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
Abstract
AIMS
This study evaluated the efficacy and safety of anagliptin added to metformin and empagliflozin in patients with type 2 diabetes (T2DM) inadequately controlled on dual therapy.
METHODS
In this multicenter, randomized, double-blind, placebo-controlled phase 3 trial, patients with T2DM (HbA1c 7.0-11.0 %) on metformin (≥1000 mg/day) and empagliflozin (25 mg/day) were randomized 1:1 to anagliptin (100 mg twice daily) or placebo for 24 weeks, followed by a 28-week open-label extension. The primary endpoint was HbA1c change from baseline to week 24.
RESULTS
Of 200 randomized patients, 197 were analyzed (baseline HbA1c 7.76 %). At week 24, the least-squares mean HbA1c change was -0.83 % with anagliptin versus -0.03 % with placebo (difference -0.80 %; 95 % CI - 0.95 to - 0.64; P < 0.0001). The least-squares mean change in HOMA-β was + 10.45 versus -6.02 with placebo (between-group difference 16.46; P = 0.0003). Adverse events were similar between groups, with no severe hypoglycemia or deaths.
CONCLUSIONS
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.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 200 participants or records.
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