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

Bo Ahrén, Molly C. Carr, Karen Murphy, Christopher Perkins, Marc Rendell, Jason Mallory, Timothy Wilson, Susan Johnson

Research output: Contribution to journalArticle

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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. 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.

Original languageEnglish (US)
Pages (from-to)230-239
Number of pages10
JournalDiabetes Research and Clinical Practice
Volume126
DOIs
StatePublished - Apr 1 2017

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Type 2 Diabetes Mellitus
Safety
Therapeutics
Nausea
Vomiting
Diarrhea
Medical Dictionaries
Placebos
Dipeptidyl-Peptidase IV Inhibitors
Incretins
Kidney
Phase III Clinical Trials
Injections
rGLP-1 protein
Hypoglycemia
Pancreatitis
Edema
Insulin
Glucagon-Like Peptide-1 Receptor

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Albiglutide for the treatment of type 2 diabetes mellitus : An integrated safety analysis of the HARMONY phase 3 trials. / Ahrén, Bo; Carr, Molly C.; Murphy, Karen; Perkins, Christopher; Rendell, Marc; Mallory, Jason; Wilson, Timothy; Johnson, Susan.

In: Diabetes Research and Clinical Practice, Vol. 126, 01.04.2017, p. 230-239.

Research output: Contribution to journalArticle

Ahrén, Bo ; Carr, Molly C. ; Murphy, Karen ; Perkins, Christopher ; Rendell, Marc ; Mallory, Jason ; Wilson, Timothy ; Johnson, Susan. / Albiglutide for the treatment of type 2 diabetes mellitus : An integrated safety analysis of the HARMONY phase 3 trials. In: Diabetes Research and Clinical Practice. 2017 ; Vol. 126. pp. 230-239.
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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. 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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T2 - An integrated safety analysis of the HARMONY phase 3 trials

AU - Ahrén, Bo

AU - Carr, Molly C.

AU - Murphy, Karen

AU - Perkins, Christopher

AU - Rendell, Marc

AU - Mallory, Jason

AU - Wilson, Timothy

AU - Johnson, Susan

PY - 2017/4/1

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N2 - 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.

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 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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