Safety and pharmacokinetic interaction between fotagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin in healthy subjects

Ding, Yanhua; Zhang, Hong; Li, Cuiyun; Zheng, Wenbo; Wang, Meng; Liu, Ying; Sun, Hai-Gang; Wu, Min

doi:10.1080/17425255.2021.1915283

Cited by 1 publication

(2 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Fotagliptin is a novel highly selective DPP-4 inhibitor under clinical development for the increased levels of intact bioactive GIP and GLP-1. Based on previous studies, fotagliptin could increase active GLP-1 concentrations and have no obvious influence on DPP-8 and DPP-9, thus making it safer to treat T2DM [ 13 ]. To our knowledge, this was the first adequately powered trial to investigate the efficacy and safety profiles of fotagliptin in patients with uncontrolled T2DM.…”

Section: Discussionmentioning

confidence: 99%

“…Fotagliptin exhibited favorable pharmacokinetic results as it can achieve high and steady DPP-4 inhibition. Fotagliptin was rapidly absorbed, which t max was obtained at 1–2 h in T2DM patients, also enabling a maximum inhibition of DPP-4 within 1–2 h post administration [ 12 , 13 ]. Recently, a phase 1 clinical trial has been conducted in fourteen eligible Chinese patients with T2DM, which showed that fotagliptin was safe and well tolerated [ 12 ].…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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,

Sun,

et al. 2023

BMC Med

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionmentioning

confidence: 99%