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

Use our guide to learn which trials are right for you!

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
We found this trial at
83
sites
1144
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
1333
mi
from 43215
Albuquerque, NM
Click here to add this to my saved trials
246
mi
from 43215
Altoona, PA
Click here to add this to my saved trials
434
mi
from 43215
Atlanta, GA
Click here to add this to my saved trials
495
mi
from 43215
Birmingham, AL
Click here to add this to my saved trials
1511
mi
from 43215
Bountiful, UT
Click here to add this to my saved trials
1967
mi
from 43215
Cerritos, CA
Click here to add this to my saved trials
362
mi
from 43215
Chattanooga, TN
Click here to add this to my saved trials
804
mi
from 43215
Cocoa, FL
Click here to add this to my saved trials
913
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
916
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
?
mi
from 43215
Decatur, GA
Click here to add this to my saved trials
1158
mi
from 43215
Denver, CO
Click here to add this to my saved trials
351
mi
from 43215
Durham, NC
Click here to add this to my saved trials
1723
mi
from 43215
Eagle, ID
Click here to add this to my saved trials
466
mi
from 43215
Elizabeth, NJ
Click here to add this to my saved trials
213
mi
from 43215
Flint, MI
Click here to add this to my saved trials
Fountain Valley, California 92708
1965
mi
from 43215
Fountain Valley, CA
Click here to add this to my saved trials
994
mi
from 43215
Galveston, TX
Click here to add this to my saved trials
989
mi
from 43215
Hialeah, FL
Click here to add this to my saved trials
670
mi
from 43215
Hot Springs, AR
Click here to add this to my saved trials
995
mi
from 43215
Houston, TX
Click here to add this to my saved trials
996
mi
from 43215
Houston, TX
Click here to add this to my saved trials
1001
mi
from 43215
Houston, TX
Click here to add this to my saved trials
996
mi
from 43215
Houston, TX
Click here to add this to my saved trials
410
mi
from 43215
Huntsville, AL
Click here to add this to my saved trials
1506
mi
from 43215
Idaho Falls, ID
Click here to add this to my saved trials
1980
mi
from 43215
Inglewood, CA
Click here to add this to my saved trials
660
mi
from 43215
Jackson, MS
Click here to add this to my saved trials
Jacksonville, North Carolina 28546
473
mi
from 43215
Jacksonville, NC
Click here to add this to my saved trials
451
mi
from 43215
Jonesboro, GA
Click here to add this to my saved trials
1926
mi
from 43215
La Jolla, CA
Click here to add this to my saved trials
626
mi
from 43215
Little Rock, AR
Click here to add this to my saved trials
1982
mi
from 43215
Lomita, CA
Click here to add this to my saved trials
308
mi
from 43215
Manassas, VA
Click here to add this to my saved trials
961
mi
from 43215
Margate, FL
Click here to add this to my saved trials
885
mi
from 43215
McKinney, TX
Click here to add this to my saved trials
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
995
mi
from 43215
Miami, FL
Click here to add this to my saved trials
994
mi
from 43215
Miami, FL
Click here to add this to my saved trials
982
mi
from 43215
Miami, FL
Click here to add this to my saved trials
996
mi
from 43215
Miami, FL
Click here to add this to my saved trials
996
mi
from 43215
Miami, FL
Click here to add this to my saved trials
996
mi
from 43215
Miami, FL
Click here to add this to my saved trials
986
mi
from 43215
Miami, FL
Click here to add this to my saved trials
989
mi
from 43215
Miami, FL
Click here to add this to my saved trials
992
mi
from 43215
Miami, FL
Click here to add this to my saved trials
?
mi
from 43215
Mobile, AL
Click here to add this to my saved trials
1109
mi
from 43215
New Braunfels, TX
Click here to add this to my saved trials
482
mi
from 43215
New Windsor, NY
Click here to add this to my saved trials
?
mi
from 43215
O'Fallon, IL
Click here to add this to my saved trials
849
mi
from 43215
Oklahoma City, OK
Click here to add this to my saved trials
683
mi
from 43215
Omaha, NE
Click here to add this to my saved trials
688
mi
from 43215
Omaha, NE
Click here to add this to my saved trials
?
mi
from 43215
Orlando, FL
Click here to add this to my saved trials
745
mi
from 43215
Ormond Beach, FL
Click here to add this to my saved trials
519
mi
from 43215
Perry, GA
Click here to add this to my saved trials
1654
mi
from 43215
Phoenix, AZ
Click here to add this to my saved trials
162
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
896
mi
from 43215
Plano, TX
Click here to add this to my saved trials
827
mi
from 43215
Plant City, FL
Click here to add this to my saved trials
900
mi
from 43215
Richardson, TX
Click here to add this to my saved trials
342
mi
from 43215
Richmond, VA
Click here to add this to my saved trials
2039
mi
from 43215
Sacramento, CA
Click here to add this to my saved trials
246
mi
from 43215
Saginaw, MI
Click here to add this to my saved trials
1138
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
1960
mi
from 43215
Santa Ana, CA
Click here to add this to my saved trials
874
mi
from 43215
Sarasota, FL
Click here to add this to my saved trials
577
mi
from 43215
Searcy, AR
Click here to add this to my saved trials
428
mi
from 43215
Smyrna, GA
Click here to add this to my saved trials
585
mi
from 43215
Springfield, MO
Click here to add this to my saved trials
406
mi
from 43215
St. Louis, MI
Click here to add this to my saved trials
1008
mi
from 43215
Sugar Land, TX
Click here to add this to my saved trials
965
mi
from 43215
Tamarac, FL
Click here to add this to my saved trials
826
mi
from 43215
Tampa, FL
Click here to add this to my saved trials
1985
mi
from 43215
Tarzana, CA
Click here to add this to my saved trials
252
mi
from 43215
Tipton, PA
Click here to add this to my saved trials
1636
mi
from 43215
Tucson, AZ
Click here to add this to my saved trials
1958
mi
from 43215
Tustin, CA
Click here to add this to my saved trials
301
mi
from 43215
Vernon Hills, IL
Click here to add this to my saved trials
99
mi
from 43215
Wadsworth, OH
Click here to add this to my saved trials
473
mi
from 43215
Wall, NJ
Click here to add this to my saved trials
West Reading, Pennsylvania 19611
374
mi
from 43215
West Reading, PA
Click here to add this to my saved trials