PMID- 28284167 OWN - NLM STAT- MEDLINE DCOM- 20170626 LR - 20181202 IS - 1872-8227 (Electronic) IS - 0168-8227 (Linking) VI - 126 DP - 2017 Apr TI - Albiglutide for the treatment of type 2 diabetes mellitus: An integrated safety analysis of the HARMONY phase 3 trials. PG - 230-239 LID - S0168-8227(16)30730-6 [pii] LID - 10.1016/j.diabres.2017.02.017 [doi] AB - AIMS: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) stimulate the incretin system and lower glycaemic parameters in type 2 diabetes mellitus (T2DM). This analysis of clinical studies of up to 3years evaluated the safety of albiglutide, a GLP-1 RA, in people with T2DM. METHODS: Integrated safety analysis included seven phase-3 T2DM studies of albiglutide compared with placebo and/or active comparators (a dipeptidyl peptidase-4 inhibitor, GLP-1 RA, insulin, sulphonylurea, and thiazolidinedione). RESULTS: Studies of 32months (HARMONY 7), 1year (HARMONY 6), and 3years (HARMONY 1-5), reported similar rates of adverse events (AEs) (84.8%, 82.3%), and serious AEs (13.1%, 12.9%) between albiglutide and all comparators, respectively. AEs that did not differ between the groups included symptomatic or severe hypoglycaemia as well as nausea (12.0%, 11.3%) and vomiting (5.3%, 4.7%) for albiglutide and all comparators, respectively. According to the Medical Dictionary for Regulatory Activities preferred terms, only diarrhoea (13.7%, 9.9%), injection-site reaction (9.0%, 2.0%), and peripheral oedema (4.5%, 6.8%) had at least 2% difference between the albiglutide and all-comparator groups. In a similar integrated analysis, pancreatitis occurred more often with albiglutide (0.3%, 0.1%). Renal and cardiac function did not differ between the two groups. CONCLUSIONS: In an integrated analysis of seven phase 3 clinical trials, albiglutide-treated patients experienced frequencies of AEs (including cardiovascular and renal) similar to the all-comparators group treated with other T2DM medications or placebo. Albiglutide treatment was associated with higher rates of diarrhoea and injection-site reactions, but not increased nausea and vomiting, versus all comparators. CI - Copyright (c) 2017 Elsevier B.V. All rights reserved. FAU - Ahren, Bo AU - Ahren B AD - Department of Clinical Services Division of Medicine, Lund University, Lund, Sweden. Electronic address: Bo.Ahren@med.lu.se. FAU - Carr, Molly C AU - Carr MC AD - Pharma Research & Development, GlaxoSmithKline, Collegeville, PA, USA. Electronic address: molly.c.carr@gsk.com. FAU - Murphy, Karen AU - Murphy K AD - Pharma Research & Development, GlaxoSmithKline, Collegeville, PA, USA. Electronic address: Karen.J.Murphy@gsk.com. FAU - Perkins, Christopher AU - Perkins C AD - PPD, Inc, Morrisville, NC, USA. Electronic address: christopher.perkins@ppdi.com. FAU - Rendell, Marc AU - Rendell M AD - Department of Medicine, Division of Endocrinology, Creighton University, Omaha, NE, USA. Electronic address: rendell@asndi.com. FAU - Mallory, Jason AU - Mallory J AD - Pharma Research & Development, GlaxoSmithKline, Upper Merion, PA, USA. Electronic address: jasonmallory@hotmail.com. FAU - Wilson, Timothy AU - Wilson T AD - Pharma Research & Development, R&D Projects Clinical Platforms, PCPS Qsci Clinical Statistics, Research Triangle Park, Durham, NC, USA. Electronic address: Tim.Wilson@parexel.com. FAU - Johnson, Susan AU - Johnson S AD - Pharma Research & Development, GlaxoSmithKline, Upper Merion, PA, USA. Electronic address: Susan.l.johnon@pfizer.com. LA - eng PT - Clinical Trial, Phase II PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20170220 PL - Ireland TA - Diabetes Res Clin Pract JT - Diabetes research and clinical practice JID - 8508335 RN - 0 (Blood Glucose) RN - 0 (Dipeptidyl-Peptidase IV Inhibitors) RN - 0 (Glucagon-Like Peptide-1 Receptor) RN - 0 (Hypoglycemic Agents) RN - 0 (Incretins) RN - 0 (Insulin) RN - 0 (Sulfonylurea Compounds) RN - 5E7U48495E (rGLP-1 protein) RN - 89750-14-1 (Glucagon-Like Peptide 1) SB - IM MH - Adult MH - Aged MH - Blood Glucose/drug effects/metabolism MH - Diabetes Mellitus, Type 2/blood/*drug therapy MH - Dipeptidyl-Peptidase IV Inhibitors/therapeutic use MH - Drug Therapy, Combination MH - Drug-Related Side Effects and Adverse Reactions/epidemiology/*etiology MH - Female MH - Glucagon-Like Peptide 1/adverse effects/*analogs & derivatives/therapeutic use MH - Glucagon-Like Peptide-1 Receptor MH - Humans MH - Hypoglycemia/chemically induced/epidemiology MH - Hypoglycemic Agents/adverse effects/*therapeutic use MH - Incretins/therapeutic use MH - Injections/adverse effects MH - Insulin/therapeutic use MH - Male MH - Middle Aged MH - Sulfonylurea Compounds/therapeutic use OTO - NOTNLM OT - Diabetes mellitus OT - Glucagon-like peptide-1 OT - Incretins OT - Long-term safety EDAT- 2017/03/12 06:00 MHDA- 2017/06/27 06:00 CRDT- 2017/03/12 06:00 PHST- 2016/10/19 00:00 [received] PHST- 2017/01/17 00:00 [revised] PHST- 2017/02/13 00:00 [accepted] PHST- 2017/03/12 06:00 [pubmed] PHST- 2017/06/27 06:00 [medline] PHST- 2017/03/12 06:00 [entrez] AID - S0168-8227(16)30730-6 [pii] AID - 10.1016/j.diabres.2017.02.017 [doi] PST - ppublish SO - Diabetes Res Clin Pract. 2017 Apr;126:230-239. doi: 10.1016/j.diabres.2017.02.017. Epub 2017 Feb 20.