Despite several potential limitations of the current study,
including the relatively small number of patients enrolled in the
study, a generally lower baseline HbA1c in this patient population
compared with those in Phase 3 studies, and a low representation
of some races/ethnicities in the patient population (as a function of
study centers), findings were generally consistent with Phase 3
studies of canagliflozin. Longer-term studies of canagliflozin 50 and
150 mg BID in larger and broader patient populations may be
helpful for further elucidation of the efficacy and safety of canagliflozin
BID dosing regimens. Furthermore, it would be beneficial
to include canagliflozin 100 and 300 mg QD arms in future studies
to allow for direct comparisons of BID and QD dosing.
In conclusion, canagliflozin BID dosing, at total daily doses of 100
and 300 mg, provided significant glycemic efficacy. Reductions in
HbA1c were modest, consistent with the lower baseline HbA1c in
the present study compared with previous Phase 3 studies of canagliflozin.
Reductions in body weight and systolic BP were also
observed, and canagliflozin BID was generally well tolerated as addon
to metformin monotherapy. Overall, findings from this study
indicate a favorable efficacy and safety/tolerability profile of cana