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Three-year data from 5 HARMONY phase 3 clinical trials of albiglutide in type 2 diabetes mellitus : Long-term efficacy with or without rescue therapy

Home, Philip D.; Ahrén, Bo LU ; Reusch, Jane E.B.; Rendell, Marc; Weissman, Peter N.; Cirkel, Deborah T; Miller, Diane; Ambery, Philip; Carr, Molly C. and Nauck, Michael A. (2017) In Diabetes Research and Clinical Practice 131. p.49-60
Abstract

Aims Diabetes therapies that provide durable glycaemic control for people with type 2 diabetes mellitus (T2DM) are needed. We present efficacy results of albiglutide, a glucagon-like peptide-1 receptor agonist, in people with T2DM over a 3-year period. Methods Five of the 8 HARMONY phase 3 trials, comparing albiglutide with other therapies or placebo across a spectrum of clinical care, lasted for a preplanned 3 years. Participants with uncontrolled hyperglycaemia who met predetermined criteria could receive rescue medication. The ability to remain on study medication without needing additional rescue was an efficacy measure. Glycaemic measures and body weight were analysed in 2 populations: those who remained rescue-free and all... (More)

Aims Diabetes therapies that provide durable glycaemic control for people with type 2 diabetes mellitus (T2DM) are needed. We present efficacy results of albiglutide, a glucagon-like peptide-1 receptor agonist, in people with T2DM over a 3-year period. Methods Five of the 8 HARMONY phase 3 trials, comparing albiglutide with other therapies or placebo across a spectrum of clinical care, lasted for a preplanned 3 years. Participants with uncontrolled hyperglycaemia who met predetermined criteria could receive rescue medication. The ability to remain on study medication without needing additional rescue was an efficacy measure. Glycaemic measures and body weight were analysed in 2 populations: those who remained rescue-free and all participants. Results Participants (n = 3132) were randomised to albiglutide or comparator. A greater proportion of participants who received albiglutide remained rescue-free (55–71%) compared with placebo (35–51%; p < 0.001 to p = 0.002). The proportion of rescue-free participants with albiglutide did not differ from glimepiride or insulin glargine, was higher than with sitagliptin (p = 0.013), and lower than with pioglitazone (p = 0.045). At 3 years, albiglutide was associated with clinically significant reductions in hyperglycaemia (eg, rescue-free participants: HbA1c −0.52% [SE0.11] to −0.98% [0.12]; −5.7 mmol/mol [1.2] to −10.7 mmol/mol [1.3] and all participants: HbA1c −0.29% [0.11] to − 0.92% [0.13]; −3.2 mmol/mol [1.2] to −10.1 mmol/mol [1.4]). Albiglutide was also associated with modest reductions in body weight vs pioglitazone, glimepiride, and insulin glargine, which were associated with weight gain. Conclusion These 3-year efficacy data support long-term use of albiglutide in the management of people with T2DM. ClinicalTrials.gov NCT00849056, NCT00849017, NCT00838903, NCT00838916, NCT00839527.

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organization
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type
Contribution to journal
publication status
published
subject
keywords
Albiglutide, Diabetes mellitus, Durability, Efficacy, Glucagon-like peptide-1, Incretins
in
Diabetes Research and Clinical Practice
volume
131
pages
12 pages
publisher
Elsevier
external identifiers
  • scopus:85021422439
ISSN
0168-8227
DOI
10.1016/j.diabres.2017.06.013
language
English
LU publication?
yes
id
5df68ddb-09dc-42a5-8e02-cb1f9c8dbbca
date added to LUP
2017-07-26 14:21:18
date last changed
2017-07-31 10:32:33
@article{5df68ddb-09dc-42a5-8e02-cb1f9c8dbbca,
  abstract     = {<p>Aims Diabetes therapies that provide durable glycaemic control for people with type 2 diabetes mellitus (T2DM) are needed. We present efficacy results of albiglutide, a glucagon-like peptide-1 receptor agonist, in people with T2DM over a 3-year period. Methods Five of the 8 HARMONY phase 3 trials, comparing albiglutide with other therapies or placebo across a spectrum of clinical care, lasted for a preplanned 3 years. Participants with uncontrolled hyperglycaemia who met predetermined criteria could receive rescue medication. The ability to remain on study medication without needing additional rescue was an efficacy measure. Glycaemic measures and body weight were analysed in 2 populations: those who remained rescue-free and all participants. Results Participants (n = 3132) were randomised to albiglutide or comparator. A greater proportion of participants who received albiglutide remained rescue-free (55–71%) compared with placebo (35–51%; p &lt; 0.001 to p = 0.002). The proportion of rescue-free participants with albiglutide did not differ from glimepiride or insulin glargine, was higher than with sitagliptin (p = 0.013), and lower than with pioglitazone (p = 0.045). At 3 years, albiglutide was associated with clinically significant reductions in hyperglycaemia (eg, rescue-free participants: HbA1c −0.52% [SE0.11] to −0.98% [0.12]; −5.7 mmol/mol [1.2] to −10.7 mmol/mol [1.3] and all participants: HbA1c −0.29% [0.11] to − 0.92% [0.13]; −3.2 mmol/mol [1.2] to −10.1 mmol/mol [1.4]). Albiglutide was also associated with modest reductions in body weight vs pioglitazone, glimepiride, and insulin glargine, which were associated with weight gain. Conclusion These 3-year efficacy data support long-term use of albiglutide in the management of people with T2DM. ClinicalTrials.gov NCT00849056, NCT00849017, NCT00838903, NCT00838916, NCT00839527.</p>},
  author       = {Home, Philip D. and Ahrén, Bo and Reusch, Jane E.B. and Rendell, Marc and Weissman, Peter N. and Cirkel, Deborah T and Miller, Diane and Ambery, Philip and Carr, Molly C. and Nauck, Michael A.},
  issn         = {0168-8227},
  keyword      = {Albiglutide,Diabetes mellitus,Durability,Efficacy,Glucagon-like peptide-1,Incretins},
  language     = {eng},
  month        = {09},
  pages        = {49--60},
  publisher    = {Elsevier},
  series       = {Diabetes Research and Clinical Practice},
  title        = {Three-year data from 5 HARMONY phase 3 clinical trials of albiglutide in type 2 diabetes mellitus : Long-term efficacy with or without rescue therapy},
  url          = {http://dx.doi.org/10.1016/j.diabres.2017.06.013},
  volume       = {131},
  year         = {2017},
}