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Albiglutide for the treatment of type 2 diabetes mellitus : An integrated safety analysis of the HARMONY phase 3 trials

Ahrén, Bo LU ; Carr, Molly C.; Murphy, Karen; Perkins, Christopher; Rendell, Marc; Mallory, Jason; Wilson, Timothy and Johnson, Susan L (2017) In Diabetes Research and Clinical Practice 126. p.230-239
Abstract

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 3 years 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 32 months (HARMONY 7), 1 year (HARMONY 6), and 3 years (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.... (More)

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 3 years 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 32 months (HARMONY 7), 1 year (HARMONY 6), and 3 years (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.

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author
organization
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type
Contribution to journal
publication status
published
subject
keywords
Diabetes mellitus, Glucagon-like peptide-1, Incretins, Long-term safety
in
Diabetes Research and Clinical Practice
volume
126
pages
10 pages
publisher
Elsevier
external identifiers
  • scopus:85014643177
  • wos:000402467800029
ISSN
0168-8227
DOI
10.1016/j.diabres.2017.02.017
language
English
LU publication?
yes
id
b36ec632-ccf9-4739-9329-67c6e675fb76
date added to LUP
2017-04-03 09:49:37
date last changed
2018-01-07 11:57:43
@article{b36ec632-ccf9-4739-9329-67c6e675fb76,
  abstract     = {<p>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 3 years 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 32 months (HARMONY 7), 1 year (HARMONY 6), and 3 years (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.</p>},
  author       = {Ahrén, Bo and Carr, Molly C. and Murphy, Karen and Perkins, Christopher and Rendell, Marc and Mallory, Jason and Wilson, Timothy and Johnson, Susan L},
  issn         = {0168-8227},
  keyword      = {Diabetes mellitus,Glucagon-like peptide-1,Incretins,Long-term safety},
  language     = {eng},
  pages        = {230--239},
  publisher    = {Elsevier},
  series       = {Diabetes Research and Clinical Practice},
  title        = {Albiglutide for the treatment of type 2 diabetes mellitus : An integrated safety analysis of the HARMONY phase 3 trials},
  url          = {http://dx.doi.org/10.1016/j.diabres.2017.02.017},
  volume       = {126},
  year         = {2017},
}