A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents With Type 2 Diabetes Mellitus

The participants who meet the eligibility criteria, will receive a single dose of placebo
(an inactive substance that is compared with a drug to test whether the drug has a real
effect in a clinical trial) and this will be followed by baseline 24 hour pharmacodynamic
assessments. On the next morning participants will receive the first canagliflozin dose and
will be discharged home to continue canagliflozin treatment for 13 additional days. There
will be 2 treatment groups (8 participants in each): the first group will receive
canagliflozin 100 mg daily, the second group will receive either canagliflozin 300 mg or
canagliflozin 50 mg daily. The canagliflozin dose for the second treatment group will be
determined after the sponsor has evaluated the results from the first 5 participants. On day
14 of treatment the participants will be admitted again for 24 hour pharmacokinetic and
pharmacodynamics assessments. The participants will continue to take their normal dose and
schedule of metformin during the entire study. The total duration of the study is
approximately 50 days.

Inclusion Criteria:

- Diagnosed with Type 2 Diabetes Mellitus

- Be on a stable regimen of metformin immediate release (IR) monotherapy of at least
1,000 mg/day for at least 8 weeks before screening

- Able to swallow whole tablets

- Absence of pancreatic autoimmunity

- Participants and their caregivers must agree to perform the fasting fingerstick
glucose self-monitoring during the study

Exclusion Criteria:

- History of Type 1 diabetes mellitus

- History of maturity onset diabetes of the young (MODY) and any secondary form of
diabetes

- Current clinically significant medical illness e.g., significant pulmonary disease,
renal or hepatic insufficiency, uncontrolled thyroid disease

- Systolic or diastolic blood pressure outside the range considered normal for the
participant sex, age and height

- For females, participants will be excluded if pregnant