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
Abstract 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 phas...
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| Format: | Article |
| Language: | English |
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BMC
2023-10-01
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| Series: | BMC Medicine |
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| Online Access: | https://doi.org/10.1186/s12916-023-03089-x |
| _version_ | 1797452363649253376 |
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| author | Mingtong Xu Kan Sun Wenjie Xu Chuan Wang Dewen Yan Shu Li Li Cong Yinzhen Pi Weihong Song Qingyuan Sun Rijun Xiao Weixia Peng Jianping Wang Hui Peng Yawei Zhang Peng Duan Meiying Zhang Jianying Liu Qingmei Huang Xuefeng Li Yan Bao Tianshu Zeng Kun Wang Li Qin Chaoming Wu Chunying Deng Chenghu Huang Shuang Yan Wei Zhang Meizi Li Li Sun Yanjun Wang HongMei Li Guang Wang Shuguang Pang Xianling Zheng Haifang Wang Fujun Wang Xiuhai Su Yujin Ma Wei Zhang Ziling Li Zuoling Xie Ning Xu Lin Ni Li Zhang Xiangqun Deng Tianrong Pan Qijuan Dong Xiaohong Wu Xingping Shen Xin Zhang Qijing Zou Chengxia Jiang Jue Xi Jianhua Ma Jingchao Sun Li Yan |
| author_facet | Mingtong Xu Kan Sun Wenjie Xu Chuan Wang Dewen Yan Shu Li Li Cong Yinzhen Pi Weihong Song Qingyuan Sun Rijun Xiao Weixia Peng Jianping Wang Hui Peng Yawei Zhang Peng Duan Meiying Zhang Jianying Liu Qingmei Huang Xuefeng Li Yan Bao Tianshu Zeng Kun Wang Li Qin Chaoming Wu Chunying Deng Chenghu Huang Shuang Yan Wei Zhang Meizi Li Li Sun Yanjun Wang HongMei Li Guang Wang Shuguang Pang Xianling Zheng Haifang Wang Fujun Wang Xiuhai Su Yujin Ma Wei Zhang Ziling Li Zuoling Xie Ning Xu Lin Ni Li Zhang Xiangqun Deng Tianrong Pan Qijuan Dong Xiaohong Wu Xingping Shen Xin Zhang Qijing Zou Chengxia Jiang Jue Xi Jianhua Ma Jingchao Sun Li Yan |
| author_sort | Mingtong Xu |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-03-09T15:07:52Z |
| format | Article |
| id | doaj.art-717e454fe7ba4229acf874096588a7d3 |
| institution | Directory Open Access Journal |
| issn | 1741-7015 |
| language | English |
| last_indexed | 2024-03-09T15:07:52Z |
| publishDate | 2023-10-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medicine |
| spelling | doaj.art-717e454fe7ba4229acf874096588a7d32023-11-26T13:34:07ZengBMCBMC Medicine1741-70152023-10-0121111010.1186/s12916-023-03089-xFotagliptin monotherapy with alogliptin as an active comparator in patients with uncontrolled type 2 diabetes mellitus: a randomized, multicenter, double-blind, placebo-controlled, phase 3 trialMingtong Xu0Kan Sun1Wenjie Xu2Chuan Wang3Dewen Yan4Shu Li5Li Cong6Yinzhen Pi7Weihong Song8Qingyuan Sun9Rijun Xiao10Weixia Peng11Jianping Wang12Hui Peng13Yawei Zhang14Peng Duan15Meiying Zhang16Jianying Liu17Qingmei Huang18Xuefeng Li19Yan Bao20Tianshu Zeng21Kun Wang22Li Qin23Chaoming Wu24Chunying Deng25Chenghu Huang26Shuang Yan27Wei Zhang28Meizi Li29Li Sun30Yanjun Wang31HongMei Li32Guang Wang33Shuguang Pang34Xianling Zheng35Haifang Wang36Fujun Wang37Xiuhai Su38Yujin Ma39Wei Zhang40Ziling Li41Zuoling Xie42Ning Xu43Lin Ni44Li Zhang45Xiangqun Deng46Tianrong Pan47Qijuan Dong48Xiaohong Wu49Xingping Shen50Xin Zhang51Qijing Zou52Chengxia Jiang53Jue Xi54Jianhua Ma55Jingchao Sun56Li Yan57Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversitySun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityShenzhen Salubris Pharmaceuticals Co., LtdSun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityShenzhen Second People’s HospitalHuizhou Municipal Central HospitalThe Fifth Affiliated Hospital of Sun Yat-Sen UniversityThe First Hospital of ChangshaChenzhou First People’s HospitalYueyang Central HospitalThe First Peole’s Hospital of Xiangtan CityYiyang Central HospitalThe Second Affiliated Hospital of the University of South ChinaYichun People’s Hospital, The Affiliated Hospital of Yichun UniversityPingxiang People’s HospitalThe People’s Hospital of Nanchang, The Third Hospital of NanchangThe Second Affiliated Hospital of Nanchang UniversityThe First Affiliated Hospital of Nanchang UniversityXinyu People’s HospitalTaihe Hospital, Affilited Hospital of Hubei University of MedicineRenmin Hospital of Wuhan UniversityUnion Hospital, Tongji Medical College, Huazhong University of Science and TechnologyNanjing Jiangning Hospital, The Affiliated Jiangning Hospital of Nanjing Medical UniversityChongming Branch, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of MedicineThe 2nd School of Medicine, WMU, The 2nd Affiliated Hospital and Yuying Children’s Hospital of WMUZigong Fourth People’s HospitalBishan Hospital of Chongqing, Bishan Hospital of Chongqing Medical UniversityFourth affiliated hospital of Harbin Medical UniversityThe First Hospital of QiqiharThe Affiliated Hospital of Yanbian UniversitySiping Central People’s HospitalThe Second Norman Bethune Hospital of Jilin UniversityEmergency General HospitalBeijing Chao-Yang Hospital, Capital Medicine UniversityJinan Central Hospital, Central Hospital Affiliated to Shandong First Medical UniversityHandan Central HospitalHandan First HospitalThe Fourth Hospital of He Bei Medical UniversityCangzhou Hospital of Integrated TCM-WM HeibeiThe First Affiliated Hospital and College of Clinical Medicine, Henan University of Science and TechnologyPuyang Oilfield General HospitalInner Mongolia Baogang HospitaZhongda Hospital Southeast UniversityThe First People’s Hospital of LianyungangThe First People’s Hospital of Huzhou, The First Affiliated Hospital of Huzhou Teacher CollegeHainan Third People’s HospitalWuhan Third HospitalThe Second Hospital of Anhui Medical UniversityPeople’s Hospital of Zhengzhou, People’s Hospital of Henan University of Chinese MedicineZhejiang Provincial People’s Hospital, People’s Hospital of Hangzhou Medical CollegeZhongshan Hospital Xiamen UniversityGenertec Liaoyou Gem Flowe HospitalThe Central Hospital of YougzhouThe First People’s Hospital of ZunyiThe Affiliated Hospital of Xuzhou Medical UniversityNanjing First HospitalShenzhen Salubris Pharmaceuticals Co., LtdSun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityAbstract 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.https://doi.org/10.1186/s12916-023-03089-xDipeptidyl peptidase-4 inhibitorsFotagliptinType 2 diabetes mellitusHbA1c |
| spellingShingle | Mingtong Xu Kan Sun Wenjie Xu Chuan Wang Dewen Yan Shu Li Li Cong Yinzhen Pi Weihong Song Qingyuan Sun Rijun Xiao Weixia Peng Jianping Wang Hui Peng Yawei Zhang Peng Duan Meiying Zhang Jianying Liu Qingmei Huang Xuefeng Li Yan Bao Tianshu Zeng Kun Wang Li Qin Chaoming Wu Chunying Deng Chenghu Huang Shuang Yan Wei Zhang Meizi Li Li Sun Yanjun Wang HongMei Li Guang Wang Shuguang Pang Xianling Zheng Haifang Wang Fujun Wang Xiuhai Su Yujin Ma Wei Zhang Ziling Li Zuoling Xie Ning Xu Lin Ni Li Zhang Xiangqun Deng Tianrong Pan Qijuan Dong Xiaohong Wu Xingping Shen Xin Zhang Qijing Zou Chengxia Jiang Jue Xi Jianhua Ma Jingchao Sun Li Yan 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 BMC Medicine Dipeptidyl peptidase-4 inhibitors Fotagliptin Type 2 diabetes mellitus HbA1c |
| 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 | Dipeptidyl peptidase-4 inhibitors Fotagliptin Type 2 diabetes mellitus HbA1c |
| url | https://doi.org/10.1186/s12916-023-03089-x |
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