PMID- 27852119
OWN - NLM
STAT- MEDLINE
DCOM- 20170928
LR  - 20221207
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 33
IP  - 3
DP  - 2017 Mar
TI  - 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.
PG  - 431-438
LID - 10.1080/03007995.2016.1261817 [doi]
AB  - OBJECTIVE: 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). RESEARCH DESIGN AND METHODS: 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 alpha-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 HbA(1c) and fasting 
      plasma glucose (FPG), proportion of patients achieving HbA(1c) </=7.0%, and 
      withdrawals due to hyperglycemia. RESULTS: 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 HbA(1c) was 8.1%. Mean decreases from baseline in HbA(1c) 
      were observed with the addition of albiglutide to thiazolidinediones (-1.42%), 
      alpha-glucosidase inhibitors (-1.39%), sulfonylureas (-1.04%), glinides (-0.95%), and 
      biguanides (-0.94%). HbA(1c) of <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. CONCLUSIONS: 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.
FAU - Okuda, Inaha
AU  - Okuda I
AD  - a GlaxoSmithKline , Tokyo , Japan.
FAU - Wilson, Timothy H
AU  - Wilson TH
AD  - b PAREXEL International, Research Triangle Park , NC , USA.
FAU - Yue, Lin
AU  - Yue L
AD  - c GlaxoSmithKline , Collegeville , PA , USA.
FAU - Nakajima, Hiromu
AU  - Nakajima H
AD  - a GlaxoSmithKline , Tokyo , Japan.
FAU - Carr, Molly C
AU  - Carr MC
AD  - c GlaxoSmithKline , Collegeville , PA , USA.
FAU - Tsuboi, Maho
AU  - Tsuboi M
AD  - a GlaxoSmithKline , Tokyo , Japan.
FAU - Nino, Antonio
AU  - Nino A
AD  - c GlaxoSmithKline , Collegeville , PA , USA.
FAU - Seino, Yutaka
AU  - Seino Y
AD  - d Kansai Electric Power Hospital , Osaka , Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT01777282
PT  - Journal Article
DEP - 20161221
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Blood Glucose)
RN  - 0 (Glucagon-Like Peptide-1 Receptor)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Recombinant Proteins)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 5E7U48495E (rGLP-1 protein)
RN  - 89750-14-1 (Glucagon-Like Peptide 1)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Blood Glucose/analysis
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Female
MH  - Glucagon-Like Peptide 1/adverse effects/*analogs & derivatives/therapeutic use
MH  - Glucagon-Like Peptide-1 Receptor/*agonists
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hyperglycemia/drug therapy
MH  - Hypoglycemia/chemically induced
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Recombinant Proteins/therapeutic use
OTO - NOTNLM
OT  - Albiglutide
OT  - GLP-1
OT  - Japanese population
OT  - type 2 diabetes mellitus
EDAT- 2016/11/18 06:00
MHDA- 2017/09/29 06:00
CRDT- 2016/11/18 06:00
PHST- 2016/11/18 06:00 [pubmed]
PHST- 2017/09/29 06:00 [medline]
PHST- 2016/11/18 06:00 [entrez]
AID - 10.1080/03007995.2016.1261817 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2017 Mar;33(3):431-438. doi: 10.1080/03007995.2016.1261817. 
      Epub 2016 Dec 21.