A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin

This is a randomized (the study medication is assigned by chance), double-blind (neither
physician nor participant knows the identity of the assigned treatment), placebo-controlled
(an inactive substance that is compared with a study drug, to test whether the study drug
has a real effect), multicenter study of efficacy, safety, and tolerability of canagliflozin
in participants with T2DM, who have inadequate glycemic (blood sugar) control on maximally
or near-maximally effective doses of metformin >=1500 mg/day and sitagliptin 100 mg/day.
Approximately 200 participants will be randomly assigned to 1 of 2 treatment groups in 1:1
ratio for 26 weeks. During the study the participants will be also provided with diet and
exercise counseling (standardized non-pharmacological therapy).

Inclusion Criteria:

- Must have a diagnosis of type 2 diabetes mellitus

- Must have a screening HbA1c of >=7.5% to <=10.5%

- Must be on metformin >=1500 mg/day and sitagliptin 100 mg/day (or equivalent fixed
dose combination) at a stable dose for at least 12 weeks before screening

Exclusion Criteria:

- History of diabetic ketoacidosis or T1DM, hereditary glucose-galactose malabsorption
or primary renal glycosuria

- A myocardial infarction, unstable angina, revascularization procedure or
cerebrovascular accident within 12 weeks before screening

- eGFR <60 ml/min/1.73m2, or serum creatinine >=1.4 mg/dL for men and >=1.3 mg/dL for
women

- Known significant liver disease (eg, acute hepatitis, chronic active hepatitis,
cirrhosis)

- Major surgery (ie, requiring general anesthesia) within 12 weeks before screening