PMID- 27102969
OWN - NLM
STAT- MEDLINE
DCOM- 20170926
LR  - 20171127
IS  - 1520-7560 (Electronic)
IS  - 1520-7552 (Linking)
VI  - 32
IP  - 8
DP  - 2016 Nov
TI  - Efficacy and safety of dulaglutide in the treatment of type 2 diabetes: a 
      comprehensive review of the dulaglutide clinical data focusing on the AWARD phase 
      3 clinical trial program.
PG  - 776-790
LID - 10.1002/dmrr.2810 [doi]
AB  - Dulaglutide (DU) is a once weekly glucagon-like peptide-1 receptor agonist (GLP-1 
      RA) approved for the treatment of type 2 diabetes mellitus (T2DM). Glycaemic 
      efficacy and safety characteristics of dulaglutide have been assessed in six 
      Phase 3 studies in the AWARD program. The objective of this review article is to 
      summarize these results from the six completed AWARD studies. At the primary 
      endpoint, in five of the six studies, once weekly dulaglutide 1.5 mg was superior 
      to the active comparator [exenatide, insulin glargine (two studies), metformin, 
      and sitagliptin], with a greater proportion of patients reaching glycated 
      hemoglobin A1c (HbA1c) targets of <7.0% (53.0 mmol/mol) and </=6.5% 
      (47.5 mmol/mol). Dulaglutide 1.5 mg was non-inferior to liraglutide in AWARD-6. 
      Once weekly dulaglutide 0.75 mg was evaluated in five of these trials and 
      demonstrated superiority to the active comparator in four of five AWARD studies 
      (exenatide, glargine, metformin, and sitagliptin), and non-inferiority to 
      glargine in the AWARD-2 study. Similar to other GLP-1 receptor agonists, 
      treatment with dulaglutide was associated with weight loss or attenuation of 
      weight gain and low rates of hypoglycaemia when used alone or with 
      non-insulin-secretagogue therapy. The most frequently reported adverse events 
      were gastrointestinal, including nausea, vomiting, and diarrhea. The incidence of 
      dulaglutide antidrug antibody formation was 1-2.8% with rare injection site 
      reactions. In conclusion, dulaglutide is an effective treatment for T2DM and has 
      an acceptable tolerability and safety profile. Copyright (c) 2016 John Wiley & 
      Sons, Ltd.
CI  - Copyright (c) 2016 John Wiley & Sons, Ltd.
FAU - Jendle, Johan
AU  - Jendle J
AD  - School of Medical Sciences, Orebro University, Orebro, Sweden. 
      johan.jendle@oru.se.
FAU - Grunberger, George
AU  - Grunberger G
AD  - Grunberger Diabetes Institute, Bloomfield Hills, MI, USA.
FAU - Blevins, Thomas
AU  - Blevins T
AD  - Texas Diabetes and Endocrinology, Austin, TX, USA.
FAU - Giorgino, Francesco
AU  - Giorgino F
AD  - University of Bari Aldo Moro, Bari, Italy.
FAU - Hietpas, Ryan T
AU  - Hietpas RT
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Botros, Fady T
AU  - Botros FT
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
DEP - 20160515
PL  - England
TA  - Diabetes Metab Res Rev
JT  - Diabetes/metabolism research and reviews
JID - 100883450
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Immunoglobulin Fc Fragments)
RN  - 0 (Recombinant Fusion Proteins)
RN  - 62340-29-8 (Glucagon-Like Peptides)
RN  - WTT295HSY5 (dulaglutide)
SB  - IM
MH  - Animals
MH  - Clinical Trials as Topic
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Glucagon-Like Peptides/*analogs & derivatives/therapeutic use
MH  - Humans
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Immunoglobulin Fc Fragments/*therapeutic use
MH  - Recombinant Fusion Proteins/*therapeutic use
MH  - Safety
MH  - Treatment Outcome
OTO - NOTNLM
OT  - GLP-1 receptor agonist
OT  - dulaglutide
OT  - type 2 Diabetes
EDAT- 2016/11/05 06:00
MHDA- 2017/09/28 06:00
CRDT- 2016/04/23 06:00
PHST- 2015/10/08 00:00 [received]
PHST- 2016/03/18 00:00 [revised]
PHST- 2016/04/13 00:00 [accepted]
PHST- 2016/11/05 06:00 [pubmed]
PHST- 2017/09/28 06:00 [medline]
PHST- 2016/04/23 06:00 [entrez]
AID - 10.1002/dmrr.2810 [doi]
PST - ppublish
SO  - Diabetes Metab Res Rev. 2016 Nov;32(8):776-790. doi: 10.1002/dmrr.2810. Epub 2016 
      May 15.