格列美脲/盐酸二甲双胍(Glimepiride/Metformin Hydrochloride) - 药物靶点：KATP channels x PRKAB1 x SUR_在研适应症：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

Amaryl M、Glimepiride/metformin、Metformin/glimepiride

+ [3]

靶点

KATP channels x PRKAB1 x SUR

作用方式

阻滞剂、激活剂、调节剂

作用机制

KATP通道阻滞剂、PRKAB1激活剂(腺苷酸活化蛋白激酶亚基β1激活剂)、SUR调节剂(磺酰脲受体调节剂)

治疗领域

内分泌与代谢疾病

在研适应症

2型糖尿病

非在研适应症-

原研机构

Sanofi

在研机构

Sanofi

非在研机构-

最高研发阶段批准上市

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C4H12ClN5

InChIKeyOETHQSJEHLVLGH-UHFFFAOYSA-N

CAS号1115-70-4

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关联

21

项与格列美脲/盐酸二甲双胍相关的临床试验

NCT06759922

/ Recruiting临床4期IIT

Clinical Efficacy and Safety of Glimepiride, Empagliflozin and Sitagliptin With Metformin in Type 2 Diabetes Mellitus: A Double and Triple Drug Therapy

This clinical trial aims to evaluate and compare the clinical efficacy and safety of Glimepiride, Empagliflozin, and Sitagliptin with Metformin in newly diagnosed Type 2 Diabetes Mellitus patients.
The study will involve 172 participants, aged 30-55, enrolled at the National Medical Centre, Karachi, Pakistan. The study involves four groups, subjects will receive following treatment: Group A will receive Tab Metforrmin 500mg + Tab Glimepiride 2mg (FDC) , Group B Tab Metforrmin 500mg + Tab Empagliflozin 12.5mg (FDC), Group C Tab Metforrmin 500mg + Tab Sitagliptin 50mg (FDC) and Group D Tab Metformin 500mg + Tab Empagliflozin 12.5mg (FDC) + Tab Sitagliptin 50mg per orally, once daily for 90 days. Safety and efficacy will be assessed through anthropometric measurements and lab investigations at baseline, 6 weeks, and 12 weeks, with weekly monitoring of blood sugar levels. The total duration of the study will be 6 months, with a 3-month individual treatment period.

开始日期2025-01-01

申办/合作机构

Bahria University

CTR20190757

/ CompletedN/A

格列美脲二甲双胍片在健康受试者中随机、开放、单剂量、两周期、两交叉空腹和餐后状态下的生物等效性研究

主要目的：以法国赛诺菲-万安特公司生产Amaryl®M为参比制剂，对比华中药业生产的格列美脲二甲双胍片（受试制剂），考察健康志愿者单次口服格列美脲二甲双胍片在人体的血药浓度及主要药代动力学参数，并评价其生物等效性。次要目的：观察格列美脲二甲双胍片（受试制剂）和格列美脲二甲双胍片（参比制剂）在健康受试者中的安全性。

开始日期2019-04-25

申办/合作机构

华中药业股份有限公司

NCT02395237

/ Withdrawn临床1期IIT

An Open-label, Randomized, Two-treatment Crossover Bioequivalence Study Comparing Two Batches of the Same Fixed Dose Combinations Amaryl® M IR 2/1000 (Glimepiride/Metformin Hydrochloride Immediate Release Combination Tablet) in Fed Conditions in Healthy Male and/or Female Subjects.

The purpose of this study is to assess, after single oral administration under fed conditions, the bioequivalence between the two batches of the same glimepiride/metformin hydrochloride (HCl) 2 mg/1000 mg fixed dose combination (FDC) tablets (immediate release combination tablet Amaryl® M IR 2/1000) manufactured in India and in Turkey.

开始日期2015-05-01

申办/合作机构

Pharmaceutical Research Unit, Jordan

[+1]

100 项与格列美脲/盐酸二甲双胍相关的临床结果

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100 项与格列美脲/盐酸二甲双胍相关的转化医学

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100 项与格列美脲/盐酸二甲双胍相关的专利（医药）

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2

项与格列美脲/盐酸二甲双胍相关的文献（医药）

2014-11-01·Journal of Diabetes Investigation3区 · 医学

Efficacy of glimepiride/metformin fixed‐dose combination vs metformin uptitration in type 2 diabetic patients inadequately controlled on low‐dose metformin monotherapy: A randomized, open label, parallel group, multicenter study in Korea

3区 · 医学

ArticleOA

作者: Choi, Dong‐seop ; Kim, Dong‐lim ; Park, Tae Sun ; Chung, Choon Hee ; Cha, Bong‐soo ; Kim, Kyoung‐ah ; Park, Jeong‐hyun ; Jang, Hak Chul ; Kim, Doo‐man ; Kim, Hye‐soon

