A Study to Assess the Safety and Tolerability of Sitagliptin/Simvastatin Fixed-dose Combination (FDC) in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-312) | RxWiki

A Study to Assess the Safety and Tolerability of Sitagliptin/Simvastatin Fixed-dose Combination (FDC) in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-312)

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: Sitagliptin 100/simvastatin 40 FDC Drug: Metformin
Phase	Phase 3
Sponsor	Merck Sharp & Dohme Corp.
Responsible Party	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier	NCT01702298
First Received	October 4, 2012
Last Updated	July 10, 2013
Last verified	July 2013

Tracking Information[ + expand ][ + ]

First Received Date	October 4, 2012
Last Updated Date	July 10, 2013
Start Date	December 2012
Estimated Primary Completion Date	May 2013
Current Primary Outcome Measures	Change from baseline in fasting plasma glucose (FPG) [Time Frame: Baseline and Week 6] [Designated as safety issue: No] Number of participants who experienced at least one adverse event [Time Frame: Up to 8 weeks (including 14 days after final dose of study drug)] [Designated as safety issue: Yes] Number of participants who discontinued study drug due to an adverse event [Time Frame: Up to 6 weeks] [Designated as safety issue: Yes]
Current Secondary Outcome Measures	Change from baseline in low-density lipoprotein cholesterol (LDL-C) [Time Frame: Baseline and Week 6] [Designated as safety issue: No] Change from baseline in total cholesterol (TC) [Time Frame: Baseline and Week 6] [Designated as safety issue: No] Change from baseline in non-high density lipoprotein cholesterol (non-HDL-C) [Time Frame: Baseline and Week 6] [Designated as safety issue: No] Change from baseline in triglycerides (TG) [Time Frame: Baseline and Week 6] [Designated as safety issue: No] Change from baseline in high-density lipoprotein cholesterol (HDL-C) [Time Frame: Baseline and Week 6] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	A Study to Assess the Safety and Tolerability of Sitagliptin/Simvastatin Fixed-dose Combination (FDC) in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-312)
Official Title	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: Sitagliptin 100/simvastatin 40 FDC Sitagliptin 100 mg/simvastatin 40 mg FDC tablet administered once daily in the evening for 6 weeks Other Names: MK-0431DDrug: Metformin Participants will continue pre-study dose of metformin tablet(s) >=1000 per day Other Names: Fortamet® Glucophage® Glucophage® XR Glumetza® Riomet® Metgluco® Glycoran®
Study Arm (s)	Experimental: Sitagliptin 100/simvastatin 40 FDC Simvastatin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants will continue pre-study dose of metformin >=1000 mg per day.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	42
Estimated Completion Date	May 2013
Estimated Primary Completion Date	May 2013
Eligibility Criteria	Inclusion Criteria: - Has type 2 diabetes mellitus - Male, or female who is not of reproductive potential or if of reproductive potential agrees to abstain or use (or have their partner use) two acceptable methods of birth control during the study and for 14 days after the last dose of study drug - Currently on metformin monotherapy (>=1000 mg per day) for at least 4 weeks prior to study participation - Not on statin therapy or other lipid-lowering agent for at least 6 weeks prior to study participation Exclusion Criteria: - History of type 1 diabetes mellitus or a history of ketoacidosis - History of 2 or more episodes of hypoglycemia resulting in seizure, coma or loss of consciousness over the past 3 months - On a thiazolidinedione (TZD) within the past 12 weeks - Has been treated with a statin or other lipid-lowering agent within 6 weeks prior to study participation - Is on or likely to require treatment with a prohibited medication (itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, gemfibrozil, cyclosporine, danazol, amiodarone, verapamil, diltiazem, amlodipine, ranolazine, niacin) - Intends to consume >1.2 liters of grapefruit juice per day during the study - Is on or likely to require treatment for >=2 consecutive weeks or repeated courses of corticosteroids (inhaled, nasal and topical corticosteroids are permitted) - Is on a weight loss program and not in the maintenance phase or has started a weight loss medication or has undergone bariatric surgery within 12 months prior to study participation - Has undergone a surgical procedure within 4 weeks of study participation or has planned major surgery during the study - History of myopathy or rhabdomyolysis with any statin - History of myocardial infarction, unstable or stable angina, angioplasty, bypass surgery, myocardial ischemia, peripheral artery disease, abdominal aortic aneurysm, transient ischemic attacks, stroke of carotid origin or >50% obstruction of a carotid artery - Diagnosis of congestive heart failure with New York Heart Association (NYHA) Class III or IV cardiac status - History of active liver disease (other than non-alcoholic steatosis) including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease - Chronic progressive neuromuscular disorder - Human immunodeficiency virus (HIV) - Hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) - Currently being treated for hyperthyroidism or is on thyroid hormone replacement therapy and has not been on a stable dose for at least 6 weeks - History of malignancy <=5 years prior to study participation, except for basal cell or squamous cell skin cancer or in situ cervical cancer - Positive urine pregnancy test - Pregnant or breastfeeding, or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study drug - User of recreational or illicit drugs or has had a recent history of drug abuse - Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT01702298
Other Study ID Numbers	0431D-312
Has Data Monitoring Committee	Yes
Information Provided By	Merck Sharp & Dohme Corp.
Study Sponsor	Merck Sharp & Dohme Corp.
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	July 2013