title: Albiglutide, a weekly GLP-1 receptor agonist, improves glycemic parameters in Japanese patients with type 2 diabetes over 1 year when added to single oral antidiabetic drugs.
abstract: To evaluate the safety and efficacy of once weekly albiglutide added to a single oral antidiabetic drug (OAD) in Japanese patients with inadequately controlled type 2 diabetes mellitus (T2DM).
  
  
  
  In this phase 3, 1 year study (NCT01777282), patients (N = 374) received albiglutide 30 mg plus a single OAD (sulfonylurea [n = 120], biguanide [n = 67)], glinide [n = 65], thiazolidinedione [n = 61], or α-glucosidase inhibitor [n = 61]). Albiglutide could be increased to 50 mg after Week 4, based on glycemic criteria. Primary endpoints were the incidence of adverse events (AEs) and hypoglycemia; secondary endpoints were changes from baseline at Week 52 in HbA1cand fasting plasma glucose (FPG), proportion of patients achieving HbA1c≤7.0%, and withdrawals due to hyperglycemia.
  
  
  
  On-therapy AEs occurred in 78.6% of patients and serious AEs in 2.1%. Common AEs were nasopharyngitis (32.6%), constipation (7.2%), and diabetic retinopathy (5.3%). No serious AEs occurred more than once or were reported in >1 patient. Hypoglycemia occurred in 6.4% of patients, mostly in the albiglutide + sulfonylurea (14.2%) and the albiglutide + glinide (6.2%) groups. Albiglutide was uptitrated in 53.2% of patients. Mean baseline HbA1cwas 8.1%. Mean decreases from baseline in HbA1cwere observed with the addition of albiglutide to thiazolidinediones (-1.42%), α-glucosidase inhibitors (-1.39%), sulfonylureas (-1.04%), glinides (-0.95%), and biguanides (-0.94%). HbA1cof <7% in >50% of patients and mean reductions in FPG were achieved in all groups. Mean changes from baseline in body weight ranged from +0.52 kg (albiglutide + thiazolidinedione) to -0.33 kg (albiglutide + biguanide). Limitations of the study included open label treatment that was not randomized.
  
  
  
  When combined with a single OAD in Japanese patients with inadequately controlled T2DM, albiglutide led to favorable changes in all glycemic parameters, with minor changes in body weight depending on the background OAD. No new safety concerns were noted.
authors.affiliation: a GlaxoSmithKline , Tokyo , Japan.
authors.forename: Inaha
authors.initials: I
authors.lastname: Okuda
authors.affiliation: b PAREXEL International, Research Triangle Park , NC , USA.
authors.forename: Timothy H
authors.initials: TH
authors.lastname: Wilson
authors.affiliation: c GlaxoSmithKline , Collegeville , PA , USA.
authors.forename: Lin
authors.initials: L
authors.lastname: Yue
authors.affiliation: a GlaxoSmithKline , Tokyo , Japan.
authors.forename: Hiromu
authors.initials: H
authors.lastname: Nakajima
authors.affiliation: c GlaxoSmithKline , Collegeville , PA , USA.
authors.forename: Molly C
authors.initials: MC
authors.lastname: Carr
authors.affiliation: a GlaxoSmithKline , Tokyo , Japan.
authors.forename: Maho
authors.initials: M
authors.lastname: Tsuboi
authors.affiliation: c GlaxoSmithKline , Collegeville , PA , USA.
authors.forename: Antonio
authors.initials: A
authors.lastname: Nino
authors.affiliation: d Kansai Electric Power Hospital , Osaka , Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Seino
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D052216:Glucagon-Like Peptide 1 / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000188:drug therapy; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000627:therapeutic use; D000097789:Glucagon-Like Peptide-1 Receptor Agonists
chemical_list: D001786:Blood Glucose; D052216:Glucagon-Like Peptide 1; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D011994:Recombinant Proteins; D000097789:Glucagon-Like Peptide-1 Receptor Agonists; C517652:hemoglobin A1c protein, human; C534611:rGLP-1 protein
keywords: Albiglutide; GLP-1; Japanese population; type 2 diabetes mellitus