title: Exenatide twice daily versus premixed insulin aspart 70/30 in metformin-treated patients with type 2 diabetes: a randomized 26-week study on glycemic control and hypoglycemia.
abstract: OBJECTIVE
  Hypoglycemia causes recurrent morbidity in patients with type 2 diabetes. This study evaluated if exenatide twice daily (BID) was noninferior to premixed insulin aspart 70/30 BID (PIA) for glycemic control and associated with less hypoglycemia.
  
  
  METHODS
  In this open-label study, metformin-treated adults with type 2 diabetes were randomized to 26-week treatment with exenatide BID (4 weeks 5 μg, then 10 μg) or PIA.
  
  
  RESULTS
  Exenatide BID (n = 181) was noninferior to PIA (n = 173) for A1C control (least squares [LS] mean change -1.0 vs. -1.14%; difference [95% CI] 0.14 [-0.003 to 0.291]) and associated with a lower risk for hypoglycemia (8.0 vs. 20.5%, P < 0.05). LS mean weight decreased by 4.1 kg and increased by 1.0 kg with PIA (P < 0.001). A total of 39.2 vs. 20.8% of patients reached the composite end point of A1C <7.0%, no weight gain, and no hypoglycemia (P < 0.001; post hoc analysis).
  
  
  CONCLUSIONS
  In metformin-treated patients, exenatide BID was noninferior to PIA for glycemic control but superior for hypoglycemia and weight control.
authors.affiliation: Department of Medicine IV, University Hospital of Tübingen, Tübingen, Germany.
authors.forename: Baptist
authors.initials: B
authors.lastname: Gallwitz
authors.forename: Michael
authors.initials: M
authors.lastname: Böhmer
authors.forename: Thomas
authors.initials: T
authors.lastname: Segiet
authors.forename: Andrea
authors.initials: A
authors.lastname: Mölle
authors.forename: Karsten
authors.initials: K
authors.lastname: Milek
authors.forename: Bernd
authors.initials: B
authors.lastname: Becker
authors.forename: Karin
authors.initials: K
authors.lastname: Helsberg
authors.forename: Helmut
authors.initials: H
authors.lastname: Petto
authors.forename: Natalie
authors.initials: N
authors.lastname: Peters
authors.forename: Oliver
authors.initials: O
authors.lastname: Bachmann
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D000077270:Exenatide; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000188:drug therapy; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D007328:Insulin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D061267:Insulin Aspart; D008687:Metformin / Q000008:administration & dosage* / Q000627:therapeutic use*; D008875:Middle Aged; D010455:Peptides / Q000008:administration & dosage* / Q000627:therapeutic use*; D016896:Treatment Outcome; D014688:Venoms / Q000008:administration & dosage* / Q000627:therapeutic use*
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin; D010455:Peptides; D014688:Venoms; D008687:Metformin; D000077270:Exenatide; D061267:Insulin Aspart