title: Efficacy and tolerability of exenatide twice daily and exenatide once weekly in Asian versus White patients with type 2 diabetes mellitus: A pooled analysis.
abstract: OBJECTIVE
  The efficacy and safety of exenatide twice daily (BID) and once weekly (QW) were assessed in Asian versus White patients with type 2 diabetes mellitus (T2DM).
  
  
  METHODS
  This post-hoc pooled analysis evaluated patients receiving 10μg exenatide BID for 12-30 weeks or 2mg exenatide QW for 24-30 weeks in exenatide clinical development program trials. Race was self-identified.
  
  
  RESULTS
  A total of 4625 patients were included (exenatide BID: Asian, n=787; White, n=2223; exenatide QW: Asian, n=511; White, n=1104). At study end, glycated hemoglobin (HbA1c), fasting glucose (FG), body weight, post-prandial glucose (PPG), and PPG excursions were significantly reduced (all P<0.0001 vs baseline). For exenatide BID, HbA1c reduction was greater in Asians (P<0.0001 vs Whites), whereas HbA1c reduction did not differ by race for exenatide QW. FG reduction did not differ by race for either exenatide formulation. Weight reduction was significantly greater in Whites (P<0.0001 vs Asians), regardless of exenatide formulation. PPG reduction was greater in Asians (P<0.0001 vs Whites) for exenatide BID but did not differ by race for exenatide QW. For exenatide BID, reductions in PPG excursions for all meals were significantly greater in Asians (P<0.0001 vs Whites), whereas only post-breakfast and post-lunch excursions were significantly greater in Asians for exenatide QW (P=0.0009 and P=0.0189 vs Whites, respectively). Common adverse events included nausea, headache, and diarrhea.
  
  
  CONCLUSIONS
  Exenatide BID and QW improved glycemic control, including PPG, in Asian and White patients with T2DM. With exenatide BID, Asian patients exhibited significantly greater reductions in HbA1c and PPG than White patients. Both exenatide formulations were well tolerated in both groups.
authors.affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung No. 160, Section 3, Chung Kang Road, Taichung 407, Taiwan; School of Medicine, National Yang-Ming University, No. 155, Section 2, Linong St, Beitou District, Taipei City 112, Taiwan; College of Medicine, National Defence Medical Center, No. 161, Section 6, Minquan E Rd, Neihu District, Taipei City 114, Taiwan. Electronic address: whhsheu@vghtc.gov.tw.
authors.forename: Wayne H-H
authors.initials: WH
authors.lastname: Sheu
authors.affiliation: Amylin Pharmaceuticals, LLC, 9360 Towne Centre Dr., San Diego, CA 92121, USA. Electronic address: stevenbrunell@gmail.com.
authors.forename: Steven C
authors.initials: SC
authors.lastname: Brunell
authors.affiliation: Amylin Pharmaceuticals, LLC, 9360 Towne Centre Dr., San Diego, CA 92121, USA. Electronic address: ekblase@gmail.com.
authors.forename: Erich
authors.initials: E
authors.lastname: Blase
mesh_terms: D044466:Asian People / Q000706:statistics & numerical data*; D001786:Blood Glucose / Q000032:analysis*; D001835:Body Weight; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000208:ethnology*; D000077270:Exenatide; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010455:Peptides / Q000627:therapeutic use*; D019518:Postprandial Period; D044469:Racial Groups; D012189:Retrospective Studies; D016896:Treatment Outcome; D014688:Venoms / Q000627:therapeutic use*; D044465:White People / Q000706:statistics & numerical data*
chemical_list: D001786:Blood Glucose; D000077270:Exenatide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D010455:Peptides; D014688:Venoms
keywords: Asian race; Exenatide; Glycemic control; Post-prandial glucose; Type 2 diabetes