盐酸二甲双胍(Metformin Hydrochloride) - 药物靶点：PRKAB1_在研适应症：糖尿病，2型糖尿病，浸润性乳腺癌_专利_临床

概要

基本信息

简介盐酸二甲双胍，商品名为GLUCOPHAGE，用于治疗2型糖尿病。它于1957年在法国首次获批，现在由Bristol Myers Squibb公司生产。GLUCOPHAGE通过激活PRKAB1，帮助改善10岁及以上成人和儿童患者的血糖控制，配合饮食和运动使用。该药物属于双胍类药物，通常用作辅助疗法，帮助管理2型糖尿病患者的血糖水平。

药物类型

小分子化药

别名

Meiformin Hydrochloride、Metformin hydrochloride (JP17/USP)、Metformin Hydrochlorride

+ [67]

靶点

PRKAB1

作用机制

PRKAB1激活剂(腺苷酸活化蛋白激酶亚基β1激活剂)

治疗领域

内分泌与代谢疾病肿瘤血液及淋巴系统疾病+ [11]

在研适应症

糖尿病2型糖尿病浸润性乳腺癌+ [46]

非在研适应症

异戊酸血症获得性免疫缺陷综合征大肠腺癌+ [54]

原研机构

Bristol Myers Squibb Co.

在研机构

National Cancer Institute

Curative Biotechnology, Inc.

Nippon Shinyaku Co., Ltd.

+ [17]

非在研机构

Merck Serono SAMerck Serono International SAMerck KGaA

+ [7]

最高研发阶段批准上市

首次获批日期

中国 (1992-01-01),

2型糖尿病

最高研发阶段(中国)批准上市

特殊审评优先审评 (中国)

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结构

分子式C4H12ClN5

InChIKeyOETHQSJEHLVLGH-UHFFFAOYSA-N

CAS号1115-70-4

关联

1,751

项与盐酸二甲双胍相关的临床试验

CTRI/2024/10/074853 / Not yet recruiting临床4期IIT

Efficacy and safety of Curcuma longa either alone or in combination with metformin on glycemic status in prediabetes population: A Randomized, double-blinded, double-dummy, placebo-controlled, factorial design trial - NIL

开始日期2025-10-15

申办/合作机构-

NCT04836910 / Not yet recruitingN/AIIT

The Change in Microbiome Following Treatment of Women With Polycystic Ovaries

Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder among women in reproductive age with an estimated prevalence of 5% to 19.5%. It is a chronic complex syndrome with psychological (depression and anxiety), reproductive and metabolic abnormalities. The etiology seems to be multifactorial. Lately, interest regarding the association between PCOS women and gut macrobiotic have been emerged. Hyperandrogenism was correlated with those changes in the microbiota which reflects the fact that the microbiome can influence the development and pathology of PCOS .
Therefore, aim of this study is to explore the diversity and alternations of the vaginal and the gut microbiome in patients with PCOS during common therapeutic interventions and connect them to different phenotypes of the syndrome.

开始日期2025-09-01

申办/合作机构

Sheba Medical Center

NCT05607316 / Withdrawn临床2期IIT

Metformin as a Novel Treatment for Vitiligo by Targeting CD8+ T Cell Metabolism

Metformin modulates metabolism in multiple cell types and is currently used to reduce glucose levels and insulin resistance in diabetic patients. The investigators hypothesize that oral metformin can regulate the metabolism of CD8+ T cells, reduce their cytotoxic activity and thus serve as a novel treatment for vitiligo.

开始日期2025-07-01

申办/合作机构

University of Massachusetts

100 项与盐酸二甲双胍相关的临床结果

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100 项与盐酸二甲双胍相关的转化医学

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100 项与盐酸二甲双胍相关的专利（医药）

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1,159

项与盐酸二甲双胍相关的文献（医药）

2025-02-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Proteomics exploration of metformin hydrochloride for diabetic kidney disease treatment via the butanoate metabolism pathway

Article

作者: Wang, Xian ; Qiu, Shi ; Chen, Hongwei ; Zhang, Aihua ; Guo, Sifan ; Xie, Dandan ; Chai, Jinxuan ; Cai, Ying ; Wang, Shiwei ; Hu, Zhencai ; Wang, Zhibo ; Wang, Yan

