title: Lixisenatide Therapy in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Antidiabetic Treatment: The GetGoal-O Randomized Trial.
abstract: To evaluate the efficacy and safety of lixisenatide versus placebo on glycemic control in older patients with type 2 diabetes uncontrolled on their current antidiabetic treatment.
  
  
  
  In this phase III, double-blind, randomized, placebo-controlled, two-arm, parallel-group, multicenter trial, patients aged ≥70 years were randomized to receive once-daily lixisenatide 20 μg or placebo before breakfast concomitantly with their existing antidiabetic therapy (including insulin) for 24 weeks. Patients at risk for malnutrition or with moderate to severe cognitive impairment were excluded. The primary end point was absolute change in HbA1cfrom baseline to week 24. Secondary end points included change from baseline to week 24 in 2-h postprandial plasma glucose (PPG) and body weight.
  
  
  
  A total of 350 patients were randomized. HbA1cdecreased substantially with lixisenatide (-0.57% [6.2 mmol/mol]) compared with placebo (+0.06% [0.7 mmol/mol]) from baseline to week 24 (P< 0.0001). Mean reduction in 2-h PPG was significantly greater with lixisenatide (-5.12 mmol/L) than with placebo (-0.07 mmol/L;P< 0.0001). A greater decrease in body weight was observed with lixisenatide (-1.47 kg) versus placebo (-0.16 kg;P< 0.0001). The safety profile of lixisenatide in this older population, including rates of nausea and vomiting, was consistent with that observed in other lixisenatide studies. Hypoglycemia was reported in 17.6% of patients with lixisenatide versus 10.3% with placebo.
  
  
  
  In nonfrail older patients uncontrolled on their current antidiabetic treatment, lixisenatide was superior to placebo in HbA1creduction and in targeting postprandial hyperglycemia, with no unexpected safety findings.
authors.affiliation: University of British Columbia, Vancouver, British Columbia, Canada meneilly@mail.ubc.ca.
authors.forename: Graydon S
authors.identifier: 0000-0002-2442-5260
authors.initials: GS
authors.lastname: Meneilly
authors.affiliation: Sanofi, Chilly-Mazarin, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Roy-Duval
authors.affiliation: Diabetessaar-Center, Saarlouis, Germany.
authors.forename: Hasan
authors.initials: H
authors.lastname: Alawi
authors.affiliation: Scripps Whittier Diabetes Institute, La Jolla, CA.
authors.forename: George
authors.initials: G
authors.lastname: Dailey
authors.affiliation: University Hospital of Ferrol, Ferrol (Galicia), Spain.
authors.forename: Diego
authors.initials: D
authors.lastname: Bellido
authors.affiliation: Hospital de la Ribera, Alzira, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Trescoli
authors.affiliation: Centro de Investigación en Diabetes, Obesidad y Nutrición, Lima, Peru.
authors.forename: Helard
authors.initials: H
authors.lastname: Manrique Hurtado
authors.affiliation: BMD Consulting, Inc., Somerset, NJ.
authors.forename: Hailing
authors.initials: H
authors.lastname: Guo
authors.affiliation: Sanofi, Chilly-Mazarin, France.
authors.forename: Valerie
authors.initials: V
authors.lastname: Pilorget
authors.affiliation: Sanofi, Bridgewater, NJ.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Perfetti
authors.affiliation: Townhead Surgery, Irvine, U.K.
authors.forename: Hamish
authors.initials: H
authors.lastname: Simpson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000378:metabolism; D001835:Body Weight; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D006943:Hyperglycemia / Q000188:drug therapy; D007003:Hypoglycemia / Q000209:etiology; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage; D008297:Male; D009325:Nausea / Q000209:etiology; D010455:Peptides / Q000008:administration & dosage*; D019518:Postprandial Period; D014839:Vomiting / Q000209:etiology; D000067758:Glucagon-Like Peptide-2 Receptor
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D010455:Peptides; C479460:lixisenatide; D000067758:Glucagon-Like Peptide-2 Receptor