title: Efficacy and safety of fixed-dose combination therapy, alogliptin plus metformin, in Asian patients with type 2 diabetes: A phase 3 trial.
abstract: This study evaluated the efficacy and safety of 26 weeks of twice-daily (BID) alogliptin + metformin fixed-dose combination (FDC) therapy in Asian patients with type 2 diabetes. Patients aged 18 to 75 years with hemoglobin A1c (HbA1c) of 7.5% to 10.0% after ≥2 months of diet and exercise and a 4-week placebo run-in were enrolled. Eligible patients were randomized (1:1:1:1) to placebo, alogliptin 12.5 mg BID, metformin 500 mg BID or alogliptin 12.5 mg plus metformin 500 mg FDC BID. The primary endpoint was change in HbA1c from baseline to end of treatment (Week 26). In total, 647 patients were randomized. The least-squares mean change in HbA1c from baseline to Week 26 was -0.19% with placebo, -0.86% with alogliptin, -1.04% with metformin and -1.53% with alogliptin + metformin FDC. Alogliptin + metformin FDC was significantly more effective ( P  < .0001) in lowering HbA1c than either alogliptin or metformin alone. The safety profile of alogliptin + metformin FDC was similar to that of the individual components alogliptin and metformin. The study demonstrated that treatment with alogliptin + metformin FDC BID resulted in better glycaemic control than either monotherapy and was well tolerated in Asian patients with type 2 diabetes.
authors.affiliation: Department of Endocrinology, Peking University People's Hospital, Beijing, China.
authors.forename: Linong
authors.identifier: 0000-0003-1305-1598
authors.initials: L
authors.lastname: Ji
authors.affiliation: Department of Endocrinology, Shengjing Hospital of China Medical University, Shenyang, China.
authors.forename: Ling
authors.initials: L
authors.lastname: Li
authors.affiliation: Department of Endocrinology, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.
authors.forename: Jian
authors.initials: J
authors.lastname: Kuang
authors.affiliation: Department of Endocrinology, Jiangsu Province Hospital, Nanjing, China.
authors.forename: Tao
authors.initials: T
authors.lastname: Yang
authors.affiliation: Department of Internal Medicine, Ilsan Paik Hospital, Inje University, Goyang, Korea.
authors.forename: Dong-Jun
authors.initials: DJ
authors.lastname: Kim
authors.affiliation: Department of Family Medicine, Universiti Sains Malaysia, Kubang Kerian, Malaysia.
authors.forename: Azidah A
authors.initials: AA
authors.lastname: Kadir
authors.affiliation: Department of Endocrinology and Metabolism, Chung Shang Medical University Hospital, Taichung City, Taiwan, China.
authors.forename: Chien-Ning
authors.initials: CN
authors.lastname: Huang
authors.affiliation: Takeda Development Centre Europe, Ltd, London, United Kingdom.
authors.forename: Douglas
authors.initials: D
authors.lastname: Lee
mesh_terms: D002681:China / Q000453:epidemiology; D003131:Combined Modality Therapy / Q000009:adverse effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000208:ethnology / Q000628:therapy; D003927:Diet, Diabetic / Q000208:ethnology; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000009:adverse effects; D015444:Exercise; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000453:epidemiology / Q000517:prevention & control*; D007003:Hypoglycemia / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018928:Immunity, Mucosal / Q000187:drug effects; D015994:Incidence; D008296:Malaysia / Q000453:epidemiology; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010880:Piperidines / Q000009:adverse effects / Q000627:therapeutic use*; D056910:Republic of Korea / Q000453:epidemiology; D012141:Respiratory Tract Infections / Q000453:epidemiology / Q000276:immunology; D013624:Taiwan / Q000453:epidemiology; D014498:Uracil / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D010880:Piperidines; D014498:Uracil; C517652:hemoglobin A1c protein, human; C520853:alogliptin
keywords: 
  DPP-IV inhibitor; alogliptin; glycaemic control; metformin; type 2 diabetes