title: Use of concomitant glucose-lowering therapies and associated treatment results observed in clinical trials of twice-daily exenatide.
abstract: OBJECTIVE
  To explore, by post hoc analyses of pooled data, the efficacy and safety of the use of exenatide twice daily (BID) in patients stratified by baseline glucose-lowering therapies.
  
  
  METHODS
  Patients with type 2 diabetes from long-term randomized controlled trials who were treated with exenatide BID were classified into concomitant medication groups on the basis of background treatment (diet and exercise only, metformin only, sulfonylurea only, thiazolidinedione only, metformin + sulfonylurea, metformin + thiazolidinedione, or insulin with or without other oral antihyperglycemic medications). Seventeen studies were included in the analyses (N = 2,096).
  
  
  RESULTS
  In these analyses of patients treated with exenatide BID for 12 to 30 weeks, there were significant decreases from baseline in hemoglobin A(1c) (A1C) and fasting glucose levels in all groups and significant decreases from baseline in body weight in all groups except the thiazolidinedione-only group. The decrease in A1C appeared to be greater in the insulin group than in the other groups, likely because the insulin dose was titrated whereas doses of concomitant antihyperglycemic medications were generally not titrated. Overall, changes in blood pressure and lipids were small. Across all groups, the most common adverse effects were gastrointestinal events. Hypoglycemia was more common in the sulfonylurea-only, metformin + sulfonylurea, and insulin groups than it was in the other concomitant medication groups.
  
  
  CONCLUSIONS
  The use of exenatide BID across a wide range of background therapies was associated with reductions in A1C, fasting glucose, and body weight. Gastrointestinal adverse events were common.
authors.affiliation: Amylin Pharmaceuticals, Inc., San Diego, California 92121, USA. Richard.Pencek@amylin.com
authors.forename: Richard
authors.initials: R
authors.lastname: Pencek
authors.forename: Steven C
authors.initials: SC
authors.lastname: Brunell
authors.forename: Yan
authors.initials: Y
authors.lastname: Li
authors.forename: Byron J
authors.initials: BJ
authors.lastname: Hoogwerf
authors.forename: James
authors.initials: J
authors.lastname: Malone
mesh_terms: D000328:Adult; D000368:Aged; D001794:Blood Pressure / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination / Q000009:adverse effects; D000077270:Exenatide; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control; D007003:Hypoglycemia / Q000139:chemically induced / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic; D014688:Venoms / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D015431:Weight Loss / Q000187:drug effects
chemical_list: D000077270:Exenatide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008055:Lipids; D010455:Peptides; D014688:Venoms; C517652:hemoglobin A1c protein, human