effect of renal impairment on the pharmacokinetics, pharmacodynamics, safety and tolerability of ertugliflozin in participants with type 2 diabetes mellitus (mk-8835-009)

Conditions: Renal Impairment; Type 2 Diabetes Mellitus

Summary: this is a study to evaluate the effect of renal impairment on the pharmacokinetics, pharmacodynamics, safety and tolerability of ertugliflozin in participants with type 2 diabetes mellitus (t2dm) and in healthy participants with normal renal function.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of approximately 18 to 40 kg/m\^2 * stable renal function * male or female not of reproductive potential * female of reproductive potential must agree or have their partner agree to use 2 acceptable methods of contraception * healthy subjects determined to be healthy by investigator screening * t2dm participants have a diagnosis of t2dm as per american diabetes association guidelines * t2dm participants to be on a stable anti-hyperglycemic regimen with no new drug or drug dosage within 8 weeks of study participation. variations in daily dose of insulin up to 10% are permitted. exclusion criteria: * a positive urine drug screen for drugs of abuse or recreational drugs * pregnant or nursing females * history of abuse of alcohol or illicit drugs * significant renal or urinary disease within 6 months of study participation * history of malignancy within the past 5 years basal cell carcinoma of the skin or cervical cancer in situ * history of human immunodeficiency virus (hiv) * history of blood dyscrasias or any disorders causing hemolysis or unstable red blood cells * any acute disease state (eg, , vomiting, fever, diarrhea) within 7 days before study participation * treatment with an investigational drug within 30 days of study participation * use of herbal supplements within 28 days prior to study participation * any clinically significant malabsorption condition * blood donation (excluding plasma donations) of approximately 1 pint within 56 days prior to study participation * history of sensitivity to ertugliflozin or other sodium-glucose co-transporter 2 (sglt2) inhibitors * history of sensitivity to heparin or heparin-induced thrombocytopenia * unwilling or unable to comply with the study lifestyle guidelines * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease including clinically relevant and significant drug allergies * use of prescription drugs (hormonal methods of birth control are allowed), vitamins and dietary supplements within 7 days of study participation * for t2dm participants, history of type 1 diabetes mellitus or a history of ketoacidosis * for t2dm participants, clinically significant electrocardiogram abnormality * for t2dm participants, history of myocardial infarction, unstable angina, coronary revascularization, stroke or transient ischemic attack within 3 months of study participation * for t2dm participants, heart failure defined as new york heart association functional class iii-iv * for t2dm participants, renal allograft recipients * for t2dm participants, requiring dialysis * for t2dm participants, strict fluid restriction * for t2dm participants, urinary incontinence * for t2dm participants, acute renal disease * for t2dm participants, significant hepatic, cardiac, or pulmonary disease or clinically nephrotic * for t2dm participants, prescription and over-the-counter medication that is not taken according to a stable regimen for 7 days before study participation * for t2dm participants, on metformin should not be enrolled if their baseline renal function is outside the approved product labeling * for t2dm participants receiving any of the following medications within 7 days of study participation: 1. other sglt2 inhibitors (eg, dapagliflozin, canagliflozin, empagliflozin); 2. other injectable anti-hyperglycemic agents including pramlintide or glucagon-like peptide-1 (glp-1) analogues; 3. any immunosuppressive drugs, including cyclosporine, tacrolimus, sirolimus; 4. oral corticosteroids (note that inhaled, nasal and topical corticosteroids are permitted); 5. any potent drug-metabolizing enzyme-inducing drug, including rifampin, phenytoin, and carbamazepine; 6. probenecid, valproic acid, gemfibrozil.