A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise

This study will be a randomized (the study medication is assigned by chance), double-blind
(neither physician nor participant knows the identity of the assigned treatment),
active-controlled (one of the treatments is an established effective treatment for type 2
diabetes mellitus), parallel-group (each group of participants will be treated at the same
time), 5-arm (groups), multicenter study. Approximately 1,200 participants will be randomly
assigned to the 5 treatment arms in a 1:1:1:1:1 ratio for 26 weeks.

Inclusion Criteria:

- Must have type 2 diabetes mellitus with inadequate glycemic control on diet and
exercise

- Not on antihyperglycemic agent therapy (at least 12 weeks before screening) and have
a screening visit fingerstick glycated hemoglobin (HbA1c) of more than or equal to 7
percent and less than or equal to 12.5 percent

- Have a screening visit HbA1c of more than or equal to 7.5 percent and less than or
equal to 12 percent as determined by the central laboratory

- Must have a fasting plasma glucose of less than or equal to 300 mg/dL (16.7 mmol/L)
prior to randomization

- Must have a fasting fingerstick glucose of greater than 120 mg/dL (6.7 mmol/L)
performed at home or at the study center prior to randomization

Exclusion Criteria:

- History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or
beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy

- Fasting C-peptide less than 0.70 ng/mL (0.23 nmol/L) in participants for whom the
investigator cannot reasonably exclude T1DM based upon clinical evaluation

- Repeated (2 or more over a 1 week period) fasting self-monitored blood glucose
measurements more than 300 mg/dL (16.7 mmol/L) prior to randomization, despite
reinforcement of diet and exercise counseling

- History of hereditary glucose-galactose malabsorption or primary renal glucosuria

- Has history of, or currently active, illness considered to be clinically significant
by the Investigator or any other illness that the Investigator considers should
exclude the patient from the study or that could interfere with the interpretation of
the study results