PMID- 31004676
OWN - NLM
STAT- MEDLINE
DCOM- 20190822
LR  - 20221207
IS  - 1872-8227 (Electronic)
IS  - 0168-8227 (Linking)
VI  - 152
DP  - 2019 Jun
TI  - Efficacy and safety of an albiglutide liquid formulation compared with the 
      lyophilized formulation: A 26-week randomized, double-blind, repeat-dose study in 
      patients with type 2 diabetes mellitus.
PG  - 125-134
LID - S0168-8227(18)31627-9 [pii]
LID - 10.1016/j.diabres.2019.04.018 [doi]
AB  - AIMS: Compare the efficacy and safety of albiglutide from a ready-to-use, 
      single-dose, auto-injector system with the lyophilized product in patients with 
      type 2 diabetes mellitus (T2DM). METHODS: In this phase 3 study, 308 patients 
      between 18 and 80 years with T2DM and experiencing inadequate glycemic control on 
      their current regimen of diet/exercise alone or in combination with metformin 
      were randomized 1:1 to weekly injections for 26 weeks with an active albiglutide 
      auto-injector and placebo lyophilized dual-chamber cartridge (DCC) pen injector 
      (n = 154) or active albiglutide lyophilized DCC pen injector and placebo liquid 
      auto-injector (n = 154). Participants received liquid or lyophilized albiglutide 
      30 mg for 4 weeks, and then 50 mg for the remaining 22 weeks. Change in HbA(1c) 
      and fasting plasma glucose (FPG), pharmacokinetics, and safety were assessed. 
      RESULTS: In the albiglutide liquid and lyophilized drug product groups, 55.6% 
      (85/153) and 45.5% of patients (70/154) had a baseline HbA(1c) >/= 8.0%, 
      respectively. The model-adjusted least squares (LS) mean change in HbA(1c) from 
      baseline at week 26 was -1.1% (95% CI: -1.3, -1.0) and -1.2% (95% CI: -1.3, -1.0; 
      noninferiority P = 0.0002) in the albiglutide liquid and lyophilized product 
      groups, respectively. Similarly, the model-adjusted LS mean change in FPG from 
      baseline at week 26 in the albiglutide liquid and lyophilized product groups was 
      -2.2 (95% CI: -2.6, -1.8) mmol/L and -1.9 (95% CI: -2.3, -1.5) mmol/L, 
      respectively. No new safety concerns were identified. CONCLUSION: Change from 
      baseline in HbA(1c) for albiglutide liquid was noninferior to lyophilized drug 
      product in patients with T2DM.
CI  - Copyright (c) 2019 Elsevier B.V. All rights reserved.
FAU - Shaddinger, Bonnie C
AU  - Shaddinger BC
AD  - Clinical Development, GlaxoSmithKline, Collegeville, PA, USA. Electronic address: 
      Bonnie.C.Shaddinger@gsk.com.
FAU - Soffer, Joseph
AU  - Soffer J
AD  - Clinical Development, GlaxoSmithKline, Collegeville, PA, USA.
FAU - Vlasakakis, Georgios
AU  - Vlasakakis G
AD  - Research and Development, GlaxoSmithKline, London, UK.
FAU - Shabbout, Mayadah
AU  - Shabbout M
AD  - Research and Development, GlaxoSmithKline, King of Prussia, PA, USA.
FAU - Weston, Cindy
AU  - Weston C
AD  - Research and Development, GlaxoSmithKline, King of Prussia, PA, USA.
FAU - Nino, Antonio
AU  - Nino A
AD  - Clinical Development, GlaxoSmithKline, Collegeville, PA, USA.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20190418
PL  - Ireland
TA  - Diabetes Res Clin Pract
JT  - Diabetes research and clinical practice
JID - 8508335
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Solutions)
RN  - 5E7U48495E (rGLP-1 protein)
RN  - 89750-14-1 (Glucagon-Like Peptide 1)
RN  - 9100L32L2N (Metformin)
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Blood Glucose/drug effects/metabolism
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Compounding
MH  - Female
MH  - Freeze Drying
MH  - Glucagon-Like Peptide 1/administration & dosage/adverse effects/*analogs & 
      derivatives
MH  - Glycated Hemoglobin/analysis/drug effects/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage/adverse effects
MH  - Male
MH  - Metformin/administration & dosage/adverse effects
MH  - Middle Aged
MH  - Solutions
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Albiglutide
OT  - GLP-1 receptor agonist
OT  - Liquid formulation
OT  - Type 2 diabetes mellitus
EDAT- 2019/04/21 06:00
MHDA- 2019/08/23 06:00
CRDT- 2019/04/21 06:00
PHST- 2018/11/08 00:00 [received]
PHST- 2019/03/07 00:00 [revised]
PHST- 2019/04/12 00:00 [accepted]
PHST- 2019/04/21 06:00 [pubmed]
PHST- 2019/08/23 06:00 [medline]
PHST- 2019/04/21 06:00 [entrez]
AID - S0168-8227(18)31627-9 [pii]
AID - 10.1016/j.diabres.2019.04.018 [doi]
PST - ppublish
SO  - Diabetes Res Clin Pract. 2019 Jun;152:125-134. doi: 
      10.1016/j.diabres.2019.04.018. Epub 2019 Apr 18.