Velagliflozin, a once-daily, liquid, oral SGLT2 inhibitor, is effective as a stand-alone therapy for feline diabetes mellitus: the SENSATION study.

Abstract

OBJECTIVE: To investigate safety and effectiveness of velagliflozin oral solution as sole therapy in na&#xef;ve and previously insulin-treated diabetic cats. ANIMALS: 252 client-owned cats receiving &#x2265; 2 doses of velagliflozin; 214 (85%) na&#xef;ve diabetics and 38 (15%) insulin-treated diabetics. PROCEDURES: Prospective, baseline-controlled, open-label clinical field trial. Cats received velagliflozin orally, once daily. Physical examinations and blood collections were performed days 0, 3, 7, 30, 60, 120, and 180. RESULTS: Data are median (range). Screening blood glucose (BG) was 436 mg/dL (272 to 676 mg/dL). On days 30, 60, 120, and 180, single BG after receiving velagliflozin was 153 mg/dL (62 to 480 mg/dL), 134 mg/dL (64 to 414 mg/dL), 128 mg/dL (55 to 461 mg/dL), and 125 mg/dL (77 to 384 mg/dL), respectively. Screening fructosamine was 538 &#xb5;mol/L (375 to 794 &#xb5;mol/L). On the same recheck days, fructosamine was 310 &#xb5;mol/L (204 to 609 &#xb5;mol/L), 286 &#xb5;mol/L (175 to 531 &#xb5;mol/L), 269 &#xb5;mol/L (189 to 575 &#xb5;mol/L), and 263 &#xb5;mol/L (203 to 620 &#xb5;mol/L). At day 180, 81% of 158 cats remaining had BG and/or fructosamine within reference ranges; 88.6% (124 of 140) and 87.7% (121 of 138) showed improvement in polyuria and polydipsia, respectively. Ketonuria developed in 