A Study of the Efficacy and Safety of MK-0431D (a Fixed-dose Combination of Sitagliptin and Simvastatin) for the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-266)
Type 2 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- has T2DM
- (1) Male; (2) female not of reproductive potential; or (3) female of reproductive potential who agrees to remain abstinent or use alone or in conjunction with their partner 2 methods of contraception to prevent pregnancy during the study and for 14 days after the last dose of study drug
- is currently on metformin monotherapy at a daily dose of at least 1500 mg for at least 10 weeks
- is not on a lipid-lowering agent for at least 6 weeks prior to entering the study
Exclusion Criteria:
- has history of type 1 diabetes mellitus (T1DM), or a history of ketoacidosis or possibly has T1DM
- has been on a thiazolidinedione (TZD) within the previous 16 weeks
- has been treated with a statin or other lipid-lowering agent (including over-the-counter [OTC] supplements) within the previous 6 weeks
- currently participating in or has participated in another clinical study within the past 12 weeks
- intends to consume >1.2 liters of grapefruit juice daily during the study
- is on or likely to require treatment for at least 2 consecutive weeks or repeated courses of corticosteroids (inhaled, nasal and topical corticosteroids are permitted)
- intolerance or hypersensitivity to sitagliptin, simvastatin, metformin or glimepiride
- is on a weight loss program and not in the maintenance phase or has started a weight loss medication or has undergone bariatric surgery in the previous 12 months
- has undergone a surgical procedure in the past 4 weeks or planned major surgery during the study
- has symptomatic hyperglycemia that requires immediate initiation, adjustment, or addition of antihyperglycemic therapy
- has a history of myopathy or rhabdomyolysis with any statin
- has cardiovascular disease, a diagnosis of congestive heart failure, or uncontrolled high blood pressure
- has a history of active liver disease
- has chronic progressive neuromuscular disorder, human immunodeficiency virus (HIV), hematological disorder, or uncontrolled endocrine or metabolic disease
- is currently being treated for hyperthyroidism or is on thyroid hormone therapy and has not been on a stable dose for at least 6 weeks
- has a history of malignancy in the previous 5 years (excluding adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer)
- is pregnant or breast feeding, or is expecting to conceive or donate eggs during the course of the study, including 14 days after the last dose of study drug
- is a user of recreational or illicit drugs or has had a recent history of drug abuse
- consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Sitagliptin/Simvastatin FDC
Sitagliptin
Simvastatin
Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening for 16 weeks. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.