达格列净/利格列汀(Dapagliflozin/linagliptin) - 药物靶点：DPP-4 x SGLT2_在研适应症：糖尿病，2型糖尿病_专利_临床

概要

基本信息

药物类型

小分子化药

别名

靶点

DPP-4 x SGLT2

作用方式

抑制剂

作用机制

DPP-4抑制剂(二肽基肽酶IV抑制剂)、SGLT2抑制剂(钠-葡萄糖协同转运蛋白-2抑制剂)

治疗领域

内分泌与代谢疾病

在研适应症

糖尿病2型糖尿病

非在研适应症-

原研机构

Aju Pharm Co. Ltd.

在研机构

Aju Pharm Co. Ltd.

HK inno.N Corp.

非在研机构-

权益机构-

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构/序列

分子式C24H35ClO9

InChIKeyGOADIQFWSVMMRJ-UPGAGZFNSA-N

CAS号960404-48-2

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关联

3

项与达格列净/利格列汀相关的临床试验

NCT06329674

/ Completed临床3期

Evaluate the Efficacy and Safety of the Combination of A51R3 and AJU-A51 Compared With the Combination of A51R3 and A51R2 in Patients With Type 2 Diabetes Mellitus

A multicenter, randomized, double-blind, parallel group, placebo-controlled, phase 3 study to evaluate the efficacy and safety of the combination of A51R3 and AJU-A51 compared with the combination of A51R3 and A51R2 in patients with Type 2 diabetes mellitus who have inadequate glycemic control with the combination of A51R3 and A51R2

开始日期2021-04-27

申办/合作机构

Aju Pharm Co. Ltd.

NCT04972539

/ Completed临床1期

A Randomized, Open, Single-dose, 2x2 Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of A51R1 and A51R2 or Administration of AJU-A51 in Healthy Volunteers Under Fasting Conditions

To evaluate the safety and pharmacokinetic characteristics of AJU-A51 in healthy adults

开始日期2020-08-01

申办/合作机构

Aju Pharm Co. Ltd.

NCT05066516

/ Completed临床1期IIT

An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of IN-C009 in Healthy Subjects

This study was conducted as a randomized, open-label, single-dose, crossover study design. All participants were randomly allocated for group A (Period 1: Individual components (ICs), period 2: FCDP) and group B (Period 1: FCDP, period 2: ICs), and each group was administered either a single dose of IN-C009 (FCDP, dapagliflozin 10mg/linagliptin 5 mg) (HK inno.N., Seoul, Korea) or co-administration of a single dose of dapagliflozin (Forxiga 10 mg, AstraZeneca, Cambridge, England, UK) and linagliptin (Trajenta 5mg, Beringer-Ingelheim, Ingelheim, Germany) after at least 10 hours of overnight fasting. After the 28 days of the washout period, the participants received the opposite treatment (Group A: IN-C009; Group B: dapagliflozin and linagliptin). The dosage of dapagliflozin and linagliptin in the study is commercially used and recommended amount for the control of T2DM currently.
On the day 1 (the day of each drug administration), the serial blood samples were drawn immediately before (0 h) and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, and 72 h (for dapagliflozin), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, and 72 h (for linagliptin) after the each dosing to assess pharmacokinetics of each drugs.

开始日期2020-06-25

申办/合作机构

Korea University Anam Hospital

100 项与达格列净/利格列汀相关的临床结果

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100 项与达格列净/利格列汀相关的转化医学

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100 项与达格列净/利格列汀相关的专利（医药）

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1

项与达格列净/利格列汀相关的文献（医药）

2025-01-01·Diabetes, Obesity and Metabolism

Efficacy and safety of a fixed‐dose combination of dapagliflozin and linagliptin (AJU‐A51) in patients with type 2 diabetes mellitus: A multicentre, randomized, double‐blind, parallel‐group, placebo‐controlled phase III study

