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Efficacy and safety of once‐weekly dulaglutide in combination with sulphonylurea and/or biguanide compared with once‐daily insulin glargine in Japanese patients with type 2 diabetes: a randomized, open‐label, phase III, non‐inferiority study
AIMS: To evaluate 0.75 mg of dulaglutide, a once‐weekly glucagon‐like peptide‐1 receptor agonist, compared with once‐daily insulin glargine for glycaemic control in Japanese patients with type 2 diabetes (T2D). METHODS: In this phase III, randomized, open‐label, parallel‐group, 26‐week study, 361 pa...
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/PMC5042081/ https://www.ncbi.nlm.nih.gov/pubmed/26179754 http://dx.doi.org/10.1111/dom.12540 |
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author | Araki, E. Inagaki, N. Tanizawa, Y. Oura, T. Takeuchi, M. Imaoka, T. |
author_facet | Araki, E. Inagaki, N. Tanizawa, Y. Oura, T. Takeuchi, M. Imaoka, T. |
author_sort | Araki, E. |
collection | PubMed |
description | AIMS: To evaluate 0.75 mg of dulaglutide, a once‐weekly glucagon‐like peptide‐1 receptor agonist, compared with once‐daily insulin glargine for glycaemic control in Japanese patients with type 2 diabetes (T2D). METHODS: In this phase III, randomized, open‐label, parallel‐group, 26‐week study, 361 patients with inadequately controlled T2D receiving sulphonylureas and/or biguanides, aged ≥20 years, with glycated haemoglobin (HbA1c) levels 7.0–10.0% (53–86 mmol/mol), inclusive, were randomized (1 : 1) to receive dulaglutide or glargine. Participants and investigators were not masked to treatment allocation. The primary measure was change from baseline in HbA1c at 26 weeks, analysed using a mixed‐effects model for repeated measures, with a predefined non‐inferiority margin of 0.4%. RESULTS: At week 26, least‐squares (LS) mean (standard error) reductions in HbA1c were −1.44 (0.05)% [−15.74 (0.55) mmol/mol] in the dulaglutide group and −0.90 (0.05)% [−9.84 (0.55) mmol/mol] in the glargine group. The mean between‐group treatment difference in HbA1c was −0.54% (95% CI −0.67, −0.41) [−5.90 mmol/mol (95% CI −7.32, −4.48)]; p < 0.001. Dulaglutide significantly reduced body weight compared with glargine at week 26 (LS mean difference −1.42 kg, 95% CI −1.89, −0.94; p < 0.001). The most frequent adverse events with dulaglutide treatment were nasopharyngitis and gastrointestinal symptoms. The incidence of hypoglycaemia was significantly lower with dulaglutide [47/181 (26%)] compared with glargine [86/180 (48%)], p < 0.001. CONCLUSION: In Japanese patients with T2D uncontrolled on sulphonylureas and/or biguanides, once‐weekly dulaglutide was superior to once‐daily glargine for reduction in HbA1c at 26 weeks. Although dulaglutide increased gastrointestinal symptoms, it was well tolerated, with an acceptable safety profile. |
format | Online Article Text |
id | pubmed-5042081 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Blackwell Publishing Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-50420812016-10-03 Efficacy and safety of once‐weekly dulaglutide in combination with sulphonylurea and/or biguanide compared with once‐daily insulin glargine in Japanese patients with type 2 diabetes: a randomized, open‐label, phase III, non‐inferiority study Araki, E. Inagaki, N. Tanizawa, Y. Oura, T. Takeuchi, M. Imaoka, T. Diabetes Obes Metab Original Articles AIMS: To evaluate 0.75 mg of dulaglutide, a once‐weekly glucagon‐like peptide‐1 receptor agonist, compared with once‐daily insulin glargine for glycaemic control in Japanese patients with type 2 diabetes (T2D). METHODS: In this phase III, randomized, open‐label, parallel‐group, 26‐week study, 361 patients with inadequately controlled T2D receiving sulphonylureas and/or