Randomization and study intervention
Diabetes
DIABETES
As this was a prospective observational extension study of the UTOPIA trial, no randomization was conducted, and no drug or treatment was prohibited or restricted in this study. In the main UTOPIA study, the enrolled subjects were randomly assigned to a tofogliflozin treatment group or a conventional treatment group without SGLT2 inhibitors. In the tofogliflozin group, 20 mg of tofogliflozin once daily was started in addition to the ongoing therapy. However, the addition of an alternative antidiabetic agent (excluding another SGLT2 inhibitor) was permitted 12 weeks after randomization. In the conventional treatment group, either the dosage of the ongoing therapy was increased, or a concomitant oral glucose-lowering drug (excluding any other SGLT2 inhibitor) was added 12 weeks after randomization. Treatment was continued to achieve the target value specified in the Japanese Treatment Guide for Diabetes [