An Ju-Hyun, Ko Byung-Gee, Namkung Hyun, Lee Hye-Gyu, Lim Hyun-Woo, Huh Wan, Park Joon Seok, Moon Jae-Bong, Youn Hwa-Young, Ryu Min-Ok
Department of Veterinary Emergency and Critical Care Medicine, Institute of Veterinary Science, College of Veterinary Medicine, Kangwon National University, Chuncheon, Republic of Korea.
Laboratory of Internal Medicine, Department of Veterinary Clinical Science, College of Veterinary Science, Seoul National University, Seoul, 08826, Republic of Korea.
BMC Vet Res. 2025 Aug 12;21(1):512. doi: 10.1186/s12917-025-04962-y.
Sodium-glucose cotransporter 2 inhibitors are widely used in human medicine for their insulin-independent glucose-lowering effects. However, their clinical efficacy and safety for managing diabetes mellitus in dogs have not been established. This study aimed to evaluate the efficacy and safety of DWP16001, a selective sodium-glucose cotransporter 2 inhibitor, as an adjunct to insulin therapy for client-owned dogs with diabetes mellitus.
This multicenter, randomized, double-blind, placebo-controlled clinical trial involved 61 dogs receiving stable insulin therapy. They were randomly assigned to receive DWP16001 (0.025 mg/kg PO q24h) or placebo for 8 weeks. The changes in the serum fructosamine (weeks 0, 1, 4, and 8) and HbA1c (weeks 0, 4 and 8) concentrations and daily insulin dose were assessed. Safety evaluations included adverse event monitoring, physical examination, body weight measurement, blood gas and ketone analyses, urinalysis, and hematologic and biochemical profiling. Hypoglycemia was detected via blood glucose curve.
DWP16001 significantly reduced fructosamine and HbA1c concentrations in the dogs, especially in those with poor baseline glycemic control (fructosamine ≥ 500 µmol/L, HbA1c ≥ 6%). A trend toward reduced insulin requirements was observed in the treatment group without significant weight loss or clinically relevant changes in systolic blood pressure or signs of volume depletion. Asymptomatic hypoglycemia was detected in four dogs receiving DWP16001, but it resolved following insulin dose adjustment. No episodes of diabetic ketoacidosis were recorded, and laboratory parameters remained stable throughout the study.
DWP16001 is a safe and effective adjunct to insulin therapy for diabetic dogs, especially those with suboptimal glycemic control. It demonstrated insulin-sparing effects and favorable metabolic safety, necessitating further evaluation in long-term clinical studies.
钠-葡萄糖协同转运蛋白2抑制剂因其不依赖胰岛素的降糖作用而在人类医学中被广泛使用。然而，它们在治疗犬糖尿病方面的临床疗效和安全性尚未确立。本研究旨在评估选择性钠-葡萄糖协同转运蛋白2抑制剂DWP16001作为胰岛素治疗的辅助药物用于患有糖尿病的家养犬的疗效和安全性。
这项多中心、随机、双盲、安慰剂对照的临床试验纳入了61只接受稳定胰岛素治疗的犬。它们被随机分配接受DWP16001（0.025mg/kg口服，每24小时一次）或安慰剂，为期8周。评估血清果糖胺（第0、1、4和8周）和糖化血红蛋白A1c（第0、4和8周）浓度以及每日胰岛素剂量的变化。安全性评估包括不良事件监测、体格检查、体重测量、血气和酮体分析、尿液分析以及血液学和生化指标检测。通过血糖曲线检测低血糖。
DWP16001显著降低了犬的果糖胺和糖化血红蛋白A1c浓度，尤其是那些基线血糖控制不佳的犬（果糖胺≥500μmol/L，糖化血红蛋白A1c≥6%）。在治疗组中观察到胰岛素需求量有降低的趋势，且没有明显的体重减轻，收缩压也没有出现临床相关变化或容量耗竭的迹象。在接受DWP16001的4只犬中检测到无症状低血糖，但在调整胰岛素剂量后得到缓解。未记录到糖尿病酮症酸中毒事件，并且在整个研究过程中实验室参数保持稳定。
DWP16001作为胰岛素治疗糖尿病犬的辅助药物是安全有效的，尤其是对于血糖控制欠佳的犬。它显示出节省胰岛素的作用和良好的代谢安全性，需要在长期临床研究中进一步评估。