biguanides, aged ≥20 years, with glycated haemoglobin (HbA1c) levels 7.0–10.0% (53–86 mmol/mol), inclusive, were randomized (1 : 1) to receive dulaglutide or glargine. Participants and investigators were not masked to treatment allocation. The primary measure was change from baseline in HbA1c at 26 weeks, analysed using a mixed‐effects model for repeated measures, with a predefined non‐inferiority margin of 0.4%. RESULTS: At week 26, least‐squares (LS) mean (standard error) reductions in HbA1c were −1.44 (0.05)% [−15.74 (0.55) mmol/mol] in the dulaglutide group and −0.90 (0.05)% [−9.84 (0.55) mmol/mol] in the glargine group. The mean between‐group treatment difference in HbA1c was −0.54% (95% CI −0.67, −0.41) [−5.90 mmol/mol (95% CI −7.32, −4.48)]; p < 0.001. Dulaglutide significantly reduced body weight compared with glargine at week 26 (LS mean difference −1.42 kg, 95% CI −1.89, −0.94; p < 0.001). The most frequent adverse events with dulaglutide treatment were nasopharyngitis and gastrointestinal symptoms. The incidence of hypoglycaemia was significantly lower with dulaglutide [47/181 (26%)] compared with glargine [86/180 (48%)], p < 0.001. CONCLUSION: In Japanese patients with T2D uncontrolled on sulphonylureas and/or biguanides, once‐weekly dulaglutide was superior to once‐daily glargine for reduction in HbA1c at 26 weeks. Although dulaglutide increased gastrointestinal symptoms, it was well tolerated, with an acceptable safety profile. Blackwell Publishing Ltd 2015-08-20 2015-10 /pmc/articles/PMC5042081/ /pubmed/26179754 http://dx.doi.org/10.1111/dom.12540 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 (http://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Original Articles Araki, E. Inagaki, N. Tanizawa, Y. Oura, T. Takeuchi, M. Imaoka, T. Efficacy and safety of once‐weekly dulaglutide in combination with sulphonylurea and/or biguanide compared with once‐daily insulin glargine in Japanese patients with type 2 diabetes: a randomized, open‐label, phase III, non‐inferiority study |
title | Efficacy and safety of once‐weekly dulaglutide in combination with sulphonylurea and/or biguanide compared with once‐daily insulin glargine in Japanese patients with type 2 diabetes: a randomized, open‐label, phase III, non‐inferiority study |
title_full | Efficacy and safety of once‐weekly dulaglutide in combination with sulphonylurea and/or biguanide compared with once‐daily insulin glargine in Japanese patients with type 2 diabetes: a randomized, open‐label, phase III, non‐inferiority study |
title_fullStr | Efficacy and safety of once‐weekly dulaglutide in combination with sulphonylurea and/or biguanide compared with once‐daily insulin glargine in Japanese patients with type 2 diabetes: a randomized, open‐label, phase III, non‐inferiority study |
title_full_unstemmed | Efficacy and safety of once‐weekly dulaglutide in combination with sulphonylurea and/or biguanide compared with once‐daily insulin glargine in Japanese patients with type 2 diabetes: a randomized, open‐label, phase III, non‐inferiority study |
title_short | Efficacy and safety of once‐weekly dulaglutide in combination with sulphonylurea and/or biguanide compared with once‐daily insulin glargine in Japanese patients with type 2 diabetes: a randomized, open‐label, phase III, non‐inferiority study |
title_sort | efficacy and safety of once‐weekly dulaglutide in combination with sulphonylurea and/or biguanide compared with once‐daily insulin glargine in japanese patients with type 2 diabetes: a randomized, open‐label, phase iii, non‐inferiority study |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5042081/ https://www.ncbi.nlm.nih.gov/pubmed/26179754 http://dx.doi.org/10.1111/dom.12540 |
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