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Fotagliptin monotherapy with alogliptin as an active comparator in patients with uncontrolled type 2 diabetes mellitus: a randomized, multicenter, double-blind, placebo-controlled, phase 3 trial

BACKGROUND: Dipeptidyl peptidase-4 inhibitors (DPP-4i) have become firmly established in treatment algorithms and national guidelines for improving glycemic control in type 2 diabetes mellitus (T2DM).To report the findings from a multicenter, randomized, double-blind, placebo-controlled phase 3 clin...

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Autores principales: Xu, Mingtong, Sun, Kan, Xu, Wenjie, Wang, Chuan, Yan, Dewen, Li, Shu, Cong, Li, Pi, Yinzhen, Song, Weihong, Sun, Qingyuan, Xiao, Rijun, Peng, Weixia, Wang, Jianping, Peng, Hui, Zhang, Yawei, Duan, Peng, Zhang, Meiying, Liu, Jianying, Huang, Qingmei, Li, Xuefeng, Bao, Yan, Zeng, Tianshu, Wang, Kun, Qin, Li, Wu, Chaoming, Deng, Chunying, Huang, Chenghu, Yan, Shuang, Zhang, Wei, Li, Meizi, Sun, Li, Wang, Yanjun, Li, HongMei, Wang, Guang, Pang, Shuguang, Zheng, Xianling, Wang, Haifang, Wang, Fujun, Su, Xiuhai, Ma, Yujin, Li, Ziling, Xie, Zuoling, Xu, Ning, Ni, Lin, Zhang, Li, Deng, Xiangqun, Pan, Tianrong, Dong, Qijuan, Wu, Xiaohong, Shen, Xingping, Zhang, Xin, Zou, Qijing, Jiang, Chengxia, Xi, Jue, Ma, Jianhua, Sun, Jingchao, Yan, Li
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10563289/
https://www.ncbi.nlm.nih.gov/pubmed/37814306
http://dx.doi.org/10.1186/s12916-023-03089-x
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author Xu, Mingtong
Sun, Kan
Xu, Wenjie
Wang, Chuan
Yan, Dewen
Li, Shu
Cong, Li
Pi, Yinzhen
Song, Weihong
Sun, Qingyuan
Xiao, Rijun
Peng, Weixia
Wang, Jianping
Peng, Hui
Zhang, Yawei
Duan, Peng
Zhang, Meiying
Liu, Jianying
Huang, Qingmei
Li, Xuefeng
Bao, Yan
Zeng, Tianshu
Wang, Kun
Qin, Li
Wu, Chaoming
Deng, Chunying
Huang, Chenghu
Yan, Shuang
Zhang, Wei
Li, Meizi
Sun, Li
Wang, Yanjun
Li, HongMei
Wang, Guang
Pang, Shuguang
Zheng, Xianling
Wang, Haifang
Wang, Fujun
Su, Xiuhai
Ma, Yujin
Zhang, Wei
Li, Ziling
Xie, Zuoling
Xu, Ning
Ni, Lin
Zhang, Li
Deng, Xiangqun
Pan, Tianrong
Dong, Qijuan
Wu, Xiaohong
Shen, Xingping
Zhang, Xin
Zou, Qijing
Jiang, Chengxia
Xi, Jue
Ma, Jianhua
Sun, Jingchao
Yan, Li
author_facet Xu, Mingtong
Sun, Kan
Xu, Wenjie
Wang, Chuan
Yan, Dewen
Li, Shu
Cong, Li
Pi, Yinzhen
Song, Weihong
Sun, Qingyuan
Xiao, Rijun
Peng, Weixia
Wang, Jianping
Peng, Hui
Zhang, Yawei
Duan, Peng
Zhang, Meiying
Liu, Jianying
Huang, Qingmei
Li, Xuefeng
Bao, Yan
Zeng, Tianshu
Wang, Kun
Qin, Li
Wu, Chaoming
Deng, Chunying
Huang, Chenghu
Yan, Shuang
Zhang, Wei
Li, Meizi
Sun, Li
Wang, Yanjun
Li, HongMei
Wang, Guang
Pang, Shuguang
Zheng, Xianling
Wang, Haifang
Wang, Fujun
Su, Xiuhai
Ma, Yujin
Zhang, Wei
Li, Ziling
Xie, Zuoling
Xu, Ning
Ni, Lin
Zhang, Li
Deng, Xiangqun
Pan, Tianrong
Dong, Qijuan
Wu, Xiaohong
Shen, Xingping
Zhang, Xin
Zou, Qijing
Jiang, Chengxia
Xi, Jue
Ma, Jianhua
Sun, Jingchao
Yan, Li
author_sort Xu, Mingtong
collection PubMed
description BACKGROUND: Dipeptidyl peptidase-4 inhibitors (DPP-4i) have become firmly established in treatment algorithms and national guidelines for improving glycemic control in type 2 diabetes mellitus (T2DM).To report the findings from a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial, which was designed to assess the efficacy and safety of a novel DPP-4 inhibitor fotagliptin in treatment-naive patients with T2DM. METHODS: Patients with T2DM were randomized to receive fotagliptin (n = 230), alogliptin (n = 113) or