title: Safety and efficacy of once-weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes over 84 weeks.
abstract: OBJECTIVE
  We recently reported that after 26 weeks, exenatide once weekly (EQW) resulted in superior A1C reduction, reduced hypoglycemia, and progressive weight loss compared with daily insulin glargine (IG) in patients with type 2 diabetes who were taking metformin alone or with sulfonylurea. This 84-week extension study assessed the long-term safety and efficacy of EQW versus IG.
  
  
  METHODS
  This multicenter, open-label, randomized, two-arm, parallel trial assessed change in A1C, proportions of patients achieving A1C <7.0 and ≤6.5%, body weight, incidence of hypoglycemia, and overall safety.
  
  
  RESULTS
  Of 415 patients who completed 26 weeks, 390 (194 EQW and 196 IG patients) entered the extension study. At 84 weeks, A1C decreased from baseline (8.3%) by -1.2% for EQW vs. -1.0% for IG (P = 0.029). The proportions of patients who achieved end point A1C targets <7.0 and ≤6.5% were 44.6% for EQW patients vs. 36.8% for IG patients (P = 0.084) and 31.3% for EQW patients vs. 20.2% for IG patients (P = 0.009), respectively. Patients taking EQW lost 2.1 kg of body weight, whereas those taking IG gained 2.4 kg (P < 0.001). Among patients taking metformin plus sulfonylurea, the incidence of minor hypoglycemia was 24% for EQW patients vs. 54% for IG patients (P < 0.001); among patients taking metformin alone, it was 8% for EQW patients vs. 32% for IG patients (P < 0.001). Among adverse events occurring in ≥5% of patients, diarrhea and nausea occurred more frequently (P < 0.05) in the EQW group than in the IG group (12 vs. 6% and 15 vs. 1%, respectively).
  
  
  CONCLUSIONS
  After 84 weeks, patients treated with EQW continued to experience better glycemic control with sustained overall weight loss and a lower risk of hypoglycemia than patients treated with IG.
authors.affiliation: Diabetes Center,VU Medical Center, Amsterdam, The Netherlands. m.diamant@vumc.nl
authors.forename: Michaela
authors.initials: M
authors.lastname: Diamant
authors.forename: Luc
authors.initials: L
authors.lastname: Van Gaal
authors.forename: Stephen
authors.initials: S
authors.lastname: Stranks
authors.forename: Bruno
authors.initials: B
authors.lastname: Guerci
authors.forename: Leigh
authors.initials: L
authors.lastname: MacConell
authors.forename: Harry
authors.initials: H
authors.lastname: Haber
authors.forename: Jamie
authors.initials: J
authors.lastname: Scism-Bacon
authors.forename: Michael
authors.initials: M
authors.lastname: Trautmann
mesh_terms: D000465:Algorithms; D001786:Blood Glucose / Q000032:analysis / Q000378:metabolism; D002320:Cardiovascular Physiological Phenomena / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000378:metabolism / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D054796:Drug Dosage Calculations; D000077270:Exenatide; D005500:Follow-Up Studies; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting / Q000008:administration & dosage* / Q000009:adverse effects*; D010455:Peptides / Q000008:administration & dosage* / Q000009:adverse effects*; D013997:Time Factors; D017186:Titrimetry; D016896:Treatment Outcome; D014688:Venoms / Q000008:administration & dosage* / Q000009:adverse effects*
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D049528:Insulin, Long-Acting; D010455:Peptides; D014688:Venoms; D000069036:Insulin Glargine; D000077270:Exenatide