The goal of this observational study is to compare severity and mortality rates of acute cerebral infarction(requiring thrombolysis or endovascular recanalization) depending on the type of oral antidiabetic drug taken before the onset of cerebral infarction.
Researchers will compare the group that used DPP-4 inhibitors as anti-diabetic drugs before cerebral infarction and the group that did not use them to see the effect of DPP-4 inhibitors in reducing severity of cerebral infarction.

开始日期2023-08-01

申办/合作机构

Ajou University

[+1]

NCT05918094 / Recruiting临床3期IIT

Comparing Modified XELOX Plus Sintilimab With Standard XELOX Plus Sintilimab in First-line Treatment for HER2-negative Gastric/Gastroesophageal Junction Adenocarcinoma

This is a randomized, controlled, multicenter phase Ⅲ study to evaluate the therapeutic efficacy of modified XELOX plus sintilimab versus standard XELOX plus sintilimab in subjects with advanced HER2-negative gastric or gastroesophageal adenocarcinoma in the first-line treatment. The primary outcome is the progression-free survival (PFS), with a planned enrollment of 540 subjects.

开始日期2023-04-30

申办/合作机构

中山大学

NCT05143177 / Recruiting临床2/3期

An Adaptive Phase 2/3 Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel, 3 Arm Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease With Mild to Moderate Aortic Stenosis (EVOID-AS)

This is an adaptive Phase 2/3 multicenter, double-blind, placebo-controlled, randomized, parallel, 3 arm study to evaluate the efficacy and safety of DA-1229 compared to placebo in patients with calcific aortic valve disease with mild to moderate aortic stenosis. There are 3 arms in this study to which patients will be randomized in a ratio of 1:1:1 to receive the DA-1229 or placebo orally once daily for a period of 104 weeks . the 3 arms are: placebo, DA-1229 5mg GroupDA-1229 10 mg Group.
The study will have three phases: Screening Period (up to 4 weeks), Treatment Period (104 weeks), and Follow-Up Period (2-4 weeks). Total Study Duration is112 Weeks.

开始日期2022-06-27

申办/合作机构

Rednvia Co. Ltd.

100 项与依沃格列汀相关的临床结果

登录后查看更多信息

100 项与依沃格列汀相关的转化医学

登录后查看更多信息

100 项与依沃格列汀相关的专利（医药）

登录后查看更多信息

项与依沃格列汀相关的文献（医药）

2023-10-26·Pharmaceuticals (Basel, Switzerland)

The Effect of Compression Pressure on the First Layer Surface Roughness and Delamination of Metformin and Evogliptin Bilayer and Trilayer Tablets.

Article

作者: Sun Ho Kim ; Jung Han Kook ; Dong-Wan Seo ; Myung Joo Kang

The objectives of this study were to evaluate the delamination of convex-shaped metformin HCl (MF) and evogliptin tartrate (EG) multi-layer tablets depending on the pre-compression and main compression pressures and simultaneously correlate these results with those of a surface roughness analysis. Free-flowing MF and EG (median diameters of 38.3 and 44.7 μm, respectively) granules prepared using the wet granulation method were pre-compressed and subsequently compressed into bilayer and trilayer tablets using a universal testing machine. The compaction force required to break the tablets increased linearly as the main compression pressure increased (30-150 MPa). Conversely, the interfacial strength and compaction breaking force decreased as the pre-compression pressure increased (10-110 MPa). A surface roughness analysis employing a profilometer revealed that the first layer (MF) roughness drastically decreased from 5.89 to 0.51 μm (Ra, arithmetic average of profile height deviations from the mean line) as the pre-compression pressure increased from 10 to 150 MPa in the bilayer tablet. Accordingly, the decrease in the roughness of the first layer reduced the inter-penetration at the interface, as observed via energy dispersive spectrometer (EDS)-equipped scanning electron microscopy, decreasing the interfacial bonding strength and causing delamination of the MF/EG multi-layer tablets. These findings indicate the significance of roughness control in the actual preparation of multi-layer tablets and the usefulness of profilometer- and EDS-based surface analyses for interpreting the delamination of multi-layer tablets.

2023-09-26·Diabetes & metabolism journal

Efficacy and Safety of Evogliptin Add-on Therapy to Dapagliflozin/Metformin Combinations in Patients with Poorly Controlled Type 2 Diabetes Mellitus: A 24-Week Multicenter Randomized Placebo-Controlled Parallel-Design Phase-3 Trial with a 28-Week Extension.

Article

作者: Jun Sung Moon ; Il Rae Park ; Hae Jin Kim ; Choon Hee Chung ; Kyu Chang Won ; Kyung Ah Han ; Cheol-Young Park ; Jong Chul Won ; Dong Jun Kim ; Gwan Pyo Koh ; Eun Sook Kim ; Jae Myung Yu ; Eun-Gyoung Hong ; Chang Beom Lee ; Kun-Ho Yoon

Background:

This study investigates the long-term efficacy and safety of evogliptin add-on therapy in patients with inadequately controlled type 2 diabetes mellitus (T2DM) previously received dapagliflozin and metformin (DAPA/MET) combination.