placebo (n = 115) at a 2:1:1 ratio for 24 weeks of double-blind treatment period, followed by an open-label treatment period, making up a total of 52 weeks. The primary efficacy endpoint was to determine the superiority of fotagliptin over placebo in the change of HbA1c from baseline to Week 24. All serious or significant adverse events were recorded. RESULTS: After 24 weeks, mean decreases in HbA1c from baseline were -0.70% for fotagliptin, -0.72% for alogliptin and -0.26% for placebo. Estimated mean treatment differences in HbA1c were -0.44% (95% confidence interval [CI]: -0.62% to -0.27%) for fotagliptin versus placebo, and -0.46% (95% CI: -0.67% to -0.26%) for alogliptin versus placebo, and 0.02% (95%CI: -0.16% to 0.19%; upper limit of 95%CI < margin of 0.4%) for fotagliptin versus alogliptin. So fotagliptin was non-inferior to alogliptin. Compared with subjects with placebo (15.5%), significantly more patients with fotagliptin (37.0%) and alogliptin (35.5%) achieved HbA1c < 7.0% after 24 weeks of treatment. During the whole 52 weeks of treatment, the overall incidence of hypoglycemia was low for both of the fotagliptin and alogliptin groups (1.0% each). No drug-related serious adverse events were observed in any treatment group. CONCLUSIONS: In summary, the study demonstrated improvement in glycemic control and a favorable safety profile for fotagliptin in treatment-naive patients with T2DM. TRIAL REGISTRATION: ClinicalTrail.gov NCT05782192. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12916-023-03089-x.
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spelling pubmed-105632892023-10-11 Fotagliptin monotherapy with alogliptin as an active comparator in patients with uncontrolled type 2 diabetes mellitus: a randomized, multicenter, double-blind, placebo-controlled, phase 3 trial Xu, Mingtong Sun, Kan Xu, Wenjie Wang, Chuan Yan, Dewen Li, Shu Cong, Li Pi, Yinzhen Song, Weihong Sun, Qingyuan Xiao, Rijun Peng, Weixia Wang, Jianping Peng, Hui Zhang, Yawei Duan, Peng Zhang, Meiying Liu, Jianying Huang, Qingmei Li, Xuefeng Bao, Yan Zeng, Tianshu Wang, Kun Qin, Li Wu, Chaoming Deng, Chunying Huang, Chenghu Yan, Shuang Zhang, Wei Li, Meizi Sun, Li Wang, Yanjun Li, HongMei Wang, Guang Pang, Shuguang Zheng, Xianling Wang, Haifang Wang, Fujun Su, Xiuhai Ma, Yujin Zhang, Wei Li, Ziling Xie, Zuoling Xu, Ning Ni, Lin Zhang, Li Deng, Xiangqun Pan, Tianrong Dong, Qijuan Wu, Xiaohong Shen, Xingping Zhang, Xin Zou, Qijing Jiang, Chengxia Xi, Jue Ma, Jianhua Sun, Jingchao Yan, Li BMC Med Research Article BACKGROUND: Dipeptidyl peptidase-4 inhibitors (DPP-4i) have become firmly established in treatment algorithms and national guidelines for improving glycemic control in type 2 diabetes mellitus (T2DM).To report the findings from a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial, which was designed to assess the efficacy and safety of a novel DPP-4 inhibitor fotagliptin in treatment-naive patients with T2DM. METHODS: Patients with T2DM were randomized to receive fotagliptin (n = 230), alogliptin (n = 113) or placebo (n = 115) at a 2:1:1 ratio for 24 weeks of double-blind treatment period, followed by an open-label treatment period, making up a total of 52 weeks. The primary efficacy endpoint was to determine the superiority of fotagliptin over placebo in the change of HbA1c from baseline to Week 24. All serious or significant adverse events were recorded. RESULTS: After 24 weeks, mean decreases in HbA1c from baseline were -0.70% for fotagliptin, -0.72% for alogliptin and -0.26% for placebo. Estimated