title: Clinical outcomes of concomitant therapy of exenatide twice daily and basal insulin in patients with type 2 diabetes mellitus: a retrospective database analysis in the United States.
abstract: OBJECTIVE
  To examine the clinical effectiveness of concomitant therapy of exenatide twice daily and basal insulin in patients with type 2 diabetes mellitus in the United States.
  
  
  METHODS
  Data from adults with type 2 diabetes were selected from an electronic medical record database. Concomitant therapy was defined as a basal insulin prescription within 6 months before or after an exenatide prescription between May 2005 and April 2009. Upon initiation, patients were treated with both medications. Clinical effectiveness was measured as mean changes in hemoglobin A1c (primary outcome), body weight, body mass index, blood pressure, and lipid values from a 6-month baseline to mean-adjusted values in a 12-month follow-up period. These changes were assessed by a bootstrapping test.
  
  
  RESULTS
  There were 1752 patients (mean age, 57 years) who initiated concomitant therapy (75% added exenatide to basal insulin, 25% added basal insulin to exenatide). Patients achieved significant mean reductions in hemoglobin A1c (0.5%), body weight (1.8 kg), body mass index (0.6 kg/m2), diastolic blood pressure (0.5 mm Hg), and various lipid measures (all P<.05). Hemoglobin A1c reduction was consistent irrespective of the treatment order. However, body weight, body mass index, and blood pressure reductions were observed in only patients who added exenatide to basal insulin.
  
  
  CONCLUSIONS
  Overall, exenatide and basal insulin concomitant therapy was associated with significant reductions in hemoglobin A1c, body weight, body mass index, diastolic blood pressure, and lipids in a large, diverse patient population treated in ambulatory care settings in the United States. In the subgroup analysis, body weight, body mass index, and diastolic blood pressure reductions were observed in only patients who added exenatide to basal insulin.
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana, USA.
authors.forename: Manjiri
authors.initials: M
authors.lastname: Pawaskar
authors.forename: Qian
authors.initials: Q
authors.lastname: Li
authors.forename: Byron J
authors.initials: BJ
authors.lastname: Hoogwerf
authors.forename: Matthew W
authors.initials: MW
authors.lastname: Reynolds
authors.forename: Lauren J
authors.initials: LJ
authors.lastname: Lee
authors.forename: Vivian
authors.initials: V
authors.lastname: Fonseca
mesh_terms: D000328:Adult; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism; D004334:Drug Administration Schedule; D000077270:Exenatide; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D007328:Insulin / Q000008:administration & dosage* / Q000627:therapeutic use*; D008875:Middle Aged; D010455:Peptides / Q000008:administration & dosage* / Q000627:therapeutic use*; D012189:Retrospective Studies; D014481:United States; D014688:Venoms / Q000008:administration & dosage* / Q000627:therapeutic use*
chemical_list: D000077270:Exenatide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D010455:Peptides; D014688:Venoms