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 AM1)



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 79
Updated:10/3/2013
Start Date:October 2012
End Date:November 2014
Contact:Toll Free Number
Phone:1-888-577-8839

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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.


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 over 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
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