Article

作者: Lee, Woo Je ; Shon, Ho Sang ; Kim, Myung Jin ; Min, Kyung Wan ; Lee, Byung‐Wan ; Park, Jung Hwan ; Ku, Bon Jeong ; Kang, Jun Goo ; Kim, Sang Yong ; Hong, Jun Hwa ; Kim, Jae Hyeon ; Kim, Tae Nyun ; Lee, Chang Beom ; Park, Joong‐Yeol ; Won, Jong Chul

AbstractAimsTo evaluate the efficacy and safety of add‐on dapagliflozin in patients with type 2 diabetes mellitus (T2D) who had inadequate glycaemic control with metformin and linagliptin.Materials and MethodsA total of 235 patients with inadequate response to metformin (≥1000 mg/day) plus linagliptin (5 mg/day) were randomized to receive either dapagliflozin/linagliptin fixed‐dose combination (FDC [AJU‐A51]) 10/5 mg/day (n = 117) or linagliptin 5 mg plus placebo (n = 118) for 24 weeks. After the main treatment period, patients who received linagliptin plus placebo were treated with AJU‐A51 for an additional 28 weeks. Change in glycated haemoglobin (HbA1c) from baseline to Week 24 was the primary endpoint.ResultsAJU‐A51 significantly reduced HbA1c levels (from 7.93% ± 0.82% to 7.11% ± 0.61%) compared with linagliptin plus placebo (from 7.80% ± 0.71% to 7.87% ± 0.94%), with a least squares mean difference of −0.88% (95% confidence interval −1.07 to −0.68; p < 0.0001) at 24 weeks. The AJU‐A51 group had a significantly higher proportion of patients who achieved HbA1c <7.0% at Week 24 than the control group (44.8% vs. 18.6%; p < 0.001). The AJU‐A51 group maintained glycaemic efficacy up to 52 weeks, whereas the control group showed a substantial reduction in HbA1c after switching to AJU‐A51 in the extension study period. Both groups had similar incidence of treatment‐emergent and serious adverse events, and no cases of symptomatic hypoglycaemia were reported.ConclusionsDapagliflozin and linagliptin FDC (AJU‐A51) showed potent glucose‐lowering effects, with good tolerability, in patients with T2D who had poor glycaemic control on metformin and linagliptin (ClinicalTrials.gov [NCT06329674]).

100 项与达格列净/利格列汀相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
糖尿病	临床3期	韩国	HK inno.N Corp.	2023-06-01
2型糖尿病	临床3期	韩国	Aju Pharm Co. Ltd.	2021-04-27

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06329674 (Pubmed \| Diabetes Obes Metab) 人工标引	临床3期	2型糖尿病	235	Dapagliflozin/Linagliptin FDC (AJU-A51) 10/5 mg/day	(齋蓋膚廠艱築鑰鏇網鏇) = 構鹹膚築衊鏇廠積蓋獵襯廠簾蓋積築餘壓簾簾 (鏇蓋選鑰鬱簾鹹鑰餘鏇, 0.61) 更多	积极	2024-10-07
				Linagliptin 5 mg plus Placebo	(齋蓋膚廠艱築鑰鏇網鏇) = 簾遞鹹餘願膚淵構餘遞襯廠簾蓋積築餘壓簾簾 (鏇蓋選鑰鬱簾鹹鑰餘鏇, 0.94) 更多
932-P (ADA2024)	临床3期	2型糖尿病	232	Dapagliflozin 10mg-Linagliptin 5mg	餘繭齋製糧壓鏇夢繭蓋(簾鏇築鏇獵鏇襯積淵顧) = 夢積窪憲齋網夢鑰蓋構鹽襯製願糧襯醖淵鹹衊 (範觸窪淵醖齋淵選獵簾, Â±2.29) 更多	积极	2024-06-14
				Linagliptin	範衊積選齋壓築獵構衊(願鏇鹹鹽範鹹構膚餘襯) = 鬱壓蓋範遞獵積廠壓構襯襯構範鹽齋範選製觸 (齋獵淵觸選鑰簾齋鑰鏇 )