformin group, and 124 in the add‐on to pioglitazone group. The primary efficacy variable was the change from baseline (CFB) in HbA1c at Week 16; other efficacy measures included CFB to Week 16 in fasting plasma glucose (FPG), incidence of marked hyperglycemia (FPG ≥11.1 mmol/L), and the incidence of clinical HbA1c ≤6.5 % (48 mmol/mol) and ≤7.0 % (53 mmol/mol) at Week 16. Safety was assessed throughout the trial. Results: Alogliptin monotherapy provided a significantly greater decrease in HbA1c from baseline to Week 16 compared with placebo (−0.58 %; 95 % confidence interval [CI] –0.78 %, −0.37 %; P < 0.001). As an add‐on to metformin or pioglitazone, alogliptin also significantly decreased HbA1c compared with placebo (−0.69 % [95 % CI −0.87 %, −0.51 %; P < 0.001] and −0.52 % [95 % CI −0.75 %, −0.28 %; P < 0.001], respectively). In any treatment group versus placebo, alogliptin led to greater decreases in FPG ( P ≤ 0.004) and a higher percentage of patients who achieved an HbA1c target of ≤6.5 % and ≤7.0 % ( P ≤ 0.003). No weight gain was observed in any treatment group. A similar percentage of patients experienced drug‐related, treatment‐emergent adverse events in the alogliptin and placebo arms. Four and two patients in the alogliptin and placebo arms, respectively, experienced mild or moderate hypoglycemia. Conclusions: Alogliptin 25 mg once daily reduced HbA1c and FPG and enhanced clinical response compared with placebo when used as monotherapy or as an add‐on to metformin or pioglitazone. Therapy with alogliptin was well tolerated. Highlights: In Asian patients, alogliptin 25 mg once daily reduced HbA1c, fasting plasma glucose (FPG), and the incidence of marked hyperglycemia (FPG ≥11.1 mmol/L) and increased the incidence of clinical HbA1c ≤6.5% and ≤7.0% compared with placebo when used as monotherapy or as an add‐on to metformin or pioglitazone. Alogliptin therapy was well tolerated with no safety concerns. Least squares mean (± SE) change from baseline in HbA1c over time for alogliptin 25 mg as (a) monotherapy, (b) add‐on to metformin, and (c) add‐on to pioglitazone (with or without metformin) therapy versus placebo.