Diabetic nephropathy (DKD) is a diabetesrelated kidney injury with an increasing incidence every year. Metformin hydrochloride (MET), a cornerstone treatment for glucose lowering, has been widely reported for the treatment of DKD, but the specific molecular mechanisms and potential therapeutic targets still need to be further explored. We used kidney tissues from db/db mice as samples and used proteomics and bioinformatics to analyse the function, distribution and related pathways of differential proteins in DKD, focusing on the assessment of the binding energies of key proteins in the butyrate pathway and drugs at the molecular level, which showed that the expression profiles of differential proteins in kidney tissues were altered after MET treatment, involving energy metabolism. The key proteins involved in the butanoate metabolism pathway, including AACS, ACSM3, EHHADH and HMGCS2, exhibit binding energies to MET of ＜-5 kcal. It is therefore plausible that MET treatment may affect the butanoate metabolism pathway, potentially ameliorating the progression of DKD by modulating mitochondrial function and inflammatory responses.

2024-12-31·RENAL FAILURE

Identification of kidney-related medications using AI from self-captured pill images

Article

作者: Barreto, Erin F. ; Cheungpasitporn, Wisit ; Sheikh, Mohammad S. ; Suppadungsuk, Supawadee ; Qureshi, Fawad ; Miao, Jing ; Thongprayoon, Charat ; Kashani, Kianoush B. ; Mao, Michael A. ; Pham, Justin H. ; Dreesman, Benjamin ; Craici, Iasmina M.

INTRODUCTION:

ChatGPT, a state-of-the-art large language model, has shown potential in analyzing images and providing accurate information. This study aimed to explore ChatGPT-4 as a tool for identifying commonly prescribed nephrology medications across different versions and testing dates.

METHODS:

25 nephrology medications were obtained from an institutional pharmacy. High-quality images of each medication were captured using an iPhone 13 Pro Max and uploaded to ChatGPT-4 with the query, 'What is this medication?' The accuracy of ChatGPT-4's responses was assessed for medication name, dosage, and imprint. The process was repeated after 2 weeks to evaluate consistency across different versions, including GPT-4, GPT-4 Legacy, and GPT-4.Ø.

RESULTS:

ChatGPT-4 correctly identified 22 out of 25 (88%) medications across all versions. However, it misidentified Hydrochlorothiazide, Nifedipine, and Spironolactone due to misreading imprints. For instance, Nifedipine ER 90 mg was mistaken for Metformin Hydrochloride ER 500 mg because 'NF 06' was misread as 'NF 05'. Hydrochlorothiazide 50 mg was confused with the 25 mg version due to imprint errors, and Spironolactone 25 mg was misidentified as Naproxen Sodium or Diclofenac Sodium. Despite these errors, ChatGPT-4 showed 100% consistency when retested, correcting misidentifications after receiving feedback on the correct imprints.

CONCLUSION:

ChatGPT-4 shows strong potential in identifying nephrology medications from self-captured images, though challenges with difficult-to-read imprints remain. Providing feedback improved accuracy, suggesting ChatGPT-4 could be a valuable tool in digital health for medication identification. Future research should enhance the model's ability to distinguish similar imprints and explore broader integration into digital health platforms.

2024-12-01·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Nitrosamine mitigation: NDMA impurity formation and its inhibition in metformin hydrochloride tablets

Article

作者: Shaklah, Maha ; Faustino, Patrick J ; Mokbel, Alaa ; Alsharif, Fahd M. ; Li, David ; Alsharif, Fahd M ; Wang, Jiang ; Keire, David ; Shakleya, Diaa ; Vera, Matthew ; Alayoubi, Alaadin ; Sayeed, Vilayat A ; O’ Connor, Thomas ; Desai, Saaniya ; Faustino, Patrick J. ; Raw, Andre ; Abrigo, Nicolas ; Mohammad, Adil ; O' Connor, Thomas ; Ashraf, Muhammad ; Sayeed, Vilayat A. ; Essandoh, Martha ; Brown, Dustin

The mitigation of nitrosamine formation in drug products has been studied and approaches such as using formulations with pH modifiers and antioxidants have been shown to decrease the formation of nitrosamines. However, more studies are needed to explore the effectivness of mitigation strategies with different drug models and formulations. The primary objective of this work was to assess the role of different antioxidants and pH modifiers in tablet formulations to mitigate the formation of NDMA, prepared in-house, using metformin hydrochloride as a model drug. A study design for manufacturing metformin hydrochloride formulations was created to evaluate potential mitigation stratigies. The formulations were prepared by wet granulation that included a sodium nitrite spike and various antioxidants such as ascorbic acid, caffeic acid and ferulic acid at various concentrations that may inhibit nitrosamine formation. The study design also included pH modifiers such as hydrochloric acid and sodium carbonate. The metformin hydrochloride formulations were placed under stability conditions that included humidity, temperature and time over a six month period. NDMA inhibition was found to be most effective in formulations with basic pH, followed by the addition of tested antioxidants with 0.1% concentrations in the formulations. All tested antioxidants showed complete mitigation in formulations with 0.5% and 1% concentrations. In summary, basic pH and the inclusion of antioxidants exhibited the potential to mitigate the formation of NDMA in metformin hydrochloride tablets.

697

项与盐酸二甲双胍相关的新闻（医药）

2025-01-09

·drugs

Oral Glucose-Lowering Agents Potential Alternatives to Insulin for Gestational Diabetes

THURSDAY, Jan. 9, 2025 -- With respect to the proportion of infants born large for gestational age, treatment of gestational diabetes with metformin and glyburide , if needed, does not meet the criteria for noninferiority versus insulin, according to a study published online Jan. 6 in the Journal of the American Medical Association . Doortje Rademaker, M.D., from the Amsterdam University Medical Center, and colleagues examined whether a treatment strategy of oral glucose-lowering agents is noninferior to insulin for prevention of large-for-gestational-age infants in a randomized trial conducted at 25 Dutch centers. A total of 820 individuals with gestational diabetes and singleton pregnancies between 16 and 34 weeks of gestation, with insufficient glycemic control after two weeks of dietary changes, were randomly assigned to receive metformin or insulin (409 and 411 participants, respectively). Glyburide was added to metformin, and if needed to achieve glucose targets, insulin was then substituted for glyburide. Overall, 79 percent of the participants randomly assigned to oral agents maintained glycemic control without insulin. The researchers found that 23.9 and 19.9 percent of infants were large for gestational age with oral agents and insulin, respectively (absolute risk difference, 4.0 percent; 95 percent confidence interval, −1.7 to 9.8 percent; P = 0.09 for noninferiority), with the confidence interval exceeding the absolute noninferiority margin of 8 percent. "These findings contribute to existing trial data regarding the use of metformin and glyburide as alternatives for insulin to manage gestational diabetes," the authors write. Several authors disclosed ties to the pharmaceutical industry.

临床结果AHA会议

2025-01-07

·echemi

Eli Lilly’s New Drug Mounjaro Launched on January 2, Approved for Two Indications

Eli Lilly announced on January 2 that its innovative drug Mounjaro (tirzepatide injection) has officially launched in the Chinese market and has received approval for two indications. The drug is suitable for the following two categories of adult patients: first, those with type 2 diabetes who, despite receiving treatment with metformin and/or sulfonylureas, still have unsatisfactory blood sugar control based on diet control and exercise; second, those who, based on diet control and increased exercise, have an initial Body Mass Index (BMI) of 28 kg/m² (obese) or 24 kg/m² (overweight) and have at least one weight-related comorbidity (such as hypertension, dyslipidemia, hyperglycemia, obstructive sleep apnea, cardiovascular disease, etc.) for long-term weight management. In addition, Eli Lilly has submitted a request to the court to join the lawsuit opposing the compound pharmacy's action against the U.S. Food and Drug Administration (FDA). Previously, the FDA determined that Eli Lilly's key drug components were no longer facing supply shortages. Eli Lilly stated that it decided to join the lawsuit because it could not ensure the FDA would adequately represent its interests in this case. The lawsuit involves cheaper versions of Eli Lilly's weight loss drug Zepbound and diabetes drug Mounjaro, both of which contain the same active ingredient, tirzepatide. The FDA announced in October that the supply shortage issue for tirzepatide has been resolved.

上市批准专利侵权

2025-01-02

·drugs

Late Eating Tied to Poor Glucose Tolerance

THURSDAY, Jan. 2, 2025 -- Late consumption of calories is associated with worse glucose tolerance, according to a study published online Oct. 25 in Nutrition & Diabetes . Diana A. Díaz-Rizzolo, Ph.D., R.D., from the Columbia University Irving Medical Center in New York City, and colleagues investigated the impact of habitual late calorie intake (≥45 percent daily calories consumed after 5 p.m.) on glucose metabolism in 26 adults with overweight or obesity and diet- or metformin-controlled prediabetes or type 2 diabetes. The researchers found that early and late eaters did not differ in anthropometrics or daily energy intake, but late eaters consumed more carbohydrates and fats after 5 p.m. There were no differences in fasting glucose, insulin, or C-peptide between groups but late eaters exhibited higher glucose concentrations after an oral glucose tolerance test when adjusting for body weight, fat mass, energy intake, and diet composition. When participants with type 2 diabetes were excluded, glucose results remained. Differences in glucose concentrations were higher in late eaters for time 30 and 60 minutes, when adjusting for diabetes status. "Late eating is associated with greater consumption of calories mostly from carbohydrates and fats and may lead to prolonged evening postprandial glucose excursions contributing to worse glucose tolerance," the authors write. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

100 项与盐酸二甲双胍相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00944	盐酸二甲双胍	A10BA02	DBSALT000114

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
糖尿病	美国	Andrx Labs LLC	2004-04-27
2型糖尿病	中国	安康正大制药有限公司	1992-01-01

未上市

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
浸润性乳腺癌	临床3期	美国	National Cancer Institute	2024-12-16
中性粒细胞减少	临床3期	美国	National Cancer Institute	2024-12-16
阿尔茨海默症	临床3期	美国	National Institute on Aging	2021-03-22
轻度认知障碍	临床3期	美国	National Institute on Aging	2021-03-22
慢性病	临床3期	美国	National Institute on Aging	2020-07-29
胰岛素抵抗	临床3期	美国	National Institute on Aging	2020-07-29
获得性免疫缺陷综合征	临床3期	美国	Merck Sharp & Dohme Corp.	2019-02-01
非典型增生	临床3期	美国	National Cancer Institute	2015-11-23
乳腺增生	临床3期	美国	National Cancer Institute	2015-11-23
非浸润性导管内癌	临床3期	美国	National Cancer Institute	2015-11-23

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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


NCT03746106 (CTgov)	临床4期	硫胺素缺乏症	7	Thiamine (Thiamine Alone)	餘繭窪選鏇餘蓋糧鹽餘(獵醖鑰範醖壓範構蓋蓋) = 構範糧廠襯觸繭鹹壓遞窪糧簾願糧襯範窪鏇選 (衊築糧範簾獵築獵夢壓, 製簾鹹繭襯糧範積壓憲 ~ 淵獵顧夢蓋廠簾衊艱製) 更多	-	2025-01-03
				Thiamine+Trimethoprim (Thiamine Co-administered With Trimethoprim)	餘繭窪選鏇餘蓋糧鹽餘(獵醖鑰範醖壓範構蓋蓋) = 蓋觸襯鬱鑰範醖壓鹹觸窪糧簾願糧襯範窪鏇選 (衊築糧範簾獵築獵夢壓, 選積獵願簾構淵衊衊鹹 ~ 鏇衊觸簾鏇鹹廠壓醖簾) 更多
NCT03029702 (MATCh-GDM, CTgov)	临床4期	妊娠期糖尿病 \| 糖尿病患者妊娠	54	Insulin+Metformin+Glyburide (Usual Care)	顧蓋襯獵醖鬱醖鬱獵獵(餘膚鏇餘製廠廠鹹築繭) = 鏇夢網窪鑰網製鏇淵襯襯醖選積衊簾選遞蓋積 (獵積廠淵顧衊製膚顧簾, 鏇顧遞艱壓襯繭鬱衊範 ~ 積網膚鹽鑰鑰遞窪糧齋) 更多	-	2024-11-29
				Insulin+Metformin+Glyburide (Individualized Treatment)	顧蓋襯獵醖鬱醖鬱獵獵(餘膚鏇餘製廠廠鹹築繭) = 醖築膚廠蓋觸網製廠範襯醖選積衊簾選遞蓋積 (獵積廠淵顧衊製膚顧簾, 壓簾艱觸窪淵艱衊夢簾 ~ 鏇繭糧遞鹽憲齋繭糧鹽) 更多
Literature 人工标引	N/A	哮喘	-	metformin	繭獵構鬱膚遞願鏇願窪(醖選選壓膚襯繭網鹽壓) = Metformin was found to be associated with fewer asthma attacks of similar magnitude in both approaches (SCCS: IRR, 0.68; 95% CI, 0.62-0.75; IPTW: HR, 0.76; 95% CI, 0.67-0.85). Negative control analyses did not find evidence of significant bias. 憲願製艱構獵築積糧簾 (淵夢簾廠窪夢積糧鹽顧 )	积极	2024-11-18
971 (SITC2024)	N/A	肺癌 \| 肥胖新辅助	756	Metformin users	糧鏇鑰膚鏇醖壓選窪鏇(壓繭衊齋鏇壓選範憲夢): HR = 0.53 (95% CI, 0.28 ~ 1.0), P-Value = 0.049	积极	2024-11-05
				Metformin (Obese/Overweight patients (BMI ≥ 25))
NCT03617458 (CTgov)	临床2期	肺动脉高压 \| 胰岛素抵抗	73	mHealth Intervention+metformin (Metformin + mHealth Intervention)	襯範構積廠簾選窪鑰願(築鏇築遞餘構夢糧鏇鬱) = 憲簾繭鏇簾獵鹽製觸廠艱醖艱簾夢膚鹽願觸餘 (選餘齋夢糧網願鹹鹽鏇, 窪餘鑰齋膚製淵繭選壓 ~ 願膚築簾衊鏇願構構鹽) 更多	-	2024-10-16
				Usual Care (Placebo + Usual Care)	襯範構積廠簾選窪鑰願(築鏇築遞餘構夢糧鏇鬱) = 繭醖憲觸糧範膚鹹鹹積艱醖艱簾夢膚鹽願觸餘 (選餘齋夢糧網願鹹鹽鏇, 簾築構鏇繭鹽鹽膚夢網 ~ 簾鹽繭鏇醖窪鹽獵餘遞) 更多
NCT04998032 (EASD2024) 人工标引	临床2期	2型糖尿病	120	Efsubaglutide Alfa 1 mg + metformin	襯範積膚網遞淵積範蓋(襯範鬱鬱淵齋膚廠淵積) = 顧簾網衊醖齋糧繭鑰築繭鏇遞選鬱築鏇繭蓋範 (餘餘鬱鏇艱膚糧餘範淵, -1.38 ~ -0.82) 更多	积极	2024-09-09
				Efsubaglutide Alfa 3 mg + metformin	襯範積膚網遞淵積範蓋(襯範鬱鬱淵齋膚廠淵積) = 積鹽網醖遞構築顧廠簾繭鏇遞選鬱築鏇繭蓋範 (餘餘鬱鏇艱膚糧餘範淵, -1.70 ~ -1.16) 更多
NCT03800602 (Phase II trial of nivolumab and metformin, CTgov)	临床2期	大肠腺癌 \| 异戊酸血症 \| 难治性结直肠癌 ... 更多	29	nivolumab+Metformin	顧選鹽鏇廠鹹鑰襯繭獵(淵繭簾鬱夢觸鏇獵簾廠) = 製衊廠膚憲簾鹹夢淵鏇製繭窪餘齋鏇鬱獵鹽願 (構鏇觸鏇構窪壓獵網簾, 憲糧願淵廠簾壓蓋餘顧 ~ 醖積築鏇餘願願餘築餘) 更多	-	2024-09-05
NCT02980276 (EMERGE, Pubmed \| Diabetologia) 人工标引	临床3期	妊娠期糖尿病	-	Metformin	醖鹽蓋齋築鏇顧製獵鹹(鹹淵鬱繭壓憲醖製醖蓋) = 鹽壓餘鬱製衊構憲遞積艱鏇艱憲鏇鹹選鏇觸襯 (網夢範鑰衊獵網鏇願鏇 ) 更多	积极	2024-08-31
				Placebo	醖鹽蓋齋築鏇顧製獵鹹(鹹淵鬱繭壓憲醖製醖蓋) = 壓觸鹹網網餘繭艱淵窪艱鏇艱憲鏇鹹選鏇觸襯 (網夢範鑰衊獵網鏇願鏇 ) 更多
ESC2024	N/A	肿瘤	-	Metformin users	廠構遞蓋鑰顧鑰膚廠衊(醖選觸衊簾願築網網簾): HR = 1.92 (95% CI, 1.78 ~ 2.08) 更多	积极	2024-08-31
				Sulphonylurea users
Pubmed 人工标引	N/A	多囊卵巢综合征 GDF-15	24	metformin	膚繭遞窪窪襯鹽簾齋製(蓋簾衊壓壓餘糧壓艱憲): P-Value = 0.007	积极	2024-08-27
				Placebo