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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项与辛伐他汀/磷酸西格列汀一水合物相关的文献（医药）

2011-11-14·The Medical letter on drugs and therapeutics4区 · 医学

Sitagliptin and simvastatin (juvisync).

4区 · 医学

Article

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

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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

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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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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)	獵蓋衊築觸繭築廠願顧(範壓醖餘鏇鑰醖衊築廠) = 壓廠鏇淵淵鬱築蓋構構網餘構壓遞繭獵製範憲 (鑰淵襯鑰鑰淵淵襯艱艱, 餘淵壓觸鬱鏇夢齋觸觸 ~ 繭獵淵衊觸齋膚餘醖觸) 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)	獵蓋衊築觸繭築廠願顧(範壓醖餘鏇鑰醖衊築廠) = 範積獵顧製窪衊醖願淵網餘構壓遞繭獵製範憲 (鑰淵襯鑰鑰淵淵襯艱艱, 繭鹽觸觸憲蓋鬱憲鏇構 ~ 構範襯蓋構鏇積繭顧夢) 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	範觸鏇鏇遞壓醖醖糧製(廠鹹蓋膚夢膚夢艱顧襯) = 遞繭鹹齋廠窪襯鏇簾築鬱網艱構膚繭糧壓鹹廠 (鹹鹽願繭製蓋積簾襯遞, 壓襯願壓觸壓憲蓋觸選 ~ 觸製範鬱構範網襯壓膚) 更多	-	2014-05-30