mean treatment differences in HbA1c were -0.44% (95% confidence interval [CI]: -0.62% to -0.27%) for fotagliptin versus placebo, and -0.46% (95% CI: -0.67% to -0.26%) for alogliptin versus placebo, and 0.02% (95%CI: -0.16% to 0.19%; upper limit of 95%CI < margin of 0.4%) for fotagliptin versus alogliptin. So fotagliptin was non-inferior to alogliptin. Compared with subjects with placebo (15.5%), significantly more patients with fotagliptin (37.0%) and alogliptin (35.5%) achieved HbA1c < 7.0% after 24 weeks of treatment. During the whole 52 weeks of treatment, the overall incidence of hypoglycemia was low for both of the fotagliptin and alogliptin groups (1.0% each). No drug-related serious adverse events were observed in any treatment group. CONCLUSIONS: In summary, the study demonstrated improvement in glycemic control and a favorable safety profile for fotagliptin in treatment-naive patients with T2DM. TRIAL REGISTRATION: ClinicalTrail.gov NCT05782192. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12916-023-03089-x. BioMed Central 2023-10-09 /pmc/articles/PMC10563289/ /pubmed/37814306 http://dx.doi.org/10.1186/s12916-023-03089-x Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research Article
Xu, Mingtong
Sun, Kan
Xu, Wenjie
Wang, Chuan
Yan, Dewen
Li, Shu
Cong, Li
Pi, Yinzhen
Song, Weihong
Sun, Qingyuan
Xiao, Rijun
Peng, Weixia
Wang, Jianping
Peng, Hui
Zhang, Yawei
Duan, Peng
Zhang, Meiying
Liu, Jianying
Huang, Qingmei
Li, Xuefeng
Bao, Yan
Zeng, Tianshu
Wang, Kun
Qin, Li
Wu, Chaoming
Deng, Chunying
Huang, Chenghu
Yan, Shuang
Zhang, Wei
Li, Meizi
Sun, Li
Wang, Yanjun
Li, HongMei
Wang, Guang
Pang, Shuguang
Zheng, Xianling
Wang, Haifang
Wang, Fujun
Su, Xiuhai
Ma, Yujin
Zhang, Wei
Li, Ziling
Xie, Zuoling
Xu, Ning
Ni, Lin
Zhang, Li
Deng, Xiangqun
Pan, Tianrong
Dong, Qijuan
Wu, Xiaohong
Shen, Xingping
Zhang, Xin
Zou, Qijing
Jiang, Chengxia
Xi, Jue
Ma, Jianhua
Sun, Jingchao
Yan, Li
Fotagliptin monotherapy with alogliptin as an active comparator in patients with uncontrolled type 2 diabetes mellitus: a randomized, multicenter, double-blind, placebo-controlled, phase 3 trial
title Fotagliptin monotherapy with alogliptin as an active comparator in patients with uncontrolled type 2 diabetes mellitus: a randomized, multicenter, double-blind, placebo-controlled, phase 3 trial
title_full Fotagliptin monotherapy with alogliptin as an active comparator in patients with uncontrolled type 2 diabetes mellitus: a randomized, multicenter, double-blind, placebo-controlled, phase 3 trial
title_fullStr Fotagliptin monotherapy with alogliptin as an active comparator in patients with uncontrolled type 2 diabetes mellitus: a randomized, multicenter, double-blind, placebo-controlled, phase 3 trial
title_full_unstemmed Fotagliptin monotherapy with alogliptin as an active comparator in patients with uncontrolled type 2 diabetes mellitus: a randomized, multicenter, double-blind, placebo-controlled, phase 3 trial
title_short Fotagliptin monotherapy with alogliptin as an active comparator in patients with uncontrolled type 2 diabetes mellitus: a randomized, multicenter, double-blind, placebo-controlled, phase 3 trial
title_sort fotagliptin monotherapy with alogliptin as an active comparator in patients with uncontrolled type 2 diabetes mellitus: a randomized, multicenter, double-blind, placebo-controlled, phase 3 trial
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10563289/
https://www.ncbi.nlm.nih.gov/pubmed/37814306
http://dx.doi.org/10.1186/s12916-023-03089-x
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