Methods:

In this multicenter randomized placebo-controlled phase 3 trial, patients with glycosylated hemoglobin (HbA1c) levels 7.0% to 10.5% (n=283) previously used DAPA 10 mg plus MET (≥1,000 mg) were randomly assigned to the evogliptin 5 mg once daily or placebo group (1:1). The primary endpoint was the difference in the HbA1c level from baseline at week 24, and exploratory endpoints included the efficacy and safety of evogliptin over 52 weeks (trial registration: ClinicalTrials.gov NCT04170998).

Results:

Evogliptin add-on to DAPA/MET therapy was superior in HbA1c reduction compared to placebo at weeks 24 and 52 (least square [LS] mean difference, -0.65% and -0.55%; 95% confidence interval [CI], -0.79 to -0.51 and -0.71 to -0.39; P<0.0001). The proportion of patients achieving HbA1c <7% was higher in the triple combination group at week 52 (32.14% vs. 8.51% in placebo; odds ratio, 5.62; P<0.0001). Evogliptin significantly reduced the fasting glucose levels and mean daily glucose levels with improvement in homeostatic model assessment of β-cell function (LS mean difference, 9.04; 95% CI, 1.86 to 16.21; P=0.0138). Adverse events were similar between the groups, and no serious adverse drug reactions were reported in the evogliptin group. Conclusion: Long-term triple combination with evogliptin added to DAPA/MET showed superior HbA1c reduction and glycemic control compared to placebo at 52 weeks and was well tolerated.

2023-08-02·Journal of AOAC International

Stability-Indicating Densitometric Analysis of Evogliptin Tartrate in Bulk and Tablet Dosage Form.

Article

作者: Shruti Srivastava ; Suneela Dhaneshwar ; Neha Kawathekar

BACKGROUND:

Evogliptin tartrate is a novel dipeptidyl peptidase (DPP-4) inhibitor very recently introduced into the market as an oral hypoglycemic drug.

OBJECTIVE:

The literature review has revealed no reports of stability-indicating analytical methods so far for evogliptin tartrate. So, the goal of this study was to develop and validate a stability indicating HPTLC method for evogliptin tartrate in bulk and tablet dosage form.

METHOD:

For the study pre-coated plates of silica gel 60F254 were utilized as stationary phase and acetonitrile: water: formic acid (30:8:2; v/v/v) was used as a developing system. The densitometric scanning was performed at 270 nm and the method was validated as per ICH guidelines for accuracy, precision, LOD and LOQ. Evogliptin was subjected to forced degradation studies and was exposed to various stress conditions like acid/base hydrolysis, oxidation, thermal stress, and UV light.

RESULTS:

The developed method furnished compact spots of evogliptin (Rf 0.62 ± 0.05) and was linear in the concentration range of 1-5 µg/spot. The lowest detection and quantitation values were found to be 0.331 and 1.003 µg/spot respectively and % recovery was found to be 101.09. The low RSD values (below 2%) for intra-day (% RSD 1.86) and inter-day (% RSD 1.43) precision studies demonstrated the preciseness of the developed method.

CONCLUSION:

All the validation parameters were found to be within the acceptable range prescribed by ICH guidelines indicating that the developed method was accurate, precise, selective, and reproducible. A total of five degradation products were resolved under various stress conditions.

HIGHLIGHTS:

The proposed method has a promising application commercially for identification, routine quantitative determination, and monitoring of stability of the evogliptin tartrate in bulk and tablet dosage forms to guarantee its safety, efficacy, and quality. Moreover, the developed method will also help in formulation development and in determining the appropriate storage conditions.

项与依沃格列汀相关的新闻（医药）

2022-09-06

·BioSpace

Dong-A ST and Beactica Therapeutics mutually agree to conclude oncology collaboration

