Delving into the Latest Updates on Simvastatin/Sitagliptin Phosphate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Januvia/Zocor, Juvicor, Juvisync

+ [6]

Target

DPP-4 x HMGCR

Action

inhibitors

Mechanism

DPP-4 inhibitors(Dipeptidyl peptidase IV inhibitors), HMG-CoA reductase inhibitors(HMG-CoA reductase inhibitors)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

DyslipidemiasDiabetes Mellitus, Type 2

Inactive Indication

Coronary Artery DiseaseCoronary DiseaseHomozygous familial hypercholesterolemia+ [5]

Originator Organization

Merck Sharp & Dohme Corp.

Active Organization

Merck GmbH

Inactive Organization

Merck Sharp & Dohme Corp.

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (07 Oct 2011),

Coronary Artery DiseaseCoronary DiseaseDiabetes Mellitus, Type 2+ [7]

Regulation-

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Structure/Sequence

Molecular FormulaC25H38O5

InChIKeyRYMZZMVNJRMUDD-HGQWONQESA-N

CAS Registry79902-63-9

View All Structures (2)

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.

Start Date10 Oct 2012

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

100 Clinical Results associated with Simvastatin/Sitagliptin Phosphate

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100 Translational Medicine associated with Simvastatin/Sitagliptin Phosphate

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100 Patents (Medical) associated with Simvastatin/Sitagliptin Phosphate

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1

Literatures (Medical) associated with Simvastatin/Sitagliptin Phosphate

Vascular Health and Risk Management

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

Review

Author: 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 Deals associated with Simvastatin/Sitagliptin Phosphate

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A10BH51	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dyslipidemias	Australia	Merck GmbH	22 Apr 2015
Diabetes Mellitus, Type 2	Australia	Merck GmbH	15 Apr 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 1	United States	Merck Sharp & Dohme Corp.	07 Oct 2011

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01678820 (0431D-266, CTgov)	Phase 3	Diabetes Mellitus, Type 2	299	Placebo to sitagliptin+metformin+Glimepiride+Sitagliptin/Simvastatin FDC (Sitagliptin/Simvastatin FDC)	rsculiggyj(tzquoesanu) = aynkhpbuih whbayvujcp (jlbxelmkrm, wettuouffu - sllfqjhkfa) View more	-	22 Oct 2014
NCT01678820 (0431D-266, CTgov)	Phase 3	Diabetes Mellitus, Type 2	299	Placebo to Sitagliptin/Simvastatin FDC+sitagliptin+metformin+Glimepiride (Sitagliptin)	rsculiggyj(tzquoesanu) = nxnhbtbiae whbayvujcp (jlbxelmkrm, rbsahvljss - paneqibhoj) View more	-	22 Oct 2014
NCT01702298 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	42	Metformin+Sitagliptin 100 mg/simvastatin 40 mg FDC	xdpjquhnug(bedrefsaqm) = alioacyhax bejbaplayj (vobcxqqmtz, edrxqjcbls - ftivjdqeay) View more	-	30 May 2014