PMID- 32219329
OWN - NLM
STAT- MEDLINE
DCOM- 20210201
LR  - 20210201
IS  - 1945-7197 (Electronic)
IS  - 0021-972X (Linking)
VI  - 105
IP  - 6
DP  - 2020 Jun 1
TI  - Randomized 52-week Phase 2 Trial of Albiglutide Versus Placebo in Adult Patients 
      With Newly Diagnosed Type 1 Diabetes.
LID - dgaa149 [pii]
LID - 10.1210/clinem/dgaa149 [doi]
AB  - CONTEXT: GLP-1 receptor agonists are an established therapy in patients with type 
      2 diabetes; however, their role in type 1 diabetes remains to be determined. 
      OBJECTIVE: Determine efficacy and safety of once-weekly albiglutide 30 mg 
      (up-titration to 50 mg at week 6) versus placebo together with insulin in 
      patients with new-onset type 1 diabetes and residual insulin production. DESIGN: 
      52-week, randomized, phase 2 study (NCT02284009). METHODS: A prespecified 
      Bayesian approach, incorporating placebo data from a prior study, allowed for 3:1 
      (albiglutide:placebo) randomization. The primary endpoint was 52-week change from 
      baseline in mixed meal tolerance test (MMTT) stimulated 2-h plasma C-peptide area 
      under the curve (AUC). Secondary endpoints included metabolic measures and 
      pharmacokinetics of albiglutide. RESULTS: 12/17 (70.6%, placebo) and 40/50 
      (80.0%, albiglutide) patients completed the study. Within our study, mean 
      (standard deviation) change from baseline to week 52 in MMTT-stimulated 2-h 
      plasma C-peptide AUC was -0.16 nmol/L (0.366) with placebo and -0.13 nmol/L 
      (0.244) with albiglutide. For the primary Bayesian analysis (including prior 
      study data) the posterior treatment difference (95% credible interval) was 
      estimated at 0.12 nmol/L (0-0.24); the probability of a difference >/=0.2 nmol/L 
      between treatments was low (0.097). A transient significant difference in maximum 
      C-peptide was seen at week 28. Otherwise, no significant secondary endpoint 
      differences were noted. On-therapy adverse events were reported in 82.0% 
      (albiglutide) and 76.5% (placebo) of patients. CONCLUSION: In newly diagnosed 
      patients with type 1 diabetes, albiglutide 30 to 50 mg weekly for 1 year had no 
      appreciable effect on preserving residual beta-cell function versus placebo.
CI  - (c) Endocrine Society 2020. All rights reserved. For permissions, please e-mail: 
      journals.permissions@oup.com.
FAU - Pozzilli, Paolo
AU  - Pozzilli P
AD  - University of Rome, Campus Bio-Medico, Rome, Italy.
FAU - Bosi, Emanuele
AU  - Bosi E
AD  - Diabetes Research Institute, IRCCS San Raffaele and San Raffaele Vita Salute 
      University, Milan, Italy.
FAU - Cirkel, Deborah
AU  - Cirkel D
AD  - GlaxoSmithKline, Stevenage, Hertfordshire, UK.
FAU - Harris, Julia
AU  - Harris J
AD  - GlaxoSmithKline, Uxbridge, Middlesex, UK.
FAU - Leech, Nicola
AU  - Leech N
AD  - The Newcastle upon Tyne Hospitals Foundation Trust, Newcastle upon Tyne, UK.
FAU - Tinahones, Francisco J
AU  - Tinahones FJ
AD  - Department of Endocrinology and Nutrition, Virgen de la Victoria Hospital 
      (IBIMA), Malaga University. Centro de Investigacion Biomedica en Red de la 
      Fisiopatologia de la Obesidad y Nutricion (CIBEROBN), Instituto de Salud Carlos 
      III (ISCIII), Malaga, Spain.
FAU - Vantyghem, Marie-Christine
AU  - Vantyghem MC
AD  - University of Lille, CHU Lille, Endocrinology, Diabetology and Metabolism 
      Department, Inserm U1190-European Genomic Institute for Diabetes, Lille, France.
FAU - Vlasakakis, Georgios
AU  - Vlasakakis G
AD  - GlaxoSmithKline, Uxbridge, Middlesex, UK.
FAU - Ziegler, Anette-Gabriele
AU  - Ziegler AG
AD  - Institute of Diabetes Research, Helmholtz Zentrum Munchen, Germany, and 
      Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der 
      Isar, Munich, Germany.
FAU - Janmohamed, Salim
AU  - Janmohamed S
AD  - GlaxoSmithKline, Uxbridge, Middlesex, UK.
LA  - eng
SI  - ClinicalTrials.gov/NCT02284009
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Clin Endocrinol Metab
JT  - The Journal of clinical endocrinology and metabolism
JID - 0375362
RN  - 0 (Biomarkers)
RN  - 0 (Blood Glucose)
RN  - 0 (Incretins)
RN  - 5E7U48495E (rGLP-1 protein)
RN  - 89750-14-1 (Glucagon-Like Peptide 1)
SB  - IM
CIN - J Clin Endocrinol Metab. 2020 Aug 1;105(8):. PMID: 32485735
MH  - Adolescent
MH  - Adult
MH  - Biomarkers/*analysis
MH  - Blood Glucose/analysis
MH  - Diabetes Mellitus, Type 1/*drug therapy/metabolism/pathology
MH  - Female
MH  - Follow-Up Studies
MH  - Glucagon-Like Peptide 1/*analogs & derivatives/therapeutic use
MH  - Humans
MH  - Incretins/*therapeutic use
MH  - Male
MH  - Prognosis
MH  - Young Adult
OTO - NOTNLM
OT  - GLP-1 receptor agonist
OT  - albiglutide
OT  - insulin
OT  - type 1 diabetes mellitus
EDAT- 2020/03/29 06:00
MHDA- 2021/02/02 06:00
CRDT- 2020/03/29 06:00
PHST- 2019/09/13 00:00 [received]
PHST- 2020/03/24 00:00 [accepted]
PHST- 2020/03/29 06:00 [pubmed]
PHST- 2021/02/02 06:00 [medline]
PHST- 2020/03/29 06:00 [entrez]
AID - 5812593 [pii]
AID - 10.1210/clinem/dgaa149 [doi]
PST - ppublish
SO  - J Clin Endocrinol Metab. 2020 Jun 1;105(6):dgaa149. doi: 10.1210/clinem/dgaa149.