Phase
Condition
Diabetes Prevention
Diabetes Mellitus, Type 2
Diabetes And Hypertension
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Type 2 diabetes mellitus as per American Diabetes Association guidelines
On metformin monotherapy (>=1500 mg/day) for >=8 weeks with a Visit 1/Screening A1C >=7.5% and <=11.0% (>=58 mmol/mol and <=97 mmol/mol) OR On metformin monotherapy (>=1500 mg/day) for <8 weeks with a Visit 1/Screening A1C >=7.5% and <=11.0% (>=58mmol/mol and <=97 mmol/mol) OR On metformin monotherapy <1500 mg/day with a Visit 1/Screening A1C >=8.0% and <=11.5% (>=64 mmol/mol and <=102 mmol/mol)
Body mass index (BMI) >=18.0 kg/m^2
Male or female not of reproductive potential
Female of reproductive potential who agrees to remain abstinent from heterosexualactivity or to use 2 acceptable combinations of contraception
Exclusion
Exclusion Criteria:
History of type 1 diabetes mellitus or ketoacidosis
History of other specific types of diabetes (e.g., genetic syndromes, secondarypancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, andpost-organ transplant
A known hypersensitivity or intolerance to any sodium glucose co-transporter 2 (SGLT2)inhibitor or sitagliptin
Has been treated with any of the following agents within 12 weeks of study start orduring the pre-randomization period: Insulin of any type (except for short-term use [i.e., <=7 days] during concomitant illness or other stress), other injectableanti-hyperglycemic agents (e.g., pramlintide, exenatide, liraglutide), pioglitazone orrosiglitazone, other SGLT2 inhibitors, alpha glucosidase inhibitors or meglitinides,dipeptidyl-peptidase 4 inhibitor (DPP-4 inhibitor), sulfonylureas (SUs), bromocriptine (Cycloset™), colesevelam (Welchol™), any other antihyperglycemic agents (AHA) with theexception of the protocol-approved agents
Is on a weight-loss program or weight-loss medication or other medication associatedwith weight changes and is not weight stable prior to study start
Has undergone bariatric surgery within the past 12 months or >12 months and is notweight stable prior to study start
A history of myocardial infarction, unstable angina, arterial revascularization,stroke, transient ischemic attack, or New York Heart Association (NYHA) functionalclass III-IV heart failure within 3 months of study start
Active, obstructive uropathy or indwelling urinary catheter
History of malignancy <=5 years prior to study start, except for adequately treatedbasal cell or squamous cell skin cancer or in situ cervical cancer
A known history of human immunodeficiency virus (HIV)
A blood dyscrasia or any disorder causing hemolysis or unstable red blood cells, or aclinically important hematological disorder (e.g. aplastic anemia, myeloproliferativeor myelodysplastic syndromes, thrombocytopenia)
A medical history of active liver disease (other than non-alcoholic hepaticsteatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, orsymptomatic gallbladder disease
Any clinically significant malabsorption condition
Current treatment for hyperthyroidism
On thyroid replacement therapy and not on a stable dose for at least 6 weeks priorstudy start
On a previous clinical study with ertugliflozin
Estimated glomerular filtration rate (eGFR) (using the 4-variable Modification of Dietin Renal Disease Study Equation (MDRD) equation) <60 mL/min/1.73 m^2
Serum creatinine >= 1.3 mg/dL (115 µmol/L) for males and >= 1.2 mg/dL (106 µmol/L) forfemales
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times upperlimit of normal
Hemoglobin <12 g/dL (120 g/L) for males and <11 g/dL (110 g/L) for females.
Participated in other studies involving investigational drug(s) 30 days prior to studystart
Surgical procedure within 6 weeks prior to study start or major surgery planned duringthe trial
Positive urine pregnancy test
Pregnant or breast-feeding, or planning to conceive during the trial, including 14days following the last dose of study medication
Planning to undergo hormonal therapy in preparation for egg donation during the trial,including 14 days following the last dose of study medication
Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week orengages in binge drinking
Donated blood or blood products within 6 weeks of study start
Study Design
Study Description
Connect with a study center
Merck Sharp & Dohme (Argentina) Inc.
Buenos Aires,
ArgentinaSite Not Available
Merck Sharp & Dohme Bulgaria EOOD
Sofia,
BulgariaSite Not Available
Merck Canada
Kirkland, Quebec H9H 3L1
CanadaSite Not Available
MDS Colombia SAS
Bogota,
ColombiaSite Not Available
Merck Sharp and Dohme s.r.o.
Praha,
Czech RepublicSite Not Available
MSD Finland Oy
Espoo,
FinlandSite Not Available
MSD Pharma Hungary Kft.
Budapest,
HungarySite Not Available
Merck Sharp & Dohme Co. Ltd.
Hod Hasharon,
IsraelSite Not Available
MSD
Petaling Jaya,
MalaysiaSite Not Available
MSD
Mexico City,
MexicoSite Not Available
Merck Sharp & Dohme (New Zealand) Ltd.,
Wellington,
New ZealandSite Not Available
Merck Sharp & Dohme (I.A.) Corporation
Makati,
PhilippinesSite Not Available
MSD Polska Sp. Z o.o.
Warsaw,
PolandSite Not Available
Merck Sharp & Dohme Romania SRL
Bucharest,
RomaniaSite Not Available
Merck Sharp & Dohme IDEA, Inc.
Moscow,
Russian FederationSite Not Available
Merck Sharp Dohme S.R.O.
Bratislava,
SlovakiaSite Not Available
MSD (Thailand) Ltd.
Bangkok,
ThailandSite Not Available
MSD Ukraine LLC
Kiev,
UkraineSite Not Available
Call for Information (Investigational Site 0083)
Tucson, Arizona 85704
United StatesSite Not Available
Call for Information (Investigational Site 0051)
Chino, California 91710
United StatesSite Not Available
Call for Information (Investigational Site 0040)
Hawaiian Gardens, California 90716
United StatesSite Not Available
Call for Information (Investigational Site 0030)
Lincoln, California 95648
United StatesSite Not Available
Call for Information (Investigational Site 0039)
Los Angeles, California 90057
United StatesSite Not Available
Call for Information (Investigational Site 0093)
Rancho Cucamonga, California 91730
United StatesSite Not Available
Call for Information (Investigational Site 0019)
Spring Valley, California 91978
United StatesSite Not Available
Call for Information (Investigational Site 0090)
Upland, California 91786
United StatesSite Not Available
Call for Information (Investigational Site 0104)
West Hills, California 91307
United StatesSite Not Available
Call for Information (Investigational Site 0068)
Colorado Springs, Colorado 80909
United StatesSite Not Available
Call for Information (Investigational Site 0105)
Denver, Colorado 80220
United StatesSite Not Available
Call for Information (Investigational Site 0011)
Hialeah, Florida 33012
United StatesSite Not Available
Call for Information (Investigational Site 0099)
Homestead, Florida 33030
United StatesSite Not Available
Call for Information (Investigational Site 0100)
Miami, Florida 33185
United StatesSite Not Available
Call for Information (Investigational Site 0024)
Opa Locka, Florida 33054
United StatesSite Not Available
Call for Information (Investigational Site 0107)
Pembroke Pines, Florida 33028
United StatesSite Not Available
Call for Information (Investigational Site 0145)
Atlanta, Georgia 30342
United StatesSite Not Available
Call for Information (Investigational Site 0103)
Roswell, Georgia 30076
United StatesSite Not Available
Call for Information (Investigational Site 0146)
Chicago, Illinois 60607
United StatesSite Not Available
Call for Information (Investigational Site 0098)
Greenfield, Indiana 46140
United StatesSite Not Available
Call for Information (Investigational Site 0059)
Bangor, Maine 04401
United StatesSite Not Available
Call for Information (Investigational Site 0057)
Oxon Hill, Maryland 20745
United StatesSite Not Available
Call for Information (Investigational Site 0048)
New York, New York 10016
United StatesSite Not Available
Call for Information (Investigational Site 0003)
Morehead City, North Carolina 28557
United StatesSite Not Available
Call for Information (Investigational Site 0017)
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Call for Information (Investigational Site 0078)
Fargo, North Dakota 58103
United StatesSite Not Available
Call for Information (Investigational Site 0015)
Perrysburg, Ohio 43551
United StatesSite Not Available
Call for Information (Investigational Site 0052)
Norman, Oklahoma 73069
United StatesSite Not Available
Call for Information (Investigational Site 0095)
Oklahoma City, Oklahoma 73103
United StatesSite Not Available
Call for Information (Investigational Site 0079)
Portland, Oregon 97220
United StatesSite Not Available
Call for Information (Investigational Site 0080)
Altoona, Pennsylvania 16602
United StatesSite Not Available
Call for Information (Investigational Site 0102)
Levittown, Pennsylvania 19056-2404
United StatesSite Not Available
Call for Information (Investigational Site 0082)
Pittsburgh, Pennsylvania 15236
United StatesSite Not Available
Call for Information (Investigational Site 0074)
Austin, Texas 78745
United StatesSite Not Available
Call for Information (Investigational Site 0016)
El Paso, Texas 79925
United StatesSite Not Available
Call for Information (Investigational Site 0089)
Houston, Texas 77074
United StatesSite Not Available
Call for Information (Investigational Site 0109)
San Antonio, Texas 78205
United StatesSite Not Available
Call for Information (Investigational Site 0081)
Tomball, Texas 77375
United StatesSite Not Available
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