Once-weekly administration of dulaglutide, a glucagon-like peptide-1 receptor agonist, as monotherapy and combination therapy: review of the AWARD studies

For the purpose of exploring the development, pharmacology and clinical trial program related to dulaglutide, we conducted a nonsystematic review of dulaglutide, focusing on the AWARD (Assessment of Weekly Administration of LY2189265 [dulaglutide] in Diabetes Assessment) program of randomized, phase...

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Autores principales:	Marina V. Shestakova, Ekaterina A. Yudovich
Formato:	article
Lenguaje:	EN RU
Publicado:	Endocrinology Research Centre 2017
Materias:	diabetes mellitus type 2, dulaglutide, glucagon-like peptide 1, hypoglycemic agents Nutritional diseases. Deficiency diseases RC620-627
Acceso en línea:	https://doaj.org/article/920261f7ddfc46f8917fdab419d3f48b
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spelling	oai:doaj.org-article:920261f7ddfc46f8917fdab419d3f48b2021-11-14T09:00:21ZOnce-weekly administration of dulaglutide, a glucagon-like peptide-1 receptor agonist, as monotherapy and combination therapy: review of the AWARD studies2072-03512072-037810.14341/DM20151S1-112https://doaj.org/article/920261f7ddfc46f8917fdab419d3f48b2017-08-01T00:00:00Zhttps://www.dia-endojournals.ru/jour/article/view/8347https://doaj.org/toc/2072-0351https://doaj.org/toc/2072-0378For the purpose of exploring the development, pharmacology and clinical trial program related to dulaglutide, we conducted a nonsystematic review of dulaglutide, focusing on the AWARD (Assessment of Weekly Administration of LY2189265 [dulaglutide] in Diabetes Assessment) program of randomized, phase 3 studies. Dulaglutide is a glucagon-like peptide 1 (GLP-1) receptor agonist that causes a variety of antidiabetogenic actions by acting on the incretin system. Steady-state plasma concentrations of dulaglutide are achieved between 2 and 4 weeks following a once-weekly administration. The AWARD 1–6 studies were conducted in patients with different treatment needs, ranging from patients with mild diabetes who can be treated with diet management and exercise to patients for whom target glycemic control cannot be achieved with conventional insulin treatment. Changes in HbA1c from baseline to the primary endpoint assessment (primary efficacy outcome) with dulaglutide were generally dose-dependent and significantly greater than those of active comparators and placebos (AWARD 1–5) or non-inferior to the comparators (AWARD 6). The results of secondary outcome measures demonstrated that glycemic control attained with dulaglutide was sustained for long-term and that a greater proportion of patients treated with dulaglutide achieved a target HbA1c level of <7.0% compared with placebo and/or active comparators. Reduction in fasting serum glucose, glucagon levels and body weight after dulaglutide treatment were noted in most AWARD studies. Although treatment-emergent adverse events were common with dulaglutide, the incidence was similar to that of active comparators in most AWARD studies, and serious adverse events were generally infrequent, except in patients with more severe disease or with prolonged therapy. Hypoglycemic and immunogenic events were also infrequent. In patients with type 2 diabetes, dulaglutide improves glycemic control and leads to clinically useful reduction in body weight in a range of treatment settings.Marina V. ShestakovaEkaterina A. YudovichEndocrinology Research Centrearticlediabetes mellitus type 2, dulaglutide, glucagon-like peptide 1, hypoglycemic agentsNutritional diseases. Deficiency diseasesRC620-627ENRUСахарный диабет, Vol 20, Iss 3, Pp 220-230 (2017)
institution	DOAJ
collection	DOAJ
language	EN RU
topic	diabetes mellitus type 2, dulaglutide, glucagon-like peptide 1, hypoglycemic agents Nutritional diseases. Deficiency diseases RC620-627
spellingShingle	diabetes mellitus type 2, dulaglutide, glucagon-like peptide 1, hypoglycemic agents Nutritional diseases. Deficiency diseases RC620-627 Marina V. Shestakova Ekaterina A. Yudovich Once-weekly administration of dulaglutide, a glucagon-like peptide-1 receptor agonist, as monotherapy and combination therapy: review of the AWARD studies
