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Efficacy and Safety of Lixisenatide Once Daily Versus Exenatide Twice Daily in Type 2 Diabetes Inadequately Controlled on Metformin: A 24-week, randomized, open-label, active-controlled study (GetGoal-X)
OBJECTIVE: To compare efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled with metformin. RESEARCH DESIGN AND METHODS: Adults with diabetes inadequately controlled (HbA(1c) 7–10%) with metformin were randomized to lixisenatide 20 μg...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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American Diabetes Association
2013
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3781502/ https://www.ncbi.nlm.nih.gov/pubmed/23698396 http://dx.doi.org/10.2337/dc12-2709 |
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author | Rosenstock, Julio Raccah, Denis Korányi, László Maffei, Laura Boka, Gabor Miossec, Patrick Gerich, John E. |
author_facet | Rosenstock, Julio Raccah, Denis Korányi, László Maffei, Laura Boka, Gabor Miossec, Patrick Gerich, John E. |
author_sort | Rosenstock, Julio |
collection | PubMed |
description | OBJECTIVE: To compare efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled with metformin. RESEARCH DESIGN AND METHODS: Adults with diabetes inadequately controlled (HbA(1c) 7–10%) with metformin were randomized to lixisenatide 20 μg once daily (n = 318) or exenatide 10 μg twice daily (n = 316) in a 24-week (main period), open-label, parallel-group, multicenter study. The primary objective was a noninferiority assessment of lixisenatide versus exenatide in HbA(1c) change from baseline to week 24. RESULTS: Lixisenatide once daily demonstrated noninferiority in HbA(1c) reduction versus exenatide twice daily. The least squares mean change was −0.79% (mean decrease 7.97 to 7.17%) for lixisenatide versus −0.96% (mean decrease 7.96 to 7.01%) for exenatide, and treatment difference was 0.17% (95% CI, 0.033–0.297), meeting a predefined noninferiority upper CI margin of 0.4%. Responder rate (HbA(1c) <7.0%) and improvements in fasting plasma glucose were comparable. Both agents induced weight loss (from 94.5 to 91.7 kg and from 96.7 to 92.9 kg with lixisenatide and exenatide, respectively). Incidence of adverse events (AEs) was similar for lixisenatide and exenatide, as was incidence of serious AEs (2.8 and 2.2%, respectively). Discontinuations attributable to AEs occurred in 33 lixisenatide (10.4%) and 41 exenatide (13.0%) patients. In the lixisenatide group, fewer participants experienced symptomatic hypoglycemia (2.5 vs. 7.9%; P < 0.05), with fewer gastrointestinal events (especially nausea; 24.5 vs. 35.1%; P < 0.05). CONCLUSIONS: Add-on lixisenatide once daily in type 2 diabetes inadequately controlled with metformin demonstrated noninferior improvements in HbA(1c), with slightly lower mean weight loss, lower incidence of hypoglycemia, and better gastrointestinal tolerability compared with exenatide twice daily. |
format | Online Article Text |
id | pubmed-3781502 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | American Diabetes Association |
record_format | MEDLINE/PubMed |
spelling | pubmed-37815022014-10-01 Efficacy and Safety of Lixisenatide Once Daily Versus Exenatide Twice Daily in Type 2 Diabetes Inadequately Controlled on Metformin: A 24-week, randomized, open-label, active-controlled study (GetGoal-X) Rosenstock, Julio Raccah, Denis Korányi, László Maffei, Laura Boka, Gabor Miossec, Patrick Gerich, John E. Diabetes Care Original Research OBJECTIVE: To compare efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled with metformin. RESEARCH DESIGN AND METHODS: Adults with diabetes inadequately controlled (HbA(1c) 7–10%) with metformin were randomized to lixisenatide 20 μg once daily (n = 318) or exenatide 10 μg twice daily (n = 316) in a 24-week (main period), open-label, parallel-group, multicenter study. The primary objective was a noninferiority assessment of lixisenatide versus exenatide in HbA(1c) change from baseline to week 24. RESULTS: Lixisenatide once daily demonstrated noninferiority in HbA(1c) reduction versus exenatide twice daily. The least squares mean change was −0.79% (mean decrease 7.97 to 7.17%) for lixisenatide versus −0.96% (mean decrease 7.96 to 7.01%) for exenatide, and treatment difference was 0.17% (95% CI, 0.033–0.297), meeting a predefined noninferiority upper CI margin of 0.4%. Responder rate (HbA(1c) <7.0%) and improvements in fasting plasma glucose were comparable. Both agents induced weight loss (from 94.5 to 91.7 kg and from 96.7 to 92.9 kg with lixisenatide and exenatide, respectively). Incidence of adverse events (AEs) was similar for lixisenatide and exenatide, as was incidence of serious AEs (2.8 and 2.2%, respectively). Discontinuations attributable to AEs occurred in 33 lixisenatide (10.4%) and 41 exenatide (13.0%) patients. In the lixisenatide group, fewer participants experienced symptomatic hypoglycemia (2.5 vs. 7.9%; P < 0.05), with fewer gastrointestinal events (especially nausea; 24.5 vs. 35.1%; P < 0.05). CONCLUSIONS: Add-on lixisenatide once daily in type 2 diabetes inadequately controlled with metformin demonstrated noninferior improvements in HbA(1c), with slightly lower mean weight loss, lower incidence of hypoglycemia, and better gastrointestinal tolerability compared with exenatide twice daily. American Diabetes Association 2013-10 2013-09-14 /pmc/articles/PMC3781502/ /pubmed/23698396 http://dx.doi.org/10.2337/dc12-2709 Text en © 2013 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details. |
spellingShingle | Original Research Rosenstock, Julio Raccah, Denis Korányi, László Maffei, Laura Boka, Gabor Miossec, Patrick Gerich, John E. Efficacy and Safety of Lixisenatide Once Daily Versus Exenatide Twice Daily in Type 2 Diabetes Inadequately Controlled on Metformin: A 24-week, randomized, open-label, active-controlled study (GetGoal-X) |
title | Efficacy and Safety of Lixisenatide Once Daily Versus Exenatide Twice Daily in Type 2 Diabetes Inadequately Controlled on Metformin: A 24-week, randomized, open-label, active-controlled study (GetGoal-X) |
title_full | Efficacy and Safety of Lixisenatide Once Daily Versus Exenatide Twice Daily in Type 2 Diabetes Inadequately Controlled on Metformin: A 24-week, randomized, open-label, active-controlled study (GetGoal-X) |
title_fullStr | Efficacy and Safety of Lixisenatide Once Daily Versus Exenatide Twice Daily in Type 2 Diabetes Inadequately Controlled on Metformin: A 24-week, randomized, open-label, active-controlled study (GetGoal-X) |
title_full_unstemmed | Efficacy and Safety of Lixisenatide Once Daily Versus Exenatide Twice Daily in Type 2 Diabetes Inadequately Controlled on Metformin: A 24-week, randomized, open-label, active-controlled study (GetGoal-X) |
title_short | Efficacy and Safety of Lixisenatide Once Daily Versus Exenatide Twice Daily in Type 2 Diabetes Inadequately Controlled on Metformin: A 24-week, randomized, open-label, active-controlled study (GetGoal-X) |
title_sort | efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled on metformin: a 24-week, randomized, open-label, active-controlled study (getgoal-x) |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3781502/ https://www.ncbi.nlm.nih.gov/pubmed/23698396 http://dx.doi.org/10.2337/dc12-2709 |
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