Phase
Condition
Diabetes Mellitus, Type 2
Diabetes And Hypertension
Nephropathy
Treatment
N/AClinical Study ID
Ages > 25 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
Have T2DM at Screening visit
Be on metformin monotherapy ≥1500 mg/day alone or in combination with an sulfonylureaagent (at a dose of ≥ 50% maximum labeled dose in the country of the investigationalsite) for ≥8 weeks
Is a male or a female not of reproductive potential (defined as one who ispostmenopausal or has had a hysterectomy and/or bilateral oophorectomy, or hadbilateral tubal ligation or occlusion at least 6 weeks prior to Screening visit). Ifparticipant is a female of reproductive potential, must agree to remain abstinent fromheterosexual activity or agrees to use (or have her partner use) acceptablecontraception to prevent pregnancy while receiving blinded study drug and for 14 daysafter the last dose of blinded study drug
Exclusion
Exclusion Criteria:
Has a history of type 1 diabetes mellitus or a history of ketoacidosis
Has a history of secondary causes of diabetes
Has a known hypersensitivity or intolerance to any dipeptidyl peptidase IV (DPP-4)inhibitor or sodium-glucose cotransporter 2 (SGLT2) inhibitor
Has been treated with any anti-hyperglycemic agents (AHA) other than metformin and forparticipants on dual combination therapy, a sulfonylurea within 12 weeks of screening
Intends to initiate weight loss medication during the study period
Has undergone bariatric surgery within 12 months of Screening visit
Has started a weight loss medication or a medication associated with weight changeswithin the prior 12 weeks.
Has a history of myocardial infarction, unstable angina, arterial revascularization,stroke, transient ischemic attack, heart failure within 3 months of Screening visit
Has a history of malignancy ≤5 years prior to study, except for adequately treatedbasal cell or squamous cell skin cancer or in situ cervical cancer
Has human immunodeficiency virus (HIV)
Has blood dyscrasias or any disorders causing hemolysis or unstable red blood cells,or clinically important hematological disorder (such as aplastic anemia,myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
Has a medical history of active liver disease (other than non-alcoholic hepaticsteatosis), including chronic hepatitis B or C, primary biliary cirrhosis, orsymptomatic gallbladder disease
Is currently being treated for hyperthyroidism or is on thyroid replacement therapyand has not been on a stable dose for at least 6 weeks prior to Screening visit
Is on or likely to require treatment for ≥14 consecutive days or repeated courses ofcorticosteroids
Is on or likely to require treatment for ≥7 consecutive days with non-steroidalanti-inflammatory drugs
Is pregnant or breast-feeding, or is planning to conceive during the study, including 14 days following the last dose of blinded study drug
Is planning to undergo hormonal therapy in preparation to donate eggs during thestudy, including 14 days following the last dose of blinded study drug
Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week orengages in binge drinking
Has donated blood or blood products within 6 weeks of Screening visit or who plans todonate blood or blood products at any time during the study
Study Design
Connect with a study center
Merck Sharp & Dohme (Argentina) Inc.
Buenos Aires,
ArgentinaSite Not Available
Merck Sharp & Dohme
North Ryde,
AustraliaSite Not Available
MSD Brasil
Sao Paulo,
BrazilSite Not Available
Merck Canada
Kirkland, Quebec H9H 3L1
CanadaSite Not Available
MDS Colombia SAS
Bogota,
ColombiaSite Not Available
Merck Sharp & Dohme OU
Tallinn,
EstoniaSite Not Available
MSD Finland Oy
Espoo,
FinlandSite Not Available
MSD Sharp & Dohme GmbH
Haar,
GermanySite Not Available
MSD Pharma Hungary Kft.
Budapest,
HungarySite Not Available
MSD Ireland (Human Health) Ltd.
Dublin,
IrelandSite Not Available
MSD Korea LTD
Seoul,
Korea, Republic ofSite Not Available
Merck Sharp & Dohme Latvija SIA
Riga,
LatviaSite Not Available
UAB "Merck Sharp & Dohme"
Vilnius,
LithuaniaSite Not Available
MSD
Mexico City,
MexicoSite Not Available
Merck Sharp & Dohme (New Zealand) Ltd.
Wellington,
New ZealandSite Not Available
MSD Norge A/S
Drammen,
NorwaySite Not Available
Merck Sharp & Dohme, Peru S.R.L.
Lima,
PeruSite Not Available
Call for Information (Investigational Site 0203)
Caguas, 00725
Puerto RicoSite Not Available
Call for Information (Investigational Site 0207)
Cidra, 00739
Puerto RicoSite Not Available
Call for Information (Investigational Site 0202)
Manati, 00674
Puerto RicoSite Not Available
Call for Information (Investigational Site 0204)
Ponce, 00716
Puerto RicoSite Not Available
Merck Sharp & Dohme Romania SRL
Bucharest,
RomaniaSite Not Available
Merck Sharp & Dohme IDEA, Inc.
Moscow,
Russian FederationSite Not Available
MSD (Pty) LTD South Africa
Midrand,
South AfricaSite Not Available
Merck Sharp and Dohme de Espana S.A.
Madrid,
SpainSite Not Available
Merck Sharp & Dohme Ltd.
Hoddesdon,
United KingdomSite Not Available
Call for Information (Investigational Site 0029)
Chandler, Arizona 85224
United StatesSite Not Available
Call for Information (Investigational Site 0006)
Mesa, Arizona 85206
United StatesSite Not Available
Call for Information (Investigational Site 0044)
Little Rock, Arkansas 72205-3199
United StatesSite Not Available
Call for Information (Investigational Site 0055)
Huntington Park, California 90255
United StatesSite Not Available
Call for Information (Investigational Site 0069)
Los Angeles, California 90036
United StatesSite Not Available
Call for Information (Investigational Site 0009)
Mission Hills, California 91345
United StatesSite Not Available
Call for Information (Investigational Site 0008)
Norwalk, California 90650
United StatesSite Not Available
Call for Information (Investigational Site 0011)
San Marino, California 91108
United StatesSite Not Available
Call for Information (Investigational Site 0041)
Simi Valley, California 93065
United StatesSite Not Available
Call for Information (Investigational Site 0030)
Spring Valley, California 91978
United StatesSite Not Available
Call for Information (Investigational Site 0027)
Colorado Springs, Colorado 80909
United StatesSite Not Available
Call for Information (Investigational Site 0074)
Denver, Colorado 80246
United StatesSite Not Available
Call for Information (Investigational Site 0051)
Bridgeport, Connecticut 06610
United StatesSite Not Available
Call for Information (Investigational Site 0028)
Cooper City, Florida 33024
United StatesSite Not Available
Call for Information (Investigational Site 0001)
Debary, Florida 32713
United StatesSite Not Available
Call for Information (Investigational Site 2506)
Hialeah, Florida 33012
United StatesSite Not Available
Call for Information (Investigational Site 0007)
Jacksonville, Florida 32256
United StatesSite Not Available
Call for Information (Investigational Site 0082)
Miami, Florida 33143
United StatesSite Not Available
Call for Information (Investigational Site 0042)
Ocala, Florida 34471
United StatesSite Not Available
Call for Information (Investigational Site 0001)
Orlando, Florida 32806
United StatesSite Not Available
Call for Information (Investigational Site 0065)
Palm Coast, Florida 32164
United StatesSite Not Available
Call for Information (Investigational Site 0090)
Sweetwater, Florida 33172
United StatesSite Not Available
Call for Information (Investigational Site 0060)
Dalton, Georgia 30720
United StatesSite Not Available
Call for Information (Investigational Site 0005)
Savannah, Georgia 31406
United StatesSite Not Available
Call for Information (Investigational Site 0048)
Avon, Indiana 46123
United StatesSite Not Available
Call for Information (Investigational Site 2508)
Indianapolis, Indiana 46260
United StatesSite Not Available
Call for Information (Investigational Site 0088)
Covington, Kentucky 41011
United StatesSite Not Available
Call for Information (Investigational Site 0057)
Crowley, Louisiana 70526
United StatesSite Not Available
Call for Information (Investigational Site 2501)
Monroe, Louisiana 71203
United StatesSite Not Available
Call for Information (Investigational Site 0046)
Sunset, Louisiana 70584
United StatesSite Not Available
Call for Information (Investigational Site 0066)
Portland, Maine 04101
United StatesSite Not Available
Call for Information (Investigational Site 0016)
Elkridge, Maryland 21075
United StatesSite Not Available
Call for Information (Investigational Site 0067)
St. Louis, Missouri 63122
United StatesSite Not Available
Call for Information (Investigational Site 0020)
Canal Fulton, Ohio 44614
United StatesSite Not Available
Call for Information (Investigational Site 2500)
Centerville, Ohio 45459
United StatesSite Not Available
Call for Information (Investigational Site 0002)
Columbus, Ohio 43215
United StatesSite Not Available
Call for Information (Investigational Site 0019)
Lyndhurst, Ohio 44124
United StatesSite Not Available
Call for Information (Investigational Site 0023)
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
Call for Information (Investigational Site 0075)
Lansdale, Pennsylvania 19446
United StatesSite Not Available
Call for Information (Investigational Site 0003)
Pittsburgh, Pennsylvania 15236
United StatesSite Not Available
Call for Information (Investigational Site 0054)
Uniontown, Pennsylvania 15401
United StatesSite Not Available
Call for Information (Investigational Site 0106)
Franklin, Tennessee 37067
United StatesSite Not Available
Call for Information (Investigational Site 0040)
Kingsport, Tennessee 37660
United StatesSite Not Available
Call for Information (Investigational Site 2510)
Nashville, Tennessee 37211
United StatesSite Not Available
Call for Information (Investigational Site 0087)
Smyrna, Tennessee 37167
United StatesSite Not Available
Call for Information (Investigational Site 0034)
Dallas, Texas 75254
United StatesSite Not Available
Call for Information (Investigational Site 0050)
Fort Worth, Texas 76104
United StatesSite Not Available
Call for Information (Investigational Site 0092)
Houston, Texas 77008
United StatesSite Not Available
Call for Information (Investigational Site 0097)
San Antonio, Texas 78258
United StatesSite Not Available
Call for Information (Investigational Site 0031)
Norfolk, Virginia 23510
United StatesSite Not Available
Call for Information (Investigational Site 0018)
Richmond, Virginia 23114
United StatesSite Not Available
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