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Introduction Most data demonstrating the efficacy and safety of luseogliflozin (luseo) in people with type 2 diabetes mellitus (T2DM) originate from the Japanese population. This study evaluated luseo versus placebo (PCB) as add-on to metformin in a Caucasian population with inadequately controlled T2DM.Research design and methods This was a multicenter, randomized, double-blind, PCB-controlled, parallel-group study. Patients aged 18–75 years with inadequately controlled T2DM (glycated hemoglobin (HbA1c) ≥7% to ≤10% (≥53 to ≤86 mmol/mol)) despite a diet and exercise program and on a stable metformin regimen were eligible. Patients were randomized to one of three luseo groups (2.5, 5.0 and 10.0 mg) or PCB for 12 weeks (W12). The primary endpoint was change in HbA1c expressed as least-square means from baseline (W0) to W12.Results A total of 328 patients were randomized: PCB (n=83) and luseo 2.5 mg (n=80), 5.0 mg (n=86), and 10.0 mg (n=79). Mean age (±SD) was 58.5±8.8 years; 64.6% were women; body mass index was 31.5±3.4 kg/m2; and HbA1c was 8.54±0.70. At W12, mean reductions in HbA1c from W0 were −0.98%, −1.09%, −1.18%, and −0.73% in the luseo 2.5, 5.0 and 10.0 mg, and PCB groups, respectively, all of which were statistically significant. Compared with PCB, HbA1c levels were significantly decreased by 0.25% (p=0.045), 0.36% (p=0.006), and 0.45% (p=0.001) in the luseo 2.5, 5.0, and 10.0 mg groups, respectively. In all luseo dose groups, reductions in body weight were statistically significant compared with PCB. Data from the safety analysis were consistent with the known luseo safety profile.Conclusions All doses of luseo as add-on to metformin in Caucasian patients with uncontrolled T2DM demonstrated significant efficacy in decreasing HbA1c after W12 of treatment.Trial registration number ISRCTN39549850.