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Safety and efficacy of once‐weekly dulaglutide versus sitagliptin after 2 years in metformin‐treated patients with type 2 diabetes (AWARD‐5): a randomized, phase III study
AIMS: To compare the once‐weekly glucagon‐like peptide‐1 (GLP‐1) receptor dulaglutide with the dipeptidyl peptidase‐4 (DPP‐4) inhibitor sitagliptin after 104 weeks of treatment. METHODS: This AWARD‐5 study was a multicentre, double‐blind trial that randomized participants to dulaglutide (1.5 or 0.75...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Blackwell Publishing Ltd
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5008205/ https://www.ncbi.nlm.nih.gov/pubmed/25912221 http://dx.doi.org/10.1111/dom.12479 |
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author | Weinstock, R. S. Guerci, B. Umpierrez, G. Nauck, M. A. Skrivanek, Z. Milicevic, Z. |
author_facet | Weinstock, R. S. Guerci, B. Umpierrez, G. Nauck, M. A. Skrivanek, Z. Milicevic, Z. |
author_sort | Weinstock, R. S. |
collection | PubMed |
description | AIMS: To compare the once‐weekly glucagon‐like peptide‐1 (GLP‐1) receptor dulaglutide with the dipeptidyl peptidase‐4 (DPP‐4) inhibitor sitagliptin after 104 weeks of treatment. METHODS: This AWARD‐5 study was a multicentre, double‐blind trial that randomized participants to dulaglutide (1.5 or 0.75 mg) or sitagliptin 100 mg for 104 weeks or placebo (reported separately) for 26 weeks. Change in glycated haemoglobin (HbA1c) concentration from baseline was the primary efficacy measure. A total of 1098 participants with HbA1c concentrations ≥7.0% (≥53.0 mmol/mol) and ≤9.5% (≤80.3 mmol/mol) were randomized, and 657 (59.8%) completed the study. We report results for dulaglutide and sitagliptin at the final endpoint. RESULTS: Changes in HbA1c at 104 weeks were (least squares mean ± standard error) −0.99 ± 0.06% (−10.82 ± 0.66 mmol/mol), −0.71 ± 0.07% (−7.76 ± 0.77 mmol/mol) and −0.32 ± 0.06% (−3.50 ± 0.66 mmol/mol) for dulaglutide 1.5 mg, dulaglutide 0.75 mg and sitagliptin, respectively (p < 0.001, both dulaglutide doses vs sitagliptin). Weight loss was greater with dulaglutide 1.5 mg (p < 0.001) and similar with 0.75 mg versus sitagliptin (2.88 ± 0.25, 2.39 ± 0.26 and 1.75 ± 0.25 kg, respectively). Gastrointestinal adverse events were more common with dulaglutide 1.5 and 0.75 mg versus sitagliptin (nausea 17 and 15% vs 7%, diarrhoea 16 and 12% vs 6%, vomiting 14 and 8% vs 4% respectively). Pancreatic, thyroid, cardiovascular and hypersensitivity safety were similar across groups. CONCLUSIONS: Dulaglutide doses provided superior glycaemic control and dulaglutide 1.5 mg resulted in greater weight reduction versus sitagliptin at 104 weeks, with acceptable safety. |
format | Online Article Text |
id | pubmed-5008205 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Blackwell Publishing Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-50082052016-09-16 Safety and efficacy of once‐weekly dulaglutide versus sitagliptin after 2 years in metformin‐treated patients with type 2 diabetes (AWARD‐5): a randomized, phase III study Weinstock, R. S. Guerci, B. Umpierrez, G. Nauck, M. A. Skrivanek, Z. Milicevic, Z. Diabetes Obes Metab Original Articles AIMS: To compare the once‐weekly glucagon‐like peptide‐1 (GLP‐1) receptor dulaglutide with the dipeptidyl peptidase‐4 (DPP‐4) inhibitor sitagliptin after 104 weeks of treatment. METHODS: This AWARD‐5 study was a multicentre, double‐blind trial that randomized participants to dulaglutide (1.5 or 0.75 mg) or sitagliptin 100 mg for 104 weeks or placebo (reported separately) for 26 weeks. Change in glycated haemoglobin (HbA1c) concentration from baseline was the primary efficacy measure. A total of 1098 participants with HbA1c concentrations ≥7.0% (≥53.0 mmol/mol) and ≤9.5% (≤80.3 mmol/mol) were randomized, and 657 (59.8%) completed the study. We report results for dulaglutide and sitagliptin at the final endpoint. RESULTS: Changes in HbA1c at 104 weeks were (least squares mean ± standard error) −0.99 ± 0.06% (−10.82 ± 0.66 mmol/mol), −0.71 ± 0.07% (−7.76 ± 0.77 mmol/mol) and −0.32 ± 0.06% (−3.50 ± 0.66 mmol/mol) for dulaglutide 1.5 mg, dulaglutide 0.75 mg and sitagliptin, respectively (p < 0.001, both dulaglutide doses vs sitagliptin). Weight loss was greater with dulaglutide 1.5 mg (p < 0.001) and similar with 0.75 mg versus sitagliptin (2.88 ± 0.25, 2.39 ± 0.26 and 1.75 ± 0.25 kg, respectively). Gastrointestinal adverse events were more common with dulaglutide 1.5 and 0.75 mg versus sitagliptin (nausea 17 and 15% vs 7%, diarrhoea 16 and 12% vs 6%, vomiting 14 and 8% vs 4% respectively). Pancreatic, thyroid, cardiovascular and hypersensitivity safety were similar across groups. CONCLUSIONS: Dulaglutide doses provided superior glycaemic control and dulaglutide 1.5 mg resulted in greater weight reduction versus sitagliptin at 104 weeks, with acceptable safety. Blackwell Publishing Ltd 2015-05-20 2015-09 /pmc/articles/PMC5008205/ /pubmed/25912221 http://dx.doi.org/10.1111/dom.12479 Text en © 2015 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Original Articles Weinstock, R. S. Guerci, B. Umpierrez, G. Nauck, M. A. Skrivanek, Z. Milicevic, Z. Safety and efficacy of once‐weekly dulaglutide versus sitagliptin after 2 years in metformin‐treated patients with type 2 diabetes (AWARD‐5): a randomized, phase III study |
title | Safety and efficacy of once‐weekly dulaglutide versus sitagliptin after 2 years in metformin‐treated patients with type 2 diabetes (AWARD‐5): a randomized, phase III study |
title_full | Safety and efficacy of once‐weekly dulaglutide versus sitagliptin after 2 years in metformin‐treated patients with type 2 diabetes (AWARD‐5): a randomized, phase III study |
title_fullStr | Safety and efficacy of once‐weekly dulaglutide versus sitagliptin after 2 years in metformin‐treated patients with type 2 diabetes (AWARD‐5): a randomized, phase III study |
title_full_unstemmed | Safety and efficacy of once‐weekly dulaglutide versus sitagliptin after 2 years in metformin‐treated patients with type 2 diabetes (AWARD‐5): a randomized, phase III study |
title_short | Safety and efficacy of once‐weekly dulaglutide versus sitagliptin after 2 years in metformin‐treated patients with type 2 diabetes (AWARD‐5): a randomized, phase III study |
title_sort | safety and efficacy of once‐weekly dulaglutide versus sitagliptin after 2 years in metformin‐treated patients with type 2 diabetes (award‐5): a randomized, phase iii study |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5008205/ https://www.ncbi.nlm.nih.gov/pubmed/25912221 http://dx.doi.org/10.1111/dom.12479 |
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