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Efficacy and safety of a basal insulin + 2‐3 oral antihyperglycaemic drugs regimen versus a twice‐daily premixed insulin + metformin regimen after short‐term intensive insulin therapy in individuals with type 2 diabetes: The multicentre, open‐label, randomized controlled BEYOND‐V trial
AIM: To compare the efficacy and safety of basal insulin glargine 100 units/ml (Gla) + 2‐3 oral antihyperglycaemic drugs (OADs) with twice‐daily premixed insulin aspart 70/30 (Asp30) + metformin (MET) after short‐term intensive insulin therapy in adults with type 2 diabetes in China. MATERIALS AND M...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Blackwell Publishing Ltd
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9543477/ https://www.ncbi.nlm.nih.gov/pubmed/35642463 http://dx.doi.org/10.1111/dom.14780 |
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author | Pan, Qi Li, Yijun Wan, Hailong Wang, Junfen Xu, Binhua Wang, Guoping Jiang, Chengxia Liang, Li Feng, Wei Liu, Jingcheng Wang, Ting Zhang, Xia Cui, Nan Mu, Yiming Guo, Lixin |
author_facet | Pan, Qi Li, Yijun Wan, Hailong Wang, Junfen Xu, Binhua Wang, Guoping Jiang, Chengxia Liang, Li Feng, Wei Liu, Jingcheng Wang, Ting Zhang, Xia Cui, Nan Mu, Yiming Guo, Lixin |
author_sort | Pan, Qi |
collection | PubMed |
description | AIM: To compare the efficacy and safety of basal insulin glargine 100 units/ml (Gla) + 2‐3 oral antihyperglycaemic drugs (OADs) with twice‐daily premixed insulin aspart 70/30 (Asp30) + metformin (MET) after short‐term intensive insulin therapy in adults with type 2 diabetes in China. MATERIALS AND METHODS: This open‐label trial enrolled insulin‐naïve adults with type 2 diabetes and an HbA1c of 7.5%‐11.0% (58‐97 mmol/mol) despite treatment with 2‐3 OADs. All participants stopped previous OADs except MET, then received short‐term intensive insulin therapy during the run‐in period, when those with a fasting plasma glucose of less than 7.0 mmol/L and 2‐hour postprandial glucose of less than 10.0 mmol/L were randomized to Gla + MET + a dipeptidyl peptidase‐4 inhibitor or twice‐daily Asp30 + MET. If HbA1c was more than 7.0% (>53 mmol/mol) at week 12, participants in the Gla group were added repaglinide or acarbose, at the physician's discretion, and participants in the Asp30 group continued to titrate insulin dose. The change in HbA1c from baseline to week 24 was assessed in the per protocol (PP) population (primary endpoint). RESULTS: There were 384 enrollees (192 each to Gla and Asp30); 367 were included in the PP analysis. The threshold for non‐inferiority of Gla + OADs versus Asp30 + MET was met, with a least squares mean change from baseline in HbA1c of –1.72% and –1.70% (–42.2 and –42.1 mmol/mol), respectively (estimated difference –0.01%; 95% CI –0.20%, 0.17% [–0.1 mmol/mol; 95% CI –2.2, 1.9]). Achievement of HbA1c less than 7.0% (<53 mmol/mol) was comparable between the groups (60% vs. 57%). The proportion of participants with any (24% vs. 38%; P = .003), symptomatic (19% vs. 31%; P = .007) or confirmed hypoglycaemia (18% vs. 33%; P < .001) was lower in the Gla + OADs group. CONCLUSIONS: Compared with Asp30 + MET, Gla + 2‐3 OADs showed similar efficacy but a lower hypoglycaemia risk in Chinese individuals with type 2 diabetes who had undergone short‐term intensive insulin therapy. |
format | Online Article Text |
id | pubmed-9543477 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Blackwell Publishing Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-95434772022-10-14 Efficacy and safety of a basal insulin + 2‐3 oral antihyperglycaemic drugs regimen versus a twice‐daily premixed insulin + metformin regimen after short‐term intensive insulin therapy in individuals with type 2 diabetes: The multicentre, open‐label, randomized controlled BEYOND‐V trial Pan, Qi Li, Yijun Wan, Hailong Wang, Junfen Xu, Binhua Wang, Guoping Jiang, Chengxia Liang, Li Feng, Wei Liu, Jingcheng Wang, Ting Zhang, Xia Cui, Nan Mu, Yiming Guo, Lixin Diabetes Obes Metab Original Articles AIM: To compare the efficacy and safety of basal insulin glargine 100 units/ml (Gla) + 2‐3 oral antihyperglycaemic drugs (OADs) with twice‐daily premixed insulin aspart 70/30 (Asp30) + metformin (MET) after short‐term intensive insulin therapy in adults with type 2 diabetes in China. MATERIALS AND METHODS: This open‐label trial enrolled