Efficacy and safety of combining empagliflozin in people with type 2 diabetes mellitus uncontrolled with metformin and sitagliptin: A randomised, double‐blind, multicentre, therapeutic confirmatory phase 3 clinical trial
Authors' conclusion
These results suggest that coadministration of empagliflozin safely improves glycemic control in Korean patients with T2DM uncontrolled by sitagliptin and metformin.
Study context
- Population
- Patients with T2DM uncontrolled (HbA1c 7%-10%) after ≥8 weeks of metformin and sitagliptin
- Participants
- 172 patients
- Comparison
- Empagliflozin 10 mg or 25 mg vs placebo as add-on to metformin and sitagliptin
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 24
Methodological detailsdouble-blind, multicentre, therapeutic confirmatory, phase 3
- Double-blind
- Multicentre
- Therapeutic confirmatory
- Phase 3
Primary result
As reported in the abstract
Change in HbA1c · 24 weeks
Each group vs placeboAdjusted mean difference, % (95% CI)P value
Empagliflozin 10 mg
−0.7(−1.0 to −0.4)
P < 0.0001Empagliflozin 25 mg
−0.8(−1.1 to −0.5)
P < 0.0001Further findings
FPG · 24 weeks
- FPG significantly decreased in both empagliflozin groups vs placebo
- both p <.0001
HbA1c <7% or <6.5% · 24 weeks
- More patients reached HbA1c <7% or <6.5% with empagliflozin 10 and 25 mg vs placebo
- both p <.05
Durability of efficacy · 28-week extension
- Efficacy maintained in the empagliflozin groups during the 28-week extension
Albuminuria and body weight
- Empagliflozin add-on associated with improvements in albuminuria and body weight
Safety
- Incidence of adverse events similar across groups; add-on empagliflozin well tolerated
Original publication
Efficacy and safety of combining empagliflozin in people with type 2 diabetes mellitus uncontrolled with metformin and sitagliptin: A randomised, double‐blind, multicentre, therapeutic confirmatory phase 3 clinical trial. Diabetes Obes Metab. Published 19 December 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →