背景:治疗猫糖尿病的选择仅限于胰岛素注射和监测低血糖。
目的:每日一次钠-葡萄糖协同转运蛋白2抑制剂velagliflozinPO不劣于胰岛素注射。
方法:客户拥有的糖尿病猫(安全性127;疗效评估116)。
方法:前瞻性,随机(1毫克/千克维格列净),阳性对照(滴定胰岛素),开放标签,非劣效性现场试验,在第45天比较在≥1个临床变量和≥1个血糖变量(边缘Δ:15%)中治疗成功的猫的数量;次要终点包括91天期间的血糖和临床评估。
结果:在第45天,29/54(54%)velagliflozin治疗的猫和26/62(42%)Caninsulin治疗的猫显示治疗成功,表现出非劣效性(差异-11.8%;上侧97.5%置信区间,-∞至6.3%)。到第91天,生活质量(QoL),多尿,多饮改善了81%,54%和61%(velagliflozin);在血糖(BG)曲线上,在42/54(78%;维格列净)和37/62(60%;Caninsular)中,平均BG<252mg/dL;在41/54(76%;维格列净)和41/62(66%;Caninar)中,最低BG<162mg/dL;在41/54(76%;Canliflozin)中,血清果糖胺<450μmol/LVelagliflozin最常见的不良事件是粪便疏松/腹泻(n=23/61,38%),尿培养阳性(n=19/61,31%),和非临床低血糖(BG<63mg/dL;n=8/61,13%);Caninsulin/s:临床和非临床低血糖(n=35/66,53%),尿培养阳性(n=18/66,27%),和松散的粪便/腹泻(n=10/66,15%)。糖尿病酮症酸中毒发生在4/61(7%;velagliflozin)和0/66(Caninsular)。
结论:每日口服维格列净不劣于胰岛素注射,表现出良好的QoL和血糖,无临床低血糖。
BACKGROUND: Options for treatment of diabetes mellitus in cats are limited to insulin injections and monitoring for hypoglycemia.
OBJECTIVE: Once daily sodium-glucose cotransporter-2 inhibitor velagliflozin PO is noninferior to insulin injections.
METHODS: Client-owned diabetic cats (127 safety; 116 efficacy assessment).
METHODS: Prospective, randomized (1 mg/kg velagliflozin), positive controlled (titrated Caninsulin), open label, noninferiority field trial, comparing number of cats with treatment success in ≥1 clinical variable and ≥1 glycemic variable (margin Δ: 15%) on Day 45; secondary endpoints included glycemic and clinical assessments during 91 days.
RESULTS: On Day 45, 29/54 (54%) velagliflozin-treated cats and 26/62 (42%) Caninsulin-treated cats showed treatment success, demonstrating noninferiority (difference -11.8%; upper 1-sided 97.5% confidence interval, -∞ to 6.3%). By Day 91, quality of life (QoL), polyuria, and polydipsia had improved in 81%, 54% and 61% (velagliflozin); on blood glucose (BG) curves, mean BG was <252 mg/dL in 42/54 (78%; velagliflozin) and 37/62 (60%; Caninsulin); minimum BG was <162 mg/dL in 41/54 (76%; velagliflozin) and 41/62 (66%; Caninsulin); serum fructosamine was <450 μmol/L in 41/54 (76%; velagliflozin) and 38/62 (61%; Caninsulin). Velagliflozin\'s most frequent adverse events were loose feces/diarrhea (n = 23/61, 38%), positive urine culture (n = 19/61, 31%), and nonclinical hypoglycemia (BG <63 mg/dL; n = 8/61, 13%); Caninsulin\'s: clinical and nonclinical hypoglycemia (n = 35/66, 53%), positive urine culture (n = 18/66, 27%), and loose feces/diarrhea (n = 10/66, 15%). Diabetic ketoacidosis occurred in 4/61 (7%; velagliflozin) and 0/66 (Caninsulin).
CONCLUSIONS: Once daily oral administration of velagliflozin was noninferior to insulin injections, showed good QoL and glycemia without clinical hypoglycemia.