insulin‐naïve adults with type 2 diabetes and an HbA1c of 7.5%‐11.0% (58‐97 mmol/mol) despite treatment with 2‐3 OADs. All participants stopped previous OADs except MET, then received short‐term intensive insulin therapy during the run‐in period, when those with a fasting plasma glucose of less than 7.0 mmol/L and 2‐hour postprandial glucose of less than 10.0 mmol/L were randomized to Gla + MET + a dipeptidyl peptidase‐4 inhibitor or twice‐daily Asp30 + MET. If HbA1c was more than 7.0% (>53 mmol/mol) at week 12, participants in the Gla group were added repaglinide or acarbose, at the physician's discretion, and participants in the Asp30 group continued to titrate insulin dose. The change in HbA1c from baseline to week 24 was assessed in the per protocol (PP) population (primary endpoint). RESULTS: There were 384 enrollees (192 each to Gla and Asp30); 367 were included in the PP analysis. The threshold for non‐inferiority of Gla + OADs versus Asp30 + MET was met, with a least squares mean change from baseline in HbA1c of –1.72% and –1.70% (–42.2 and –42.1 mmol/mol), respectively (estimated difference –0.01%; 95% CI –0.20%, 0.17% [–0.1 mmol/mol; 95% CI –2.2, 1.9]). Achievement of HbA1c less than 7.0% (<53 mmol/mol) was comparable between the groups (60% vs. 57%). The proportion of participants with any (24% vs. 38%; P = .003), symptomatic (19% vs. 31%; P = .007) or confirmed hypoglycaemia (18% vs. 33%; P < .001) was lower in the Gla + OADs group. CONCLUSIONS: Compared with Asp30 + MET, Gla + 2‐3 OADs showed similar efficacy but a lower hypoglycaemia risk in Chinese individuals with type 2 diabetes who had undergone short‐term intensive insulin therapy. Blackwell Publishing Ltd 2022-06-28 2022-10 /pmc/articles/PMC9543477/ /pubmed/35642463 http://dx.doi.org/10.1111/dom.14780 Text en © 2022 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://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 Pan, Qi Li, Yijun Wan, Hailong Wang, Junfen Xu, Binhua Wang, Guoping Jiang, Chengxia Liang, Li Feng, Wei Liu, Jingcheng Wang, Ting Zhang, Xia Cui, Nan Mu, Yiming Guo, Lixin Efficacy and safety of a basal insulin + 2‐3 oral antihyperglycaemic drugs regimen versus a twice‐daily premixed insulin + metformin regimen after short‐term intensive insulin therapy in individuals with type 2 diabetes: The multicentre, open‐label, randomized controlled BEYOND‐V trial |
title | Efficacy and safety of a basal insulin + 2‐3 oral antihyperglycaemic drugs regimen versus a twice‐daily premixed insulin + metformin regimen after short‐term intensive insulin therapy in individuals with type 2 diabetes: The multicentre, open‐label, randomized controlled BEYOND‐V trial |
title_full | Efficacy and safety of a basal insulin + 2‐3 oral antihyperglycaemic drugs regimen versus a twice‐daily premixed insulin + metformin regimen after short‐term intensive insulin therapy in individuals with type 2 diabetes: The multicentre, open‐label, randomized controlled BEYOND‐V trial |
title_fullStr | Efficacy and safety of a basal insulin + 2‐3 oral antihyperglycaemic drugs regimen versus a twice‐daily premixed insulin + metformin regimen after short‐term intensive insulin therapy in individuals with type 2 diabetes: The multicentre, open‐label, randomized controlled BEYOND‐V trial |
title_full_unstemmed | Efficacy and safety of a basal insulin + 2‐3 oral antihyperglycaemic drugs regimen versus a twice‐daily premixed insulin + metformin regimen after short‐term intensive insulin therapy in individuals with type 2 diabetes: The multicentre, open‐label, randomized controlled BEYOND‐V trial |
title_short | Efficacy and safety of a basal insulin + 2‐3 oral antihyperglycaemic drugs regimen versus a twice‐daily premixed insulin + metformin regimen after short‐term intensive insulin therapy in individuals with type 2 diabetes: The multicentre, open‐label, randomized controlled BEYOND‐V trial |
title_sort | efficacy and safety of a basal insulin + 2‐3 oral antihyperglycaemic drugs regimen versus a twice‐daily premixed insulin + metformin regimen after short‐term intensive insulin therapy in individuals with type 2 diabetes: the multicentre, open‐label, randomized controlled beyond‐v trial |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9543477/ https://www.ncbi.nlm.nih.gov/pubmed/35642463 http://dx.doi.org/10.1111/dom.14780 |
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