Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Araki, E., Inagaki, N., Tanizawa, Y., Oura, T., Takeuchi, M., Imaoka, T.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Blackwell Publishing Ltd 2015
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
_version_ 1782456545183793152
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
work_keys_str_mv AT arakie efficacyandsafetyofonceweeklydulaglutideincombinationwithsulphonylureaandorbiguanidecomparedwithoncedailyinsulinglargineinjapanesepatientswithtype2diabetesarandomizedopenlabelphaseiiinoninferioritystudy
AT inagakin efficacyandsafetyofonceweeklydulaglutideincombinationwithsulphonylureaandorbiguanidecomparedwithoncedailyinsulinglargineinjapanesepatientswithtype2diabetesarandomizedopenlabelphaseiiinoninferioritystudy
AT tanizaway efficacyandsafetyofonceweeklydulaglutideincombinationwithsulphonylureaandorbiguanidecomparedwithoncedailyinsulinglargineinjapanesepatientswithtype2diabetesarandomizedopenlabelphaseiiinoninferioritystudy
AT ourat efficacyandsafetyofonceweeklydulaglutideincombinationwithsulphonylureaandorbiguanidecomparedwithoncedailyinsulinglargineinjapanesepatientswithtype2diabetesarandomizedopenlabelphaseiiinoninferioritystudy
AT takeuchim efficacyandsafetyofonceweeklydulaglutideincombinationwithsulphonylureaandorbiguanidecomparedwithoncedailyinsulinglargineinjapanesepatientswithtype2diabetesarandomizedopenlabelphaseiiinoninferioritystudy
AT imaokat efficacyandsafetyofonceweeklydulaglutideincombinationwithsulphonylureaandorbiguanidecomparedwithoncedailyinsulinglargineinjapanesepatientswithtype2diabetesarandomizedopenlabelphaseiiinoninferioritystudy