ABOUT THIS STUDY
- Asian participants ≥18 years of age at the time of initial Screening.
- Type 2 diabetes mellitus as per American Diabetes Association guidelines.
- Metformin monotherapy (≥1500 mg/day) with an initial Screening A1C of 7.0-10.5% (53-91 mmol/mol) OR metformin monotherapy (<1500 mg/day) with an initial Screening A1C of 7.5-11.0% (58-97 mmol/mol) OR dual combination therapy with metformin + sulfonylurea, dipeptidyl peptidase-4 (DDP-4) inhibitor, meglitinide, or alpha-glucosidase inhibitor with an initial Screening A1C of 6.5-9.5% (48-80 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 heterosexual activity or to use 2 acceptable combinations of contraception.
- History of type 1 diabetes mellitus or a history of ketoacidosis.
- History of other specific types of diabetes (e.g., genetic syndromes, secondary
pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and
- History of myocardial infarction, unstable angina, arterial revascularization, stroke,
transient ischemic attack, or New York Heart Association (NYHA) functional class
III-IV heart failure within 3 months of study start.
- Mean value for triplicate screening sitting systolic blood pressure >160 mm Hg and/or
diastolic blood pressure >90 mm Hg after at least a 5-minute seated rest at screening
- Active, obstructive uropathy or indwelling urinary catheter.
- History of malignancy ≤5 years prior to study start, except for adequately treated
basal cell or squamous cell skin cancer or in situ cervical cancer.
- Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week or
engages in binge drinking.
- Any clinically significant malabsorption condition.
- Is on a weight-loss program or weight-loss medication or other medication associated
with 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 not
weight stable prior to study start.
- A known hypersensitivity or intolerance to any sodium glucose co-transporter (SGLT2)
- On a previous clinical study with ertugliflozin.
- Is taking blood pressure or lipid altering medications that have not been on a stable
dose for at least 4 weeks prior to study start.
- Current treatment for hyperthyroidism.
- Male participants with a serum creatinine >=1.3 mg/dL (>=115 mol/L) or female
participants with a serum creatinine >=1.2 mg/dL (>=106 mol/L) or participants with an
estimated glomerular filtration rate (eGFR) <55 mL/min/1.73m^2 according to the
4-variable Modification of Diet in Renal Disease (MDRD) equation at screening.
- An aspartate transaminase (AST) or alanine transaminase (ALT) >2X the upper limit of
normal (ULN) range at screening, or a total bilirubin >1.5 X the ULN unless the
participant has a history of Gilbert's.
- On thyroid replacement therapy and has not been on a stable dose for at least 6 weeks
prior to study start.
- A medical history of active liver disease (other than non-alcoholic hepatic
steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or
symptomatic gallbladder disease.
- Has been treated with any of the following agents within 12 weeks of study start or
during the pre-randomization period: Insulin of any type (except for short-term use
during concomitant illness or other stress), other injectable anti-hyperglycemic
agents (e.g., pramlintide, exenatide, liraglutide), another SGLT2 inhibitor,
bromocriptine, colesevelam, rosiglitazone or pioglitazone, or any other AHA with the
exception of the protocol-approved agents.
- Is on or likely to require treatment ≥14 consecutive days or repeated courses of
pharmacologic doses of corticosteroids.
- Has undergone a surgical procedure within 6 weeks prior to study start or has planned
major surgery during the study.
- Pregnant or breast-feeding, or planning to conceive during the trial, including 14
days 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.
- Donated blood or blood products within 6 weeks of study start.
- Has Human Immunodeficiency Virus (HIV).
- Has blood dyscrasias or any disorders causing hemolysis or unstable red blood cells.
- Has clinically important hematological disorders (such as aplastic anemia,
myeloproliferative or myelodyplastic syndromes, thrombocytopenia.)
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