格列美脲/盐酸吡格列酮(Glimepiride/Pioglitazone Hydrochloride) - 药物靶点：KATP channels x PPARγ 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

Duetact、Pioglitazone/Glimepiride、Tandemact

+ [3]

靶点

KATP channels x PPARγ x SUR

作用机制

KATP通道阻滞剂、PPARγ激动剂(过氧化物酶体增长因子活化受体γ激动剂)、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

Takeda Pharmaceutical Co., Ltd.

在研机构

CHEPLAPHARM Arzneimittel GmbH

Takeda Pharmaceutical Co., Ltd.Takeda Pharmaceuticals U.S.A., Inc.

非在研机构-

最高研发阶段批准上市

首次获批日期

美国 (2006-07-28),

2型糖尿病

最高研发阶段(中国)-

特殊审评-

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结构

分子式C43H55ClN6O8S2

InChIKeyRWJPQBWTYNIUEF-NURFIRCWSA-N

CAS号2509313-62-4

关联

13

项与格列美脲/盐酸吡格列酮相关的临床试验

CTR20140390 / Recruiting临床3期

评价盐酸吡格列酮格列美脲片治疗2型糖尿病的有效性和安全性的多中心、随机、双盲双模拟、阳性对照临床研究

评价盐酸吡格列酮格列美脲片治疗2型糖尿病的有效性和安全性

开始日期2015-02-28

申办/合作机构

江苏德源药业股份有限公司

CTR20140389 / Completed临床1期

盐酸吡格列酮格列美脲片的生物等效性研究

选择男性健康志愿者为受试者，观察单剂量口服江苏德源药业有限公司研制的盐酸吡格列酮格列美脲片（15mg/1mg）后吡格列酮和格列美脲的血药浓度经时过程，估算相应的药代动力学参数，并以格列美脲片（商品名：亚莫利）和盐酸吡格列酮片（商品名：艾可拓）为标准参比制剂，进行生物利用度和生物等效性评价，为新药临床研究提供依据。

开始日期2014-09-17

申办/合作机构

江苏德源药业股份有限公司

CTR20150219 / Completed临床1期

吡格列酮格列美脲片人体生物利用度试验

健康受试者进行吡格列酮格列美脲片的人体生物利用度试验，考察吡格列酮格列美脲片与日本武田药品工业株式会社的盐酸吡格列酮片（艾可拓）和赛诺菲安万特（北京）制药有限公司生产的格列美脲片（亚莫利）的相对生物利用度，为制定吡格列酮格列美脲片II期临床试验方案提供试验依据，为临床用药的给药剂量提供依据。

开始日期2013-08-12

申办/合作机构

天津药物研究院有限公司

[+1]

100 项与格列美脲/盐酸吡格列酮相关的临床结果

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100 项与格列美脲/盐酸吡格列酮相关的转化医学

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100 项与格列美脲/盐酸吡格列酮相关的专利（医药）

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3

项与格列美脲/盐酸吡格列酮相关的文献（医药）

2017-01-01·Journal of Clinical Medicine Research

Effect of Switching From an Anti-Diabetic Loose Dose Combination to a Fixed Dose Combination Regimen at Equivalent Dosage for 6 Months on Glycemic Control in Japanese Patients With Type 2 Diabetes: A Pilot Study

Article

作者: Taguri, Masataka ; Kamiyama, Hiroshi ; Kamiko, Kazunari ; Terauchi, Yasuo ; Furuie, Tadashi ; Aoki, Kazutaka ; Nakajima, Shigeru ; Masumura, Makoto ; Nagakura, Mieko ; Oka, Masanao ; Akema, Noriko

BACKGROUNDPatients with type 2 diabetes mellitus often take multiple anti-diabetic drugs for a long period. Fixed dose combination (FDC) therapy is expected to improve drug adherence for patients with diabetes. The effect of switching from a loose dose combination (LDC) regimen to an FDC regimen at equivalent dosage on glycemic control has not been evaluated fully. Therefore, we investigated the effect of switching from LDC to FDC at equivalent dosage for 6 months on glycemic control in Japanese patients with type 2 diabetes.METHODSThirty-eight Japanese patients with type 2 diabetes who were taking anti-diabetic drugs including pioglitazone + metformin, pioglitazone + alogliptin, or pioglitazone + glimepiride were enrolled. These drugs were switched to an FDC of Metact^®, Liobel^® or Sonias^®, respectively, at equivalent dosage. Other anti-diabetic drugs and units of insulin were not changed during the study if possible. HbA1c and body weight were measured 0, 2, 4 and 6 months after switching from an LDC to FDC. We also conducted a questionnaire survey 2 months after the start of the FDC regimen.RESULTSHbA1c levels at 2, 4, and 6 months were not significantly changed compared with prior to switching from an LDC to FDC regimen. Moreover, 74.2% of patients considered decreasing the number of drugs to be "very good" or "good".CONCLUSIONHbA1c levels did not differ between patients receiving LDC and FDC therapy at equivalent dosage in this study.

2011-06-29·BMJ

European drug agency extends review of safety of pioglitazone

作者: Moynihan, R.

The European Medicines Agency will decide the fate of the type 2 diabetes treatment pioglitazone later in July, after the release of new data indicating that long term use is associated with a slightly raised risk of bladder cancer. New warnings have been issued in the United States, while French authorities have suspended use of drugs containing pioglitazone, which is sold under brand names including Actos, Glustin, Competact, Glubrava, and Tandemact. Marketed for more than a decade, pioglitazone had total sales last year of almost £3bn (€3.4bn; $4.8bn) and is an important earner for the Japanese company Takeda. A competitor drug, rosiglitazone (sold as Avandia), was withdrawn from the European market last year after evidence …

2007-03-17·BMJ

Fracture risk a class effect of thiazolidinediones in women

作者: Short, Robert

Treatment with thiazolidinediones (glitazones) for type 2 diabetes has been found to increase the risk of fractures in women. Pioglitazone has now joined rosiglitazone, as the subject of a US Food and Drug Administration alert for fracture risk. Takeda, the makers of pioglitazone (contained in Actos, Actosplusmet, and Duetact), and GlaxoSmithKline, the makers of rosiglitazone (contained in Avandia and Avandamet), have contacted US healthcare professionals setting out the evidence on fracture risk and recommending that they consider this risk when starting or treating women with type 2 diabetes with these agents. The statement on pioglitazone …

100 项与格列美脲/盐酸吡格列酮相关的药物交易

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