Primary Objectives:
To assess the effects of tofogliflozin on glycemic control in comparison to placebo as an
add-on treatment to insulin treatment in terms of glycated hemoglobin (HbA1c) reduction over
a period of 16 weeks in patients with type 2 diabetes mellitus.
To assess the safety of tofogliflozin in combination with insulin treatment throughout 52
weeks.
Secondary Objectives:
To assess the effects of tofogliflozin in comparison to placebo on:
- Body weight
- Fasting plasma glucose (FPG)
- Postprandial plasma glucose (PPG) To assess the long term safety and tolerability of
tofogliflozin.