Dataset Information

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 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.

SUBMITTER: Xu M

PROVIDER: S-EPMC10563289 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature

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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.

Xu Mingtong M Sun Kan K Xu Wenjie W Wang Chuan C Yan Dewen D Li Shu S Cong Li L Pi Yinzhen Y Song Weihong W Sun Qingyuan Q Xiao Rijun R Peng Weixia W Wang Jianping J Peng Hui H Zhang Yawei Y Duan Peng P Zhang Meiying M Liu Jianying J Huang Qingmei Q Li Xuefeng X Bao Yan Y Zeng Tianshu T Wang Kun K Qin Li L Wu Chaoming C Deng Chunying C Huang Chenghu C Yan Shuang S Zhang Wei W Li Meizi M Sun Li L Wang Yanjun Y Li HongMei H Wang Guang G Pang Shuguang S Zheng Xianling X Wang Haifang H Wang Fujun F Su Xiuhai X Ma Yujin Y Zhang Wei W Li Ziling Z Xie Zuoling Z Xu Ning N Ni Lin L Zhang Li L Deng Xiangqun X Pan Tianrong T Dong Qijuan Q Wu Xiaohong X Shen Xingping X Zhang Xin X Zou Qijing Q Jiang Chengxia C Xi Jue J Ma Jianhua J Sun Jingchao J Yan Li L

BMC medicine 20231009 1

<h4>Background</h4>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.<h4>Methods</h4>Patients with T2DM were randomized ...[more]

PMID: 37814306

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Dataset Information

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

Methods

Results

Conclusions

Trial registration

Publications

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.

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