title: Efficacy and safety of saxagliptin compared with acarbose in Chinese patients with type 2 diabetes mellitus uncontrolled on metformin monotherapy: Results of a Phase IV open-label randomized controlled study (the SMART study).
abstract: To investigate the efficacy, safety and tolerability of saxagliptin compared with acarbose in Chinese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy.
  
  
  
  SMART was a 24-week, multicentre, randomized, parallel-group, open-label Phase IV study conducted at 35 sites in China (September 24, 2014 to September 29, 2015). The primary outcome was absolute change from baseline in HbA1c at Week 24. Secondary outcomes assessed at Week 24 included the proportion of patients achieving HbA1c < 7.0%, the proportion of patients with gastrointestinal adverse events (GI AEs), and the proportion of patients achieving HbA1c < 7.0% without GI AEs. Safety and tolerability were also assessed in all patients who received ≥1 dose of study medication.
  
  
  
  Four-hundred and eighty-eight patients were randomized (1:1) to saxagliptin or acarbose via a central randomization system (interactive voice/web response system); 241 and 244 patients received saxagliptin and acarbose, respectively, and 238 and 243 of these had ≥1 pre- and ≥1 post-baseline efficacy values recorded. Saxagliptin was non-inferior to acarbose for glycaemic control [Week 24 HbA1c change: -0.82% and -0.78%, respectively; difference (95% confidence interval): -0.04 (-0.22, 0.13)%], with similar proportions of patients in both treatment groups achieving HbA1c < 7.0%. However, fewer GI AEs were reported with saxagliptin compared with acarbose, and a greater number of patients who received saxagliptin achieved HbA1c < 7.0% without GI AEs compared with those receiving acarbose.
  
  
  
  Both therapies had similar efficacy profiles. However, saxagliptin was associated with fewer GI AEs, suggesting it might be preferential for clinical practice.
  
  
  
  NCT02243176, clinicaltrials.gov.
authors.affiliation: Department of Endocrinology, Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.
authors.forename: Jin
authors.initials: J
authors.lastname: Du
authors.affiliation: Department of Endocrinology, the People's Hospital of Liaoning Province, Shenyang, People's Republic of China.
authors.forename: Li
authors.initials: L
authors.lastname: Liang
authors.affiliation: Department of Endocrinology, Tangshan Gongren Hospital, Tangshan, People's Republic of China.
authors.forename: Hui
authors.initials: H
authors.lastname: Fang
authors.affiliation: Department of Endocrinology, Hebi Coal (Group) Co., Ltd General Hospital, Hebi, People's Republic of China.
authors.forename: Fengmei
authors.initials: F
authors.lastname: Xu
authors.affiliation: Department of Endocrinology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, People's Republic of China.
authors.forename: Wei
authors.initials: W
authors.lastname: Li
authors.affiliation: Department of Geriatrics, Wuhan 6th Hospital, Wuhan, People's Republic of China.
authors.forename: Liya
authors.initials: L
authors.lastname: Shen
authors.affiliation: Department of Endocrinology, Jinzhou Central Hospital, Jinzhou, People's Republic of China.
authors.forename: Xueying
authors.initials: X
authors.lastname: Wang
authors.affiliation: Department of Endocrinology, Chinese People's Armed Police Force General Hospital, Beijing, People's Republic of China.
authors.forename: Chun
authors.initials: C
authors.lastname: Xu
authors.affiliation: Department of Endocrinology, Cangzhou People's Hospital, Cangzhou, People's Republic of China.
authors.forename: Fang
authors.initials: F
authors.lastname: Bian
authors.affiliation: Department of Endocrinology, Chinese People's Liberation Army General Hospital, Beijing, People's Republic of China.
authors.forename: Yiming
authors.identifier: 0000-0003-4822-5076
authors.initials: Y
authors.lastname: Mu
mesh_terms: D020909:Acarbose / Q000627:therapeutic use*; D000218:Adamantane / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D044466:Asian People; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D002681:China; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000208:ethnology; D004151:Dipeptides / Q000627:therapeutic use*; D004351:Drug Resistance / Q000187:drug effects*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D004151:Dipeptides; D008687:Metformin; C502994:saxagliptin; D000218:Adamantane; D020909:Acarbose
keywords: DPP-4 inhibitor; HbA1c; alpha-glucosidase inhibitor; type 2 diabetes