Efficacy and safety of luseogliflozin in Caucasian patients with type 2 diabetes: results from a phase III, randomized, placebo-controlled, clinical trial
Authors' conclusion
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.
Study context
- Population
- Caucasian patients aged 18–75 years with inadequately controlled T2D (HbA1c ≥7% to ≤10%) despite diet and exercise, on stable metformin; mean age 58.5±8.8 years, 64.6% women, BMI 31.5±3.4 kg/m², HbA1c 8.54±0.70randomized
- Participants
- 328 patients
- Comparison
- Luseogliflozin vs placebo as add-on to metformin
- Primary endpoint
- Change in HbA1c (least-square means) from baseline
- Follow-up
- 12 weeks
Methodological detailsphase III, multicenter, double-blind, placebo-controlled, parallel-group
- Phase III
- Multicenter
- Double-blind
- Placebo-controlled
- Parallel-group
Primary result
As reported in the abstract
Change in HbA1c from W0 · W12
Difference
0.25 %
P = 0.045
Luseo 2.5 mg vs placebo (PCB) · HbA1c lower with Luseo 2.5 mg
Difference
0.36 %
P = 0.006
Luseo 5.0 mg vs PCB · HbA1c lower with Luseo 5.0 mg
Difference
0.45 %
P = 0.001
Luseo 10.0 mg vs PCB · HbA1c lower with Luseo 10.0 mg
Luseo 2.5 mg
−0.98
mean · %
Luseo 5.0 mg
−1.09
mean · %
Luseo 10.0 mg
−1.18
mean · %
PCB
−0.73
mean · %
Further findings
- Reductions in body weight statistically significant vs PCB in all luseo dose groups
Safety
- Safety data consistent with the known luseo safety profile
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Efficacy and safety of luseogliflozin in Caucasian patients with type 2 diabetes: results from a phase III, randomized, placebo-controlled, clinical trial. BMJ Open Diabetes Res Care. Published 16 June 2023. doi:10.
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