Efficacy and Safety of Fixed‐Dose Combinations of Sitagliptin and Empagliflozin as Add‐On to Metformin in Korean Patients With Type 2 Diabetes: A Randomised, Double‐Blind, Multi‐Centre, Placebo‐Controlled, Phase III Trial
Authors' conclusion
Sitagliptin/empagliflozin FDC doses achieved improvements in glycaemic control at 24 weeks, which was maintained through 52 weeks. These benefits were accompanied by a favourable safety profile, including a very low risk of hypoglycaemia.
Study context
- Population
- Adults with T2D inadequately controlled by metformin (≥ 1000 mg/day) and sitagliptin (100 mg)randomised 1:1:1
- Participants
- 230 adults
- Comparison
- Sitagliptin/empagliflozin FDC (empagliflozin 10 mg or 25 mg) vs placebo, add-on to metformin and sitagliptin
- E10n = 77
- E25n = 76
- Placebon = 77reference
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 24
Methodological detailsdouble-blind, placebo-controlled, multicentre, phase III, 24-week treatment followed by a 28-week extension period
- Double-blind
- Placebo-controlled
- Multicentre
- Phase III
- 24-week treatment followed by a 28-week extension period
Primary result
As reported in the abstract
Change in HbA1c
Each group vs placeboLeast square mean difference, % (95% CI)P value
E10
−0.54(−0.78 to −0.29)
P < 0.0001E25
−0.61(−0.85 to −0.36)
P < 0.0001Further findings
Fasting plasma glucose (FPG), insulin resistance, body weight, systolic blood pressure, albumin-creatinine ratio, HDL-C
- Also improved in the active groups
HbA1c, FPG and insulin resistance · Week 52
- Reductions sustained
Safety
- Favourable safety profiles; adverse events similar in frequency; no increased hypoglycaemia risk
Original publication
Efficacy and Safety of Fixed‐Dose Combinations of Sitagliptin and Empagliflozin as Add‐On to Metformin in Korean Patients With Type 2 Diabetes: A Randomised, Double‐Blind, Multi‐Centre, Placebo‐Controlled, Phase III Trial. Diabetes Obes Metab. Published 26 March 2026. doi:10.
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