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Combination therapy with liraglutide and insulin in Japanese patients with type 2 diabetes: A 36‐week, randomized, double‐blind, parallel‐group trial

AIMS/INTRODUCTION: To assess efficacy and safety of liraglutide in combination with insulin compared with insulin monotherapy in Japanese patients with type 2 diabetes. MATERIALS AND METHODS: This was a 36‐week, multicenter, double‐blind, parallel‐group trial, where patients on stable insulin therap...

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Autores principales: Seino, Yutaka, Kaneko, Shizuka, Fukuda, Shuichi, Osonoi, Takeshi, Shiraiwa, Toshihiko, Nishijima, Keiji, Bosch‐Traberg, Heidrun, Kaku, Kohei
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4931207/
https://www.ncbi.nlm.nih.gov/pubmed/27182042
http://dx.doi.org/10.1111/jdi.12457
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author Seino, Yutaka
Kaneko, Shizuka
Fukuda, Shuichi
Osonoi, Takeshi
Shiraiwa, Toshihiko
Nishijima, Keiji
Bosch‐Traberg, Heidrun
Kaku, Kohei
author_facet Seino, Yutaka
Kaneko, Shizuka
Fukuda, Shuichi
Osonoi, Takeshi
Shiraiwa, Toshihiko
Nishijima, Keiji
Bosch‐Traberg, Heidrun
Kaku, Kohei
author_sort Seino, Yutaka
collection PubMed
description AIMS/INTRODUCTION: To assess efficacy and safety of liraglutide in combination with insulin compared with insulin monotherapy in Japanese patients with type 2 diabetes. MATERIALS AND METHODS: This was a 36‐week, multicenter, double‐blind, parallel‐group trial, where patients on stable insulin therapy (basal/premixed/basal–bolus) were randomized 1:1 to additional liraglutide 0.9 mg/day (n = 127) or placebo (n = 130). The insulin dose was fixed for 16 weeks, and titrated based on self‐measured plasma glucose thereafter. The primary end‐point was change in glycosylated hemoglobin after 16 weeks. RESULTS: Superiority of liraglutide plus insulin versus insulin monotherapy was confirmed based on estimated mean difference in glycosylated hemoglobin after 16 weeks of −1.30% (−14 mmol/mol; 95% confidence interval −1.47 to −1.13 [−16, −12]; P < 0.0001). Statistical significance was maintained to week 36. More patients on liraglutide achieved a glycosylated hemoglobin target of <7.0% (<53 mmol/mol) at week 16 (estimated odds ratio 50.57; 95% confidence interval 16.59 to 154.16; P < 0.0001). Improvements in seven‐point self‐measured plasma glucose and fasting plasma glucose were significantly greater with liraglutide than the placebo at week 16. Insulin dose after 36 weeks was lower with liraglutide than the placebo (estimated treatment ratio: 0.82 [95% confidence interval 0.76–0.90; P < 0.0001]). Occurrence of adverse events was similar in the two groups (85.8 and 81.5%, respectively); most were mild in severity. There were no significant differences in the number of hypoglycemic episodes during the 36 weeks. CONCLUSIONS: Adding liraglutide to insulin results in superior glycemic control compared with insulin alone in Japanese patients with type 2 diabetes, and is generally well tolerated.
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spelling pubmed-49312072016-07-06 Combination therapy with liraglutide and insulin in Japanese patients with type 2 diabetes: A 36‐week, randomized, double‐blind, parallel‐group trial Seino, Yutaka Kaneko, Shizuka Fukuda, Shuichi Osonoi, Takeshi Shiraiwa, Toshihiko Nishijima, Keiji Bosch‐Traberg, Heidrun Kaku, Kohei J Diabetes Investig Articles AIMS/INTRODUCTION: To assess efficacy and safety of liraglutide in combination with insulin compared with insulin monotherapy in Japanese patients with type 2 diabetes. MATERIALS AND METHODS: This was a 36‐week, multicenter, double‐blind, parallel‐group trial, where patients on stable insulin therapy (basal/premixed/basal–bolus) were randomized 1:1 to additional liraglutide 0.9 mg/day (n = 127) or placebo (n = 130). The insulin dose was fixed for 16 weeks, and titrated based on self‐measured plasma glucose thereafter. The primary end‐point was change in glycosylated hemoglobin after 16 weeks. RESULTS: Superiority of liraglutide plus insulin versus insulin monotherapy was confirmed based on estimated mean difference in glycosylated hemoglobin after 16 weeks of −1.30% (−14 mmol/mol; 95% confidence interval −1.47 to −1.13 [−16, −12]; P < 0.0001). Statistical significance was maintained to week 36. More patients on liraglutide achieved a glycosylated hemoglobin target of <7.0% (<53 mmol/mol) at week 16 (estimated odds ratio 50.57; 95% confidence interval 16.59 to 154.16; P < 0.0001). Improvements in seven‐point self‐measured plasma glucose and fasting plasma glucose were significantly greater with liraglutide than the placebo at week 16. Insulin dose after 36 weeks was lower with liraglutide than the placebo (estimated treatment ratio: 0.82 [95% confidence interval 0.76–0.90; P < 0.0001]). Occurrence of adverse events was similar in the two groups (85.8 and 81.5%, respectively); most were mild in severity. There were no significant differences in the number of hypoglycemic episodes during the 36 weeks. CONCLUSIONS: Adding liraglutide to insulin results in superior glycemic control compared with insulin alone in Japanese patients with type 2 diabetes, and is generally well tolerated. John Wiley and Sons Inc. 2016-01-23 2016-07 /pmc/articles/PMC4931207/ /pubmed/27182042 http://dx.doi.org/10.1111/jdi.12457 Text en © 2015 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, 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 Articles
Seino, Yutaka
Kaneko, Shizuka
Fukuda, Shuichi
Osonoi, Takeshi
Shiraiwa, Toshihiko
Nishijima, Keiji
Bosch‐Traberg, Heidrun
Kaku, Kohei
Combination therapy with liraglutide and insulin in Japanese patients with type 2 diabetes: A 36‐week, randomized, double‐blind, parallel‐group trial
title Combination therapy with liraglutide and insulin in Japanese patients with type 2 diabetes: A 36‐week, randomized, double‐blind, parallel‐group trial
title_full Combination therapy with liraglutide and insulin in Japanese patients with type 2 diabetes: A 36‐week, randomized, double‐blind, parallel‐group trial
title_fullStr Combination therapy with liraglutide and insulin in Japanese patients with type 2 diabetes: A 36‐week, randomized, double‐blind, parallel‐group trial
title_full_unstemmed Combination therapy with liraglutide and insulin in Japanese patients with type 2 diabetes: A 36‐week, randomized, double‐blind, parallel‐group trial
title_short Combination therapy with liraglutide and insulin in Japanese patients with type 2 diabetes: A 36‐week, randomized, double‐blind, parallel‐group trial
title_sort combination therapy with liraglutide and insulin in japanese patients with type 2 diabetes: a 36‐week, randomized, double‐blind, parallel‐group trial
topic Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4931207/
https://www.ncbi.nlm.nih.gov/pubmed/27182042
http://dx.doi.org/10.1111/jdi.12457
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