In the treatment of patients with uncontrolled type 2 diabetes (T2D), adding empagliflozin to the combination of metformin plus evogliptin improves glycaemic control and other metabolic outcomes, as shown in a phase III study conducted in South Korea.
Over 24 weeks, patients who received add-on therapy with empagliflozin at either the 10- or 25-mg dose achieved rapid and sustained reduction in HbA1c, whereas those who received placebo had a slight increase, reported study author Dr Hae Kyung Kim from Yonsei University College of Medicine, Seoul, South Korea, at the annual EASD meeting.
The mean change in HbA1c from baseline to week 24 was –0.54 percent in the empagliflozin 10-mg group and –0.70 percent in 25-mg group vs 0.08 percent in the placebo group (between-group differences, –0.62 percent and –0.77 percent, respectively; p<0.0001 for both). [EASD 2026, abstract 739]
Significant decreases in fasting plasma glucose were seen in the empagliflozin groups vs the placebo group (–28.6 mg/dL with 10 mg and –29.26 mg/dL with 25 mg vs 6.89 mg/dL), and a markedly higher proportion of participants receiving the 25-mg dose achieved the HbA1c target of <7 percent (45.28 percent vs 24.53 percent in the placebo group; p=0.0142).
Compared with placebo, add-on empagliflozin therapy was also associated with significant improvements in the following parameters: body weight (–2.01 kg with 10 mg and –2.41 kg with 25 mg vs –0.82 kg with placebo; p=0.0023 and p<0.0001, respectively), systolic blood pressure (–3.12 mm Hg with 10 mg and –2.09 mm Hg with 25 mg vs 2.15 mm Hg; p=0.0114 and p<0.0388, respectively), adiponectin levels (0.5 µg/mL with 25 mg vs –0.16 µg/mL with placebo; p=0.0100), γ-glutamyl transferase (–8.67 U/L with 10 mg and –7.03 with 25 mg vs 11.68 U/L; p=0.0224 and p=0.0358, respectively), and uric acid (–0.28 mg/dL with 10 mg and –0.40 mg/dL with 25 mg vs 0.13 mg/dL; p=0.0063 and p=0.0004, respectively).
In terms of safety, Kim noted that the overall tolerability profile of empagliflozin was “excellent.”
Treatment-emergent adverse events occurred in 26.3 percent of participants in the empagliflozin 10-mg group, 19 percent in the 25-mg group, and 22.4 percent in the placebo group. None of the participants experienced hypoglycaemic events.
“These results confirm the clinical efficacy and safety of a triple therapy approach, supporting the use of a single-tablet triple fixed-dose combination of metformin, evogliptin, and empagliflozin to simplify complex treatment regimens and improve outcomes in patients with T2D,” Kim said.
Simplifying treatment regimens is crucial, she added, because “pill burden remains a significant barrier to treatment adherence.”
The study included 170 T2D patients (mean age 62.7 years, 50.6 percent male, 25.3 kg/m2) with HbA1c between 7 percent and 10.5 percent for at least 8 weeks despite receiving stable doses of metformin (≥1,000 mg/day) and evogliptin (5 mg/day). At baseline, HbA1c was 7.7 percent, and estimated glomerular filtration rate was 92.1 mL/min/1.73 m2.
The patients were randomly assigned to receive empagliflozin 10 mg (n=57) or 25 mg (n=58) or placebo (n=59) as an add-on to their current dual therapy for 24 weeks. The primary endpoint was the change from baseline in HbA1c at week 24. Secondary endpoints included changes in fasting plasma glucose, HbA1c response rates, and metabolic markers.