[Translation] Phase I clinical trial of substance balance and biotransformation of [14C] senagliptin phosphate in healthy adult male volunteers in China

本试验旨在评价中国男性健康志愿者单剂量口服[14C]磷酸盛格列汀的物质平衡及生物转化途径。评价磷酸盛格列汀在人体内的药代动力学整体特征，为药物的合理使用提供参考。

[Translation]

This study aims to evaluate the material balance and biotransformation pathways of [14C] senolagliptin phosphate after a single oral dose in healthy Chinese male volunteers. The overall pharmacokinetic characteristics of senolagliptin phosphate in humans are evaluated to provide a reference for the rational use of the drug.

Start Date07 Jul 2020

Sponsor / Collaborator

CGeneTech (Suzhou, China) Co. Ltd.

CTR20200157 / CompletedPhase 3

一项多中心、随机、双盲、安慰剂对照评价盛格列汀联合二甲双胍治疗2型糖尿病患者的有效性和安全性临床研究

[Translation] A multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of senagliflozin combined with metformin in the treatment of patients with type 2 diabetes

主要目的：在二甲双胍单药治疗血糖控制不佳的中国成人2型糖尿病患者中，评价磷酸盛格列汀片（50mg和100mg）联合二甲双胍治疗24周的有效性，验证磷酸盛格列汀片联合二甲双胍的疗效优于安慰剂联合二甲双胍。

[Translation]

Primary objective: To evaluate the efficacy of senoside phosphate tablets (50 mg and 100 mg) combined with metformin for 24 weeks in Chinese adult patients with type 2 diabetes who have poor glycemic control on metformin monotherapy, and to verify that the efficacy of senoside phosphate tablets combined with metformin is superior to that of placebo combined with metformin.

Start Date27 Apr 2020

Sponsor / Collaborator

CGeneTech (Suzhou, China) Co. Ltd.

CTR20200172 / CompletedPhase 3

一项多中心、随机、双盲、安慰剂平行对照评价磷酸盛格列汀片单药治疗2型糖尿病患者的有效性和安全性研究

[Translation] A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of senolytic phosphate monotherapy in patients with type 2 diabetes

主要目的：在经饮食和运动治疗后血糖控制不佳的中国成人2型糖尿病患者中，评价磷酸盛格列汀片（50mg、100mg）单药治疗24周的有效性，验证磷酸盛格列汀片的疗效优于安慰剂。

[Translation]

Primary objective: To evaluate the efficacy of 24-week monotherapy with senolagliptin phosphate tablets (50 mg, 100 mg) in Chinese adults with type 2 diabetes who have poor blood sugar control after diet and exercise therapy, and to verify that the efficacy of senolagliptin phosphate tablets is superior to placebo.

Start Date20 Apr 2020

Sponsor / Collaborator

CGeneTech (Suzhou, China) Co. Ltd.

100 Clinical Results associated with Cetagliptin Phosphate

100 Translational Medicine associated with Cetagliptin Phosphate

100 Patents (Medical) associated with Cetagliptin Phosphate

Literatures (Medical) associated with Cetagliptin Phosphate

01 Dec 2023·Diabetes, Obesity and Metabolism

Efficacy and safety of cetagliptin as monotherapy in patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled phase 3 trial

Article

Author: Ying, Changjiang ; Ji, Linong ; Wang, Tong ; Xie, Daosheng ; Gao, Leili ; Ding, Juping ; Wang, Kun ; Lu, Jinmiao ; Zhao, Wenhua ; Zhao, Jiahong ; Han, Jie ; Sun, Jiao ; Gao, Yunming ; Zheng, Xin ; Yu, Qiang

AbstractAimTo assess the efficacy and safety of the dipeptidyl peptidase‐4 inhibitor, cetagliptin, as monotherapy in Chinese patients with type 2 diabetes (T2D) and inadequate glycaemic control.Materials and MethodsIn total, 504 eligible patients with T2D were enrolled and randomized to cetagliptin 50 mg once daily, cetagliptin 100 mg once daily or placebo at a ratio of 2:2:1 for 24 weeks of double‐blind treatment, then all patients received cetagliptin 100 mg once daily for 28 weeks of open‐label treatment. The primary efficacy endpoint was the change in HbA1c level from baseline at week 24.ResultsAfter 24 weeks, HbA1c from baseline was significantly reduced with cetagliptin 50 mg (−1.08%) and cetagliptin 100 mg (−1.07%) compared with placebo (−0.35%). The placebo‐subtracted HbA1c reduction was −0.72% with cetagliptin 50 mg and 100 mg. Patients with a baseline HbA1c of 8.5% or higher had a greater HbA1c reduction with cetagliptin than those patients with a baseline HbA1c of less than 8.5%. Both doses studied led to a significantly higher proportion of patients (42.3% with 100 mg and 45.0% with 50 mg) achieving an HbA1c of less than 7.0% compared with placebo (12.9%). Cetagliptin also significantly lowered fasting plasma glucose and 2‐hour postmeal plasma glucose relative to placebo. The incidence of adverse experiences was similar between cetagliptin and placebo. No drug‐related hypoglycaemia was reported.ConclusionsCetagliptin monotherapy was effective and well tolerated in Chinese patients with T2D who had inadequate glycaemic control on exercise and diet.

01 Dec 2023·Diabetes, Obesity and Metabolism

A randomized, double‐blind, placebo controlled, phase 3 trial to evaluate the efficacy and safety of cetagliptin added to ongoing metformin therapy in patients with uncontrolled type 2 diabetes with metformin monotherapy

Article

Author: Ding, Juping ; Ji, Linong ; Wang, Tong ; Cheng, Zhifeng ; Zhang, Lili ; Xie, Daosheng ; Gao, Leili ; Li, Jifang ; Lu, Jinmiao ; Li, Ping ; Yan, Xiaoguang ; Zhao, Jiahong ; Tian, Junhang ; Yu, Qiang ; Bai, Jie

AbstractAimThis trial was designed to assess the efficacy and safety of cetagliptin added to metformin in Chinese patients with type 2 diabetes who had inadequate glycaemic control with metformin monotherapy.MethodsIn total, 446 patients with type 2 diabetes on metformin monotherapy were randomized to receive the addition of once‐daily cetagliptin 100 mg, cetagliptin 50 mg and placebo in a 2:2:1 ratio for 24‐week double‐blind treatment. At week 24, patients initially randomized to cetagliptin 50 mg and placebo were switched to cetagliptin 100 mg for 28 weeks open‐label treatment. The primary endpoint was the change in haemoglobin A1c (HbA1c) from baseline, and the efficacy analyses were based on an all‐patients‐treated population using an analysis of co‐variance.ResultsAfter 24 weeks, both add‐on therapies led to greater glycaemic control. Reductions in HbA1c from baseline were −1.17 ± 0.794%, −1.23 ± 0.896% in cetagliptin 100 mg and 50 mg plus metformin group, respectively. No difference was observed between the cetagliptin 100 mg and 50 mg plus metformin group. Patients with higher baseline HbA1c levels (≥8.5%) experienced greater reductions in HbA1c. A significantly greater proportion of patients achieved an HbA1c <7.0% with cetagliptin 100 mg (49.4%) and cetagliptin 50 mg (51.1%) plus metformin than metformin monotherapy (14.4%). Both combination therapies also improved the homeostasis model assessment β‐function index and decreased systolic blood pressure. There was no increased risk of adverse effects with combination therapy, and both combination therapies were generally well tolerated.ConclusionsThe addition of cetagliptin once daily to metformin was more efficacious and well tolerated than metformin monotherapy in Chinese patients with type 2 diabetes who had inadequate glycaemic control with metformin monotherapy.

01 Jun 2022·British Journal of Clinical PharmacologyQ2 · MEDICINE

A double‐blind, randomized, placebo and positive‐controlled study in healthy volunteers to evaluate pharmacokinetic and pharmacodynamic properties of multiple oral doses of cetagliptin

Q2 · MEDICINE

Article

Author: Shao, Feng ; Tang, Dong ; Lu, Jinmiao ; Ding, Jinsong ; Chen, Juan ; Wang, Lu ; Zhou, Chen ; Tian, Xusheng ; Ding, Juping ; Yu, Qiang ; Xie, Daosheng ; Xie, Lijun ; Zhou, Sufeng ; Wang, Tong

AimsThis study investigated the pharmacokinetics and pharmacodynamics properties, safety and tolerability of cetagliptin.MethodsForty‐eight healthy subjects were enrolled in this study. Three cohorts were investigated in sequential order: 50, 100 and 200 mg cetagliptin. Positive control (sitagliptin 100 mg) was designed as open label. Blood samples were collected and analysed for pharmacokinetic and pharmacodynamic properties. Safety and tolerability were assessed throughout the study.ResultsFollowing multiple oral doses, cetagliptin was rapidly absorbed and reached peak plasma concentrations after approximately 1.0–1.5 hours. Plasma cetagliptin concentrations increased at a rate greater than dose. Accumulation of cetagliptin was modest, and steady state was generally achieved at day 5. Doses ≥50 mg of cetagliptin administered once daily will result in sustained dipeptidyl peptidase‐4 (DPP‐4) inhibition (≥80%). The plasma concentration giving 50% of maximum drug effect of DPP‐4 inhibition for cetagliptin (5.29 ng/mL) was lower than that of sitagliptin (7.03 ng/mL). Active glucagon‐like‐1 peptide (GLP‐1) concentrations were significantly increased in the cetagliptin groups by 2.3‐ to 3.1‐fold at day 1 and 3.1‐ to 3.6‐fold at steady state compared with that of placebo, and active GLP‐1 concentrations were increased with increasing dose. Compared with sitagliptin, doses ≥100 mg once daily of cetagliptin produced postprandial increases in active GLP‐1 level and induced to long‐lasting glucose‐lowering efficacy. Cetagliptin was well tolerated across all doses studied.ConclusionCetagliptin demonstrates the great potential for treatment with type 2 diabetes patients based on the inhibition of DPP‐4, the increase in GLP‐1 and insulin, the decrease in glucose, and might be more effective in DPP‐4 inhibition than sitagliptin.

100 Deals associated with Cetagliptin Phosphate

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	NDA/BLA	CN	Nanjing Healthnice Pharmaceutical Co., Ltd.	02 Feb 2023
Diabetes Mellitus, Type 2	NDA/BLA	CN	CGeneTech (Suzhou, China) Co. Ltd.	02 Feb 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTR20200157 \| CTR20200172 (Corporate Publications) Manual	Phase 3	Diabetes Mellitus, Type 2	1,000	盛格列汀	(ffbueelbgi) = 盛格列汀片50mg剂量组（低剂量组）第24周末糖化血红蛋白（HbA1c）降低值达到主要临床终点，显著优于对照组 eltgqfdcjx (ikauqgqmiv ) View more	Positive	17 Oct 2022

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