title: 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.
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.
authors.affiliation: The General Hospital of the People's Liberation Army, Beijing, China.
authors.forename: Changyu
authors.initials: C
authors.lastname: Pan
authors.affiliation: Shengjing Hospital of China Medical University, Shenyang, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Han
authors.affiliation: The First Affiliated Hospital of the Fourth Military Medical University, Xi'an, China.
authors.forename: Qiuhe
authors.initials: Q
authors.lastname: Ji
authors.affiliation: First Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, China.
authors.forename: Chengjiang
authors.initials: C
authors.lastname: Li
authors.affiliation: The General Hospital of the People's Liberation Army, Beijing, China.
authors.forename: Juming
authors.initials: J
authors.lastname: Lu
authors.affiliation: Beijing Tongren Hospital, Beijing, China.
authors.forename: Jinkui
authors.initials: J
authors.lastname: Yang
authors.affiliation: Peking Union Medical College Hospital, Beijing, China.
authors.forename: Wenhui
authors.initials: W
authors.lastname: Li
authors.affiliation: Affiliated Jingzhou Hospital Tongji Medical School, Wuhan, China.
authors.forename: Jiaoe
authors.initials: J
authors.lastname: Zeng
authors.affiliation: Taipei Medical University Shuang Ho Hospital, Taipei, Taiwan.
authors.forename: An-Tsz
authors.initials: AT
authors.lastname: Hsieh
authors.affiliation: The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, SAR, China.
authors.forename: Juliana
authors.initials: J
authors.lastname: Chan
mesh_terms: D000328:Adult; D000368:Aged; D044466:Asian People; D001786:Blood Glucose / Q000378:metabolism; D002681:China; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000208:ethnology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005215:Fasting / Q000097:blood; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006723:Hong Kong; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D000077205:Pioglitazone; D010880:Piperidines / Q000627:therapeutic use*; D013624:Taiwan; D045162:Thiazolidinediones / Q000627:therapeutic use; D016896:Treatment Outcome; D014498:Uracil / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D000077205:Pioglitazone; D010880:Piperidines; D045162:Thiazolidinediones; D014498:Uracil; C520853:alogliptin
keywords: 2型糖尿病; Asian; HbA1c; alogliptin; type 2 diabetes mellitus; 亚洲; 阿格列汀