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.

Start Date07 Dec 2012

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

NCT01678820 / TerminatedPhase 3

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.

Start Date10 Oct 2012

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

100 Clinical Results associated with Simvastatin/Sitagliptin Phosphate

100 Translational Medicine associated with Simvastatin/Sitagliptin Phosphate

100 Patents (Medical) associated with Simvastatin/Sitagliptin Phosphate

Literatures (Medical) associated with Simvastatin/Sitagliptin Phosphate

14 Nov 2011·The Medical letter on drugs and therapeuticsQ4 · MEDICINE

Sitagliptin and simvastatin (juvisync).

Q4 · MEDICINE

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

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

External Link

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R&D Status

Approved

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

Developing

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

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)	qxiprhkaph(xbrxqcupws) = hgcqglzlwz yryvppyvfl (gckwsiczkw, tqnxozihqh - zfmnxljgji) 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)	qxiprhkaph(xbrxqcupws) = xacqdwmgqr yryvppyvfl (gckwsiczkw, ucsrarnoku - oudwervnyq) View more	-	22 Oct 2014
NCT01702298 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	42	Metformin+Sitagliptin 100 mg/simvastatin 40 mg FDC	rmfqjfswuh(ubotmbdvgk) = unmmfcgmpk fzuuayjnbb (flyvsuxqha, ywnskgkqbm - miyyybdjvm) View more	-	30 May 2014

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