Safety and Efficacy of Ertugliflozin in the Treatment of Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin (MK-8835-006)

The duration of the trial will be approximately 69 weeks. This will include a 1-week
Screening Period, an up to 12-week wash-off/titration /dose-stabilization period, a 2-week
single-blind, placebo run-in period, a 52-week double-blind, placebo-controlled treatment
period (including a 26-week Phase A and 26-week Phase B), and a post-treatment telephone
contact 14 days after the last dose of blinded investigational product.

Inclusion Criteria:

- Diagnosis of type 2 diabetes mellitus (T2DM)

- On stable diabetes therapy of metformin with either sitagliptin or another dipeptidyl
peptidase-4 (DPP-4) inhibitor or a sulfonylurea (SU) prior to study participation and
is willing to wash-off/switch from another DPP-4 inhibitor/SU to sitagliptin

- Body Mass Index (BMI) greater than or equal to 18.0 kg/m^2

- Male, postmenopausal female or surgically sterile female

- If a female of reproductive potential, agrees to remain abstinent or to use (or have
their partner use) 2 acceptable combinations of birth control while participating in
the trial and for 14 days after the last use of study drug

Exclusion Criteria:

- 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 endocrine disorders, drug- or chemical-induced,
and post-organ transplant)

- A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2
(SGLT2) or DPP-4 inhibitor

- On a weight-loss program or weight-loss medication or other medication associated
with weight changes and is not weight stable

- Has undergone bariatric surgery within the past 12 months or >12 months and is not
weight stable

- Has been treated with insulin (except for short-term use [<= 7 days]), injectable
antihyperglycemic agents (AHAs) (e.g., pramlintide, exenatide, liraglutide),
pioglitazone or rosiglitazone, other sodium-glucose co-transporter 2 (SGLT2)
inhibitors, alpha glucosidase inhibitors or meglitinides, bromocriptine (Cycloset™),
colesevelam (Welchol™), or any other nonapproved AHAs within 12 weeks of study
participation

- Has active, obstructive uropathy or indwelling urinary catheter

- 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 participation

- A history of malignancy ≤5 years prior to study participation, except for adequately
treated basal or squamous cell skin cancer or in situ cervical cancer

- Known history of Human Immunodeficiency Virus (HIV)

- Has blood dyscrasias or any disorders causing hemolysis or unstable red blood cells
or any other clinically significant hematological disorder (such as aplastic anemia,
myeloproliferative or myelodysplastic syndromes, thrombocytopenia)

- A medical history of active liver disease (other than nonalcoholic hepatic
steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or
active symptomatic gallbladder disease

- Has any clinically significant malabsorption condition

- If taking thyroid replacement therapy, has not been on a stable dose for at least 6
weeks prior to study participation

- Has been previously randomized in a study with ertugliflozin

- Has participated in other studies involving an investigational drug within 30 days
prior or during study participation

- Has undergone a surgical procedure within 6 weeks prior to or planned major surgery
during study participation

- Has a positive urine pregnancy test

- Is pregnant or breast-feeding, or is planning to conceive during the trial, including
14 days following the last dose of study medication

- Planning to undergo hormonal therapy in preparation to donate eggs during the trial,
including 14 days following the last dose of study medication

- Excessive consumption of alcoholic beverages or binge drinking

- Has donated blood or blood products within 6 weeks of study participation or plans to
donate blood or blood products at any time during the trial