title: Acarbose compared with metformin as initial therapy in patients with newly diagnosed type 2 diabetes: an open-label, non-inferiority randomised trial.
abstract: BACKGROUND
  Metformin is the only first-line oral hypoglycaemic drug for type 2 diabetes recommended by international guidelines with proven efficacy, safety, and cost-effectiveness. However, little information exists about its use in Asian populations. We aimed to ascertain the effectiveness of the α-glucosidase inhibitor acarbose, extensively adopted in China, compared with metformin as the alternative initial therapy for newly diagnosed type 2 diabetes.
  
  
  METHODS
  In this 48-week, randomised, open-label, non-inferiority trial, patients who were newly diagnosed with type 2 diabetes, with a mean HbA1c of 7·5%, were enrolled from 11 sites in China. After a 4-week lifestyle modification run-in, patients were assigned to 24 weeks of monotherapy with metformin or acarbose as the initial treatment, followed by a 24-week therapy phase during which add-on therapy was used if prespecified glucose targets were not achieved. Primary endpoints were to establish whether acarbose was non-inferior to metformin in HbA1c reduction at week 24 and week 48 timepoints. The non-inferiority margin was 0·3%, with an expected null difference in the change from baseline to week 48 in HbA1c. Analysis was done on a modified intention-to-treat population. This study was registered with Chinese Clinical Trial Registry, number ChiCTR-TRC-08000231.
  
  
  RESULTS
  Of the 788 patients randomly assigned to treatment groups, 784 patients started the intended study drug. HbA1c reduction at week 24 was -1·17% in the acarbose group and -1·19% in the metformin group. At week 48, the HbA1c reduction was -1·11% (acarbose) and -1·12% (metformin) with difference 0·01% (95% CI -0·12 to 0·14, p=0·8999). Six (2%) patients in the acarbose group and seven (2%) patients in the metformin group had serious adverse events, and two (1%) and four (1%) had hypoglycaemic episodes.
  
  
  CONCLUSIONS
  This study provides evidence that acarbose is similar to metformin in efficacy, and is therefore a viable choice for initial therapy in Chinese patients newly diagnosed with type 2 diabetes.
  
  
  BACKGROUND
  Bayer Healthcare (China) and Double Crane Phama.
authors.affiliation: China-Japan Friendship Hospital, Beijing, China. Electronic address: ywying_1010@163.com.
authors.forename: Wenying
authors.initials: W
authors.lastname: Yang
authors.affiliation: Shanxi Province People's Hospital, Taiyuan, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Liu
authors.affiliation: The First Hospital of China Medical University, Shenyang, China.
authors.forename: Zhongyan
authors.initials: Z
authors.lastname: Shan
authors.affiliation: West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Haoming
authors.initials: H
authors.lastname: Tian
authors.affiliation: Xiangya Second Hospital of Central South University, Changsha, China.
authors.forename: Zhiguang
authors.initials: Z
authors.lastname: Zhou
authors.affiliation: Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors.forename: Qiuhe
authors.initials: Q
authors.lastname: Ji
authors.affiliation: The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
authors.forename: Jianping
authors.initials: J
authors.lastname: Weng
authors.affiliation: Shanghai Jiaotong University Affiliated Sixth People's Hospital, Shanghai, China.
authors.forename: Weiping
authors.initials: W
authors.lastname: Jia
authors.affiliation: Chinese People's Liberation Army General Hospital, Beijing, China.
authors.forename: Juming
authors.initials: J
authors.lastname: Lu
authors.affiliation: Gansu Provincial Hospital, Lanzhou, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Liu
authors.affiliation: Beijing Chao Yang Hospital, Beijing, China.
authors.forename: Yuan
authors.initials: Y
authors.lastname: Xu
authors.affiliation: China-Japan Friendship Hospital, Beijing, China.
authors.forename: Zhaojun
authors.initials: Z
authors.lastname: Yang
authors.affiliation: Peking Union Medical College Hospital, Beijing, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Chen
mesh_terms: D020909:Acarbose / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D001786:Blood Glucose; D015992:Body Mass Index; D002681:China; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D020909:Acarbose; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin