Lobeglitazone improves glycaemic control as add‐on therapy to empagliflozin plus metformin in patients with type 2 diabetes mellitus: A double‐blind, randomised, placebo‐controlled trial
Authors' conclusion
Lobeglitazone as an add-on to empagliflozin and metformin significantly improved glycaemic control in patients with T2DM inadequately controlled on metformin and empagliflozin dual therapy. The treatment was well tolerated, with a low incidence of adverse events.
Study context
- Population
- Patients with T2DM inadequately controlled on metformin (≥1000 mg/day) and empagliflozin 10 mg/day (Study 1) or 25 mg/day (Study 2)
- Comparison
- Lobeglitazone 0.5 mg/day vs placebo as add-on to metformin plus empagliflozin
- Primary endpoint
- Change from baseline in HbA1c
- Follow-up
- 24 weeks
Methodological detailsphase 3, multicentre, double-blind, placebo-controlled, 52-week open-label extension (28 weeks)
- Phase 3
- Multicentre
- Double-blind
- Placebo-controlled
- 52-week open-label extension (28 weeks)
Primary result
As reported in the abstract
Lobeglitazone vs PlaceboDifference, % (95% CI)P value
Study 1 (empagliflozin 10 mg/day)
−0.71(−0.88 to −0.55)
P < 0.001Study 2 (empagliflozin 25 mg/day)
−0.62(−0.79 to −0.45)
P < 0.001Further findings
HbA1c <7% (Study 1) · 24 weeks
P < 0.001
HbA1c <7% (Study 2) · 24 weeks
P < 0.001
Safety
Adverse events
- AE incidence numerically different between groups, no statistically significant differences; generally comparable profile
Original publication
Lobeglitazone improves glycaemic control as add‐on therapy to empagliflozin plus metformin in patients with type 2 diabetes mellitus: A double‐blind, randomised, placebo‐controlled trial. Diabetes Obes Metab. Published 14 November 2025. doi:10.
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