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)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin 100 mg/simvastatin 40 mg FDC; Metformin
Intervention description: Sitagliptin 100 mg/simvastatin 40 mg FDC tablet administered once daily in the evening for 6 weeks; Participants will continue pre-study dose of metformin tablet(s) >=1000 per day
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Simvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

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.
    

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