title: Efficacy and safety of saxagliptin added to metformin in Asian people with type 2 diabetes mellitus: a randomized controlled trial.
abstract: OBJECTIVE
  To assess efficacy and safety of saxagliptin added to metformin versus placebo plus metformin in Asian patients with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on metformin alone.
  
  
  METHODS
  Adults (HbA(1c) 7.0-10.0%, on stable metformin ≥ 1500 mg/day) were randomized 1:1 to saxagliptin 5mg daily plus metformin (n = 283) or placebo plus metformin (n = 287). The primary end point was HbA(1c) change from baseline to Week 24.
  
  
  RESULTS
  Saxagliptin plus metformin provided significant adjusted mean decreases versus placebo plus metformin (p ≤ 0.0052) in HbA(1c) (-0.78% versus -0.37%), fasting plasma glucose (-1.14 mmol/L versus -0.58 mmol/L), and postprandial glucose area under the curve from 0 to 180 min (-315 mmol min/L versus -160 mmol min/L). Significantly more saxagliptin-treated patients achieved a therapeutic glycemic response (HbA(1c)<7.0%) (46.5% versus 30.5%; p = 0.0001). The proportion of patients experiencing adverse events (excluding hypoglycemia) was similar for saxagliptin plus metformin (42.8%) versus placebo plus metformin (40.8%). Hypoglycemic events were reported in 1.4% of patients in each group.
  
  
  CONCLUSIONS
  Saxagliptin added to metformin significantly improved glycemic control and was well tolerated in Asian patients with T2DM who had inadequate glycemic control with metformin and diet and lifestyle modification.
authors.affiliation: Department of Endocrinology, China-Japan Friendship Hospital, Yinhua No 2 East Road, Hepingli, Chao Yang District, Beijing 100029, China. ywy_1010@yahoo.com.cn
authors.forename: Wenying
authors.initials: W
authors.lastname: Yang
authors.forename: Chang Yu
authors.initials: CY
authors.lastname: Pan
authors.forename: Conrad
authors.initials: C
authors.lastname: Tou
authors.forename: June
authors.initials: J
authors.lastname: Zhao
authors.forename: Ingrid
authors.initials: I
authors.lastname: Gause-Nilsson
mesh_terms: D000218:Adamantane / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D001208:Asia / Q000453:epidemiology; D044466:Asian People / Q000706:statistics & numerical data; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D004151:Dipeptides / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000218:Adamantane; D015415:Biomarkers; D001786:Blood Glucose; D004151:Dipeptides; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; C517652:hemoglobin A1c protein, human; C502994:saxagliptin