description	For the purpose of exploring the development, pharmacology and clinical trial program related to dulaglutide, we conducted a nonsystematic review of dulaglutide, focusing on the AWARD (Assessment of Weekly Administration of LY2189265 [dulaglutide] in Diabetes Assessment) program of randomized, phase 3 studies. Dulaglutide is a glucagon-like peptide 1 (GLP-1) receptor agonist that causes a variety of antidiabetogenic actions by acting on the incretin system. Steady-state plasma concentrations of dulaglutide are achieved between 2 and 4 weeks following a once-weekly administration. The AWARD 1–6 studies were conducted in patients with different treatment needs, ranging from patients with mild diabetes who can be treated with diet management and exercise to patients for whom target glycemic control cannot be achieved with conventional insulin treatment. Changes in HbA1c from baseline to the primary endpoint assessment (primary efficacy outcome) with dulaglutide were generally dose-dependent and significantly greater than those of active comparators and placebos (AWARD 1–5) or non-inferior to the comparators (AWARD 6). The results of secondary outcome measures demonstrated that glycemic control attained with dulaglutide was sustained for long-term and that a greater proportion of patients treated with dulaglutide achieved a target HbA1c level of <7.0% compared with placebo and/or active comparators. Reduction in fasting serum glucose, glucagon levels and body weight after dulaglutide treatment were noted in most AWARD studies. Although treatment-emergent adverse events were common with dulaglutide, the incidence was similar to that of active comparators in most AWARD studies, and serious adverse events were generally infrequent, except in patients with more severe disease or with prolonged therapy. Hypoglycemic and immunogenic events were also infrequent. In patients with type 2 diabetes, dulaglutide improves glycemic control and leads to clinically useful reduction in body weight in a range of treatment settings.
format	article
author	Marina V. Shestakova Ekaterina A. Yudovich
author_facet	Marina V. Shestakova Ekaterina A. Yudovich
author_sort	Marina V. Shestakova
title	Once-weekly administration of dulaglutide, a glucagon-like peptide-1 receptor agonist, as monotherapy and combination therapy: review of the AWARD studies
title_short	Once-weekly administration of dulaglutide, a glucagon-like peptide-1 receptor agonist, as monotherapy and combination therapy: review of the AWARD studies
title_full	Once-weekly administration of dulaglutide, a glucagon-like peptide-1 receptor agonist, as monotherapy and combination therapy: review of the AWARD studies
title_fullStr	Once-weekly administration of dulaglutide, a glucagon-like peptide-1 receptor agonist, as monotherapy and combination therapy: review of the AWARD studies
title_full_unstemmed	Once-weekly administration of dulaglutide, a glucagon-like peptide-1 receptor agonist, as monotherapy and combination therapy: review of the AWARD studies
title_sort	once-weekly administration of dulaglutide, a glucagon-like peptide-1 receptor agonist, as monotherapy and combination therapy: review of the award studies
publisher	Endocrinology Research Centre
publishDate	2017
url	https://doaj.org/article/920261f7ddfc46f8917fdab419d3f48b
work_keys_str_mv	AT marinavshestakova onceweeklyadministrationofdulaglutideaglucagonlikepeptide1receptoragonistasmonotherapyandcombinationtherapyreviewoftheawardstudies AT ekaterinaayudovich onceweeklyadministrationofdulaglutideaglucagonlikepeptide1receptoragonistasmonotherapyandcombinationtherapyreviewoftheawardstudies
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Once-weekly administration of dulaglutide, a glucagon-like peptide-1 receptor agonist, as monotherapy and combination therapy: review of the AWARD studies

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