辛伐他汀/磷酸西格列汀一水合物(Simvastatin/Sitagliptin Phosphate) - 药物靶点：DPP-4 x HMGCR_在研适应症：血脂障碍，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

Januvia/Zocor、Juvicor、Juvisync

+ [6]

靶点

DPP-4 x HMGCR

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)、HMG-CoA reductase抑制剂(羟甲基戊二酰辅酶A合酶抑制剂)

治疗领域

内分泌与代谢疾病

在研适应症

血脂障碍2型糖尿病

非在研适应症

冠心病冠状动脉疾病纯合子家族性高胆固醇血症+ [5]

原研机构

Merck Sharp & Dohme Corp.

在研机构

Merck GmbH

非在研机构

Merck Sharp & Dohme Corp.

最高研发阶段批准上市

首次获批日期

美国 (2011-10-07),

冠心病冠状动脉疾病2型糖尿病+ [7]

最高研发阶段(中国)-

特殊审评-

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结构/序列

分子式C25H38O5

InChIKeyRYMZZMVNJRMUDD-HGQWONQESA-N

CAS号79902-63-9

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关联

3

项与辛伐他汀/磷酸西格列汀一水合物相关的临床试验

EUCTR2012-001868-29-CZ

/ Not yet recruiting临床3期

A Phase III, Randomized, Double-Blind, Clinical Trial to Studythe Efficacy and Safety of MK-0431D (a fixed-dose combination[FDC] of sitagliptin and simvastatin) for the Treatment of PatientsWith Type 2 Diabetes Mellitus (T2DM) with Inadequate GlycemicControl on Metformin Monotherapy

开始日期2013-03-18

申办/合作机构-

NCT01702298

/ Completed临床3期

An Open-label Study to Assess the Safety and Tolerability of MK-0431D for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy

The purpose of this study is to examine the safety and tolerability of sitagliptin 100 mg/simvastatin 40 mg FDC (MK-0431D) in Vietnamese participants with type 2 diabetes mellitus with inadequate glycemic control on metformin.

开始日期2012-12-07

申办/合作机构

Merck Sharp & Dohme Corp.

NCT01678820

/ Terminated临床3期

A Phase III, Randomized, Double-blind, Clinical Trial to Study the Efficacy and Safety of MK-0431D (a Fixed-dose Combination [FDC] of Sitagliptin and Simvastatin) for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy

The purpose of this study is to assess the efficacy and safety of sitagliptin/simvastatin fixed-dose combination (FDC) in participants with T2DM who have inadequate glycemic control while on metformin monotherapy. The primary hypothesis of this study is that after 16 weeks of therapy, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with sitagliptin/simvastatin FDC is non-inferior compared to sitagliptin alone.

开始日期2012-10-10

申办/合作机构

Merck Sharp & Dohme Corp.

100 项与辛伐他汀/磷酸西格列汀一水合物相关的临床结果

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100 项与辛伐他汀/磷酸西格列汀一水合物相关的转化医学

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100 项与辛伐他汀/磷酸西格列汀一水合物相关的专利（医药）

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1

项与辛伐他汀/磷酸西格列汀一水合物相关的文献（医药）

Vascular Health and Risk Management

Sitagliptin/Simvastatin: a first combination tablet to treat type 2 diabetes and hypercholesterolemia – a review of its characteristics

Review

作者: Ramadan, Wijdan H ; Kabbara, Wissam K

BACKGROUNDThe purpose of this study was to review the current literature and information on the combination product Juvisync™ (sitagliptin + simvastatin), which was approved by the US Food and Drug Administration in October 2011.METHODSPubMed (2001-2014) was searched for primary and review articles on sitagliptin, simvastatin, or the combination product. Drug manufacturing data and product labeling were also used. Studies of simvastatin, sitagliptin, or the combination were screened and analyzed to include relevant and recent papers. Selected English language trials were limited to those with human subjects and included both safety and efficacy outcomes.RESULTSWhen compared with glipizide as add-on therapy to metformin, sitagliptin was noninferior but had lower rates of hypoglycemia and weight gain. In addition, when compared with insulin glargine, sitagliptin was less effective in decreasing glycosylated hemoglobin, but was associated with significantly lower rates of hypoglycemia. Further, trials have shown a beneficial effect of using statins in patients with diabetes mellitus with regard to decreasing cardiovascular risk, regardless of baseline lipid levels or the presence of a cardiac disease. Both medications have also demonstrated an acceptable side effect profile. However, caution is needed when coadministering with any drug that may increase simvastatin levels to reduce the risk of myopathy and rhabdomyolysis.CONCLUSIONJuvisync should be used in patients requiring both sitagliptin and simvastatin. Both agents have shown good efficacy and acceptable safety profiles. Sitagliptin is a good option for diabetic patients to improve glycemic control with a lower risk of hypoglycemia and weight gain.

100 项与辛伐他汀/磷酸西格列汀一水合物相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	A10BH51	-

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
血脂障碍	澳大利亚	Merck GmbH	2015-04-22
2型糖尿病	澳大利亚	Merck GmbH	2015-04-15

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
2型糖尿病	临床1期	美国	Merck Sharp & Dohme Corp.	2011-10-07

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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


NCT01678820 (0431D-266, CTgov)	临床3期	2型糖尿病	299	Placebo to sitagliptin+metformin+Glimepiride+Sitagliptin/Simvastatin FDC (Sitagliptin/Simvastatin FDC)	觸範繭遞蓋齋鏇齋鬱獵(製顧鹽網製淵範選壓遞) = 範繭艱網鹹鹹鹽艱餘獵築選艱選簾獵醖觸膚淵 (憲夢廠淵窪遞廠製獵選, 願齋鏇廠築齋齋衊艱構 ~ 窪願壓艱鹽窪鹹製膚襯) 更多	-	2014-10-22
NCT01678820 (0431D-266, CTgov)	临床3期	2型糖尿病	299	Placebo to Sitagliptin/Simvastatin FDC+sitagliptin+metformin+Glimepiride (Sitagliptin)	觸範繭遞蓋齋鏇齋鬱獵(製顧鹽網製淵範選壓遞) = 獵繭願壓鹹願鑰憲製積築選艱選簾獵醖觸膚淵 (憲夢廠淵窪遞廠製獵選, 簾餘襯廠蓋鏇鑰製襯憲 ~ 繭鏇顧網選遞齋壓醖願) 更多	-	2014-10-22
NCT01702298 (CTgov)	临床3期	2型糖尿病	42	Metformin+Sitagliptin 100 mg/simvastatin 40 mg FDC	鬱襯襯願簾構襯觸壓廠(窪積壓憲廠製餘廠糧鏇) = 顧壓艱糧窪構獵簾齋鏇構遞窪餘願餘餘淵築蓋 (遞選觸鹽選範襯齋鹽鹹, 網鹹願憲廠衊鹽糧簾夢 ~ 顧窪選網範製繭淵遞廠) 更多	-	2014-05-30