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Efficacy and safety of a fixed‐dose combination of dapagliflozin and linagliptin ( AJU ‐ A51 ) in patients with type 2 diabetes mellitus: A multicentre, randomized, double‐blind, parallel‐group, placebo‐controlled phase III study

2024; Wiley; Linguagem: Inglês

10.1111/dom.15985

1463-1326

Jun Hwa Hong, Myeong‐Jin Kim, Kyung Wan Min, Jong Chul Won, Tae Nyun Kim, Byung‐Wan Lee, Jun Goo Kang, Jae Hyeon Kim, Jung Hwan Park, Bon Jeong Ku, Chang Beom Lee, Sang Yong Kim, Ho Sang Shon, Woo Je Lee, Joong‐Yeol Park,

Pancreatic function and diabetes

Abstract Aims To evaluate the efficacy and safety of add‐on dapagliflozin in patients with type 2 diabetes mellitus (T2D) who had inadequate glycaemic control with metformin and linagliptin. Materials and Methods A total of 235 patients with inadequate response to metformin (≥1000 mg/day) plus linagliptin (5 mg/day) were randomized to receive either dapagliflozin/linagliptin fixed‐dose combination (FDC [AJU‐A51]) 10/5 mg/day ( n = 117) or linagliptin 5 mg plus placebo ( n = 118) for 24 weeks. After the main treatment period, patients who received linagliptin plus placebo were treated with AJU‐A51 for an additional 28 weeks. Change in glycated haemoglobin (HbA1c) from baseline to Week 24 was the primary endpoint. Results AJU‐A51 significantly reduced HbA1c levels (from 7.93% ± 0.82% to 7.11% ± 0.61%) compared with linagliptin plus placebo (from 7.80% ± 0.71% to 7.87% ± 0.94%), with a least squares mean difference of −0.88% (95% confidence interval −1.07 to −0.68; p < 0.0001) at 24 weeks. The AJU‐A51 group had a significantly higher proportion of patients who achieved HbA1c <7.0% at Week 24 than the control group (44.8% vs. 18.6%; p < 0.001). The AJU‐A51 group maintained glycaemic efficacy up to 52 weeks, whereas the control group showed a substantial reduction in HbA1c after switching to AJU‐A51 in the extension study period. Both groups had similar incidence of treatment‐emergent and serious adverse events, and no cases of symptomatic hypoglycaemia were reported. Conclusions Dapagliflozin and linagliptin FDC (AJU‐A51) showed potent glucose‐lowering effects, with good tolerability, in patients with T2D who had poor glycaemic control on metformin and linagliptin ( ClinicalTrials.gov [NCT06329674]).