Efficacy and safety of anagliptin added to metformin and empagliflozin 25 mg in patients with type 2 diabetes: a 24-week randomized, double-blind, placebo-controlled phase 3 trial with 28-week open-label extension
Primary result · LS mean HbA1c changeResult — go to the resultDifference −0.80 % 95 % CI - 0.95 to - 0.64Authors' conclusion
In this first placebo-controlled trial evaluating DPP-4 inhibitor addition to maximally dosed empagliflozin (25 mg) plus metformin, anagliptin significantly improved glycemic control and β-cell function with a favorable safety profile, supporting this triple combination as an effective intensification strategy.
Study context
- Population
- Patients with T2D (HbA1c 7.0–11.0 %) on metformin (≥1000 mg/day) and empagliflozin (25 mg/day)197 analysed
- Participants
- 200 patients
- Comparison
- Anagliptin vs placebo added to metformin and empagliflozin
- Primary endpoint
- HbA1c change from baseline
- Follow-up
- Week 24
Methodological detailsmulticenter, double-blind, placebo-controlled, phase 3, 28-week open-label extension
- Multicenter
- Double-blind
- Placebo-controlled
- Phase 3
- 28-week open-label extension
Primary result
LS mean HbA1c change
Difference
−0.80 %
95 % CI - 0.95 to - 0.64
P < 0.0001
Change by group
Anagliptin
−0.83
least-squares mean · %
Placebo
−0.03
least-squares mean · %
As reported in the abstract
Further findings
| Outcome | Anagliptin | Placebo | Between-group difference | P value |
|---|---|---|---|---|
| LS mean change in HOMA-β | least-squares mean + 10.45 | least-squares mean −6.02 | 16.46 | P = 0.0003 |
Safety
- Severe hypoglycemia
- 0
- Deaths
- 0
- Adverse events were similar between groups
Original publication
Efficacy and safety of anagliptin added to metformin and empagliflozin 25 mg in patients with type 2 diabetes: a 24-week randomized, double-blind, placebo-controlled phase 3 trial with 28-week open-label extension. Diabetes Res Clin Pract. Published 24 April 2026. doi:10.
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