title: Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea.
abstract: OBJECTIVE
  To evaluate the efficacy of exenatide in Asian patients with type 2 diabetes (T2D) inadequately controlled with oral agents.
  
  
  METHODS
  Patients taking metformin (MET) alone or with a sulphonylurea (SU) were randomly assigned to exenatide 5 microg then 10 microg twice-daily for 4 and 12 weeks, respectively, or placebo. The primary endpoint was baseline to endpoint HbA(1c) change.
  
  
  RESULTS
  466 patients (age 54+/-9 years, weight 68.7+/-11.2 kg, BMI 26.3+/-3.3 kg/m(2), and HbA(1c) 8.3+/-1.1%; mean+/-S.D.) were enrolled in the full analysis set. Endpoint HbA(1c) reduction (mean [95% CI]) with exenatide was superior to placebo (-1.2 [-1.3, -1.1]% vs. -0.4 [-0.5, -0.2]%, p<0.001). More exenatide- than placebo-treated patients achieved HbA(1c) <or=7% (48% vs. 17%, p<0.001). At endpoint, weight reduction was greater with exenatide (-1.2 [-1.5, -0.9]kg) than placebo (-0.1 [-0.3, 0.2]kg), p<0.001. Nausea, generally mild-to-moderate, was the most common adverse event with exenatide (25% vs. 1% with placebo). The incidence of symptomatic hypoglycaemia with exenatide and placebo were 36% and 9%, respectively (p<0.001). Hypoglycaemia rates (events/patient-year) for patients taking exenatide with MET or MET and SU were 1.8 (0.9, 3.7) and 4.7 (3.5, 6.5), respectively.
  
  
  CONCLUSIONS
  Exenatide treatment improved glycaemic control in Asian patients with T2D and had a similar safety profile as in non-Asian patients.
authors.affiliation: Department of Endocrinology, Peking University First Hospital, Beijing, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Gao
authors.forename: Kun Ho
authors.initials: KH
authors.lastname: Yoon
authors.forename: Lee-Ming
authors.initials: LM
authors.lastname: Chuang
authors.forename: Viswanathan
authors.initials: V
authors.lastname: Mohan
authors.forename: Guang
authors.initials: G
authors.lastname: Ning
authors.forename: Sanjiv
authors.initials: S
authors.lastname: Shah
authors.forename: Hak Chul
authors.initials: HC
authors.lastname: Jang
authors.forename: Ta-Jen
authors.initials: TJ
authors.lastname: Wu
authors.forename: Don
authors.initials: D
authors.lastname: Johns
authors.forename: Justin
authors.initials: J
authors.lastname: Northrup
authors.forename: Robert
authors.initials: R
authors.lastname: Brodows
mesh_terms: D044466:Asian People; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000208:ethnology; D000077270:Exenatide; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D010455:Peptides / Q000627:therapeutic use*; D013453:Sulfonylurea Compounds / Q000627:therapeutic use; D014688:Venoms / Q000627:therapeutic use*
chemical_list: D007004:Hypoglycemic Agents; D010455:Peptides; D013453:Sulfonylurea Compounds; D014688:Venoms; D008687:Metformin; D000077270:Exenatide