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.

Autor: Hong JH; Department of Internal Medicine, Daejeon Eulji Medical Center, Eulji University, Daejeon, Korea., Kim MJ; Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.; Asan Diabetes Center, Asan Medical Center, Seoul, Korea., Min KW; Department of Internal Medicine, Eulji University School of Medicine, Seoul, Korea., Won JC; Department of Internal Medicine, Sanggye Paik Hospital, Cardiovascular and Metabolic Disease Center, Inje University College of Medicine, Seoul, Korea., Kim TN; Department of Internal Medicine, Cardiovascular and Metabolic Disease Center, Inje University College of Medicine, Busan, Korea., Lee BW; Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea., Kang JG; Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea., Kim JH; Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea., Park JH; Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea., Ku BJ; Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea., Lee CB; Division of Endocrinology and Metabolism, Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea., Kim SY; Department of Internal Medicine, Chosun University Hospital, Chosun University College of Medicine, Gwangju, Korea., Shon HS; Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea., Lee WJ; Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.; Asan Diabetes Center, Asan Medical Center, Seoul, Korea., Park JY; Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.; Asan Diabetes Center, Asan Medical Center, Seoul, Korea.
Jazyk: angličtina
Zdroj: Diabetes, obesity & metabolism [Diabetes Obes Metab] 2025 Jan; Vol. 27 (1), pp. 81-91. Date of Electronic Publication: 2024 Oct 07.
DOI: 10.1111/dom.15985
Abstrakt: 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]).
(© 2024 The Author(s). Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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