UPPSALA, Sweden, Sept. 6, 2022 /PRNewswire/ -- Dong-A ST Co., Ltd. (170900: Korea SE), a Korean pharmaceutical company, and Beactica Therapeutics AB, a Swedish precision oncology company, today announced that they have mutually agreed to terminate their collaboration and licensing agreement. The collaboration focused on developing novel candidate compounds against multiple cancer targets of mutual interest. The partnership has been productive, and multiple compound classes are now in various stages of lead generation and optimization. As part of the termination, both Dong-A ST and Beactica Therapeutics will gain exclusive global rights for further development and commercialization for different compounds series developed during the collaboration. No obligations to pay milestone payments or royalties will remain for the assets divided between Dong-A and Beactica. For a limited time, each company is entitled to a revenue share from any related future outlicensing activities by the other party. Full financial details remain undisclosed. "We appreciate the opportunity we have had to collaborate with Beactica Therapeutics over the past five years. Our combined efforts have led to important breakthroughs," said Dr Jae-Hong Park, President and CSO of Dong-A ST. "We will continue to share with Beactica the ambition to make a clinical impact where it is urgently needed." "We have valued the partnership with Dong-A and are pleased by what we have achieved together. Gaining exclusive global rights to certain compounds is perfectly aligned with Beactica's ambition to itself become a clinical-stage precision oncology company," said Dr Per Källblad, CEO of Beactica Therapeutics. "We are excited to now add these assets to our pipeline as wholly-owned programmes." The collaboration between Dong-A ST and Beactica Therapeutics was initiated in October 2016 and expanded in December 2018. In December 2019, a key milestone was achieved. About Dong-A ST Dong-A ST Co., Ltd. specializes in the discovery, development, manufacture and markets pharmaceutical products and medical devices worldwide. The company offers various prescription drugs, including Stillen (Gastritis 2002); Zydena (Erectile dysfunction , 2005); Motilitone (Functional dyspepsia, 2011); Suganon (TZDM, 2016) as well as biologics and biosimilar products. Once-daily IV/oral Sivextro (Tedizolid, ABSSSI) was also developed by Dong-A ST which was approved by US FDA and launched in US (2014) and EU (2015) by global partners. Dong-A ST has a strong oncology R&D division with immuno-oncology and epigenetic pipeline. Dong-A ST Co., Ltd. was founded in 1932 and is headquartered in Seoul, South Korea. It is listed on the Korean stock exchange. For more information, visit . About Beactica Therapeutics Beactica Therapeutics AB is a precision oncology company committed to the fight against cancer. The company is advancing a pipeline of novel small molecule therapeutics to treat genetically defined cancers with significant unmet clinical need. Beactica's approach is centered around targeting disease proteins with synthetic lethality vulnerabilities by applying its molecular interaction-based drug discovery engine to generate novel small molecule across synergistic modalities, including allosteric modulators and targeted protein degraders (PROTACs). Beactica deliver value to patients and shareholders by advancing its programmes into early clinical trials. For more information on Beactica Therapeutics, please visit . Dong-A ST Co., Ltd. Contact Hannah Lee R&BD Team e2191946@donga.co.kr Tel: +82 31 260 5833 Beactica Therapeutics AB Contact Per Källblad M.Sc. Ph.D. CEO per.kallblad@beactica.com Tel: +46 18 56 08 80 This information was brought to you by Cision The following files are available for download: View original content: SOURCE Beactica Therapeutics AB

蛋白降解靶向嵌合体生物类似药小分子药物合作

100 项与依沃格列汀相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11023	依沃格列汀	A10BH07	DB12625

研发状态

适应症	最高研发状态	国家/地区	公司
2型糖尿病	批准上市	印度更多	Alkem Laboratories Ltd. 更多
主动脉瓣狭窄	临床2期	韩国更多	Dong-A ST Co., Ltd. 更多
二叶式主动脉瓣疾病	临床2期	韩国更多	Dong-A ST Co., Ltd. 更多
非酒精性脂肪性肝炎	临床前	韩国更多	Dong-A ST Co., Ltd. 更多
肾脏疾病	无进展	韩国更多	Dong-A ST Co., Ltd. 更多

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02949193 (Pubmed \| Diabetes Obes Metab) 人工标引	临床3期	2型糖尿病	222	evogliptin	(觸鹽窪糧遞築簾簾遞鹽) = 鬱襯獵廠獵遞醖鑰廠遞膚蓋艱蓋醖餘廠網蓋製 (艱鏇衊鬱遞廠餘遞醖獵 ) 更多	非劣	2017-05-01
				sitagliptin	(觸鹽窪糧遞築簾簾遞鹽) = 蓋糧築膚壓鑰觸憲顧窪膚蓋艱蓋醖餘廠網蓋製 (艱鏇衊鬱遞廠餘遞醖獵 ) 更多
NCT00961025 (Pubmed \| Med Lett Drugs Ther)	临床1期	-	-	DA-1229	(製願齋醖遞蓋遞構網築) = Twenty-one adverse events were reported; all were mild, and all subjects recovered spontaneously 艱構鑰製觸壓積範鏇壓 (淵憲積膚製網廠廠窪蓋 )	-	2012-09-01
NCT02946541 (Pubmed) 人工标引	临床3期	2型糖尿病	160	evogliptin	(襯觸製憲窪觸鑰鹽鑰襯) = 齋醖夢範蓋構淵網積齋醖鏇簾淵艱獵艱艱選廠 (範願齋艱築鹹醖積鑰齋 ) 更多	积极	2017-12-01
				Placebo	(襯觸製憲窪觸鑰鹽鑰襯) = 鏇鑰遞繭襯觸範夢網簾醖鏇簾淵艱獵艱艱選廠 (範願齋艱築鹹醖積鑰齋 ) 更多