AbstractAims/IntroductionTo compare the efficacy and safety of early combination therapy with glimepiride/metformin to metformin uptitration in reducing glycated hemoglobin (HbA1c) levels in Korean type 2 diabetic patients inadequately controlled on low‐dose metformin monotherapy.Materials and MethodsIn a randomized, open label, parallel group, multicenter study, 209 Korean type 2 diabetic patients (HbA1c 7.0–10.0%, on metformin 500–1,000 mg/day) received glimepiride/metformin fixed‐dose combination (G/M FDC) or metformin uptitration treatment (Met UP). The primary end‐point was the change in HbA1c from baseline to week 24.ResultsG/M FDC therapy provided significantly greater adjusted mean decreases vs Met UP therapy in HbA1c (−1.2 vs −0.8%, P < 0.0001), and fasting plasma glucose (−35.7 vs −18.6 mg/dL, P < 0.0001). A significantly greater proportion of patients with G/M FDC therapy achieved HbA1c < 7% (74.7 vs 46.6%, P < 0.0001) at the end of the study. More patients experienced hypoglycemia with G/M FDC therapy compared with Met UP therapy (41 vs 5.6%, P < 0.0001), but there was no serious hypoglycemia in any group. A modest increase in mean bodyweight occurred in the patients who were treated with G/M FDC therapy (1.0 kg), whereas a slight decrease was observed in the patients who were treated with Met UP therapy (−0.7 kg).ConclusionThe present study showed that glimepiride/metformin fixed‐dose combination therapy was more effective in glycemic control than metformin uptitration, and was well tolerated in type 2 diabetic patients inadequately controlled by low‐dose metformin monotherapy in Korea. This trial was registered with ClinicalTrial.gov (no. NCT00612144).

2014-11-01·Pakistan journal of pharmaceutical sciences

A simple and convenient method for the simultaneous in vitro study of metformin and glimepiride tablets.

Article

作者: Ahmed, Rehan

A simple and convenient method was developed for the simultaneous determination of metformin HCl and glimepiride in tablet dosage form of different pharmaceuticals companies. This method was validated and proved to be applicable for assay determination in intermediate and finished staged. More over a single medium dissolution of metformin HCl and glimepiride was established and the media was evaluated for comparative studies for different formulations. Reverse phase HPLC equipped with UV detector was used for the determination of metformin HCl and glimepiride. A mixture of acetonitrile and ammonium acetate buffer 0.05M pH 3.0 was used as mobile phase at flow rate of 1.0ml/min. Promocil C18 5µ 100Aº 4.6 x 100mm C18 silica column was used and detection was carried out at 270nm. Method was found to be linear over the range of 4ppm to 16ppm for glimepiride and 170ppm to 680ppm for metformin HCl. Regression co-efficient were found to be 0.9949 and 0.9864 for glimepiride and metformin HCl respectively. Dissolution was performed in 500ml 0.2% sodium lauryl sulfate at 37°C for 45min using paddle apparatus. Dissolution of glimepiride was found to be 98.60% and 101.08% in Orinase Met1 tablet and Amaryl M tablet respectively whereas metformin was found 99.41% and 98.59% in Orinase Met 1 tablet and Amaryl M tablet. RSD for all the dissolutions was less than 2.0% after completion.

100 项与格列美脲/盐酸二甲双胍相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
2型糖尿病	-	Sanofi	-

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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


NCT01561976 (CTgov)	N/A	2型糖尿病	30	METLEAD ForteSR (METLEAD ForteSR-Fasting)	(網鹽襯醖膚觸繭醖構構) = 窪範憲繭網獵構餘繭積壓構廠窪膚艱願艱鏇憲 (廠憲夢範淵鹽鏇淵鏇襯, 選齋鹹襯鹹網積繭膚顧 ~ 廠襯鹽廠製艱遞夢選艱) 更多	-	2017-10-16
				ForteSR (METLEAD ForteSR-Fed)	(網鹽襯醖膚觸繭醖構構) = 鏇繭願鹹鹽蓋蓋鏇憲遞壓構廠窪膚艱願艱鏇憲 (廠憲夢範淵鹽鏇淵鏇襯, 築願廠構遞憲艱蓋遞選 ~ 窪構獵鹽製顧顧獵鑰夢) 更多
NCT00612144 (Pubmed)	临床4期	2型糖尿病	209	Glimepiride/Metformin fixed-dose combination	(觸襯膚顧鑰構艱憲網獵) = 製壓鏇觸憲醖遞糧糧製艱鑰夢鏇窪齋觸顧簾餘 (襯範艱壓網構網製齋網 ) 更多	-	2014-11-01
				Metformin uptitration	(觸襯膚顧鑰構艱憲網獵) = 獵獵顧艱範醖鏇襯構衊艱鑰夢鏇窪齋觸顧簾餘 (襯範艱壓網構網製齋網 ) 更多