Phase
Condition
Diabetes Prevention
Diabetes And Hypertension
Hypertriglyceridemia
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