A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus

Canagliflozin is a drug that is being tested to see if it may be useful in treating patients
diagnosed with type 2 diabetes mellitus (T2DM). This is a randomized (study drug assigned by
chance), double-blind (neither the patient or the study doctor will know the name of the
assigned treatment), placebo-controlled, parallel-group, 3-arm (3 treatment groups)
multicenter study to determine the efficacy, safety, and tolerability of canagliflozin (100
mg and 300 mg) compared to placebo (a capsule that looks like all the other treatments but
has no real medicine) in patients with T2DM who are not achieving an adequate response from
current antihyperglycemic therapy to control their diabetes. Approximately 720 older (55 to
80 years of age) patients with T2DM who are either not on an antihyperglycemic agent or who
are receiving treatment with a stable regimen of antihyperglycemic agent(s) and have
inadequate glycemic (blood sugar) control will receive once daily treatment with
canagliflozin (100 mg or 300 mg) or placebo capsules for 104 weeks (includes 26 weeks of
double-blind treatment followed by a 78-week extension period). In addition, all patients
will take stable doses of the antihyperglycemic agent(s) that they were taking before entry
in the study for the duration of the study. Patients will participate in the study for
approximately 108 weeks. During the study, if a patient's fasting blood sugar remains high
despite treatment with study drug, the patient will receive treatment with an
antihyperglycemic agent (rescue therapy) that is considered clinically appropriate and
consistent with local prescribing information. During treatment, patients will be monitored
for safety by review of adverse events, results from laboratory tests, measures of bone
health, 12-lead electrocardiograms (ECGs), vital signs measurements, body weight, physical
examinations, and self-monitored blood glucose (SMGB) measurements. The primary outcome
measure in the study is the effect of canagliflozin relative to placebo on hemoglobin A1c
(HbA1c) after 26 weeks of treatment. Study drug will be taken orally (by mouth) once daily
before the first meal each day unless otherwise specified. All patients will take
single-blind placebo capsules for 2 weeks before randomization. After randomization,
patients will take double blind canagliflozin (100 mg or 300 mg) or matching placebo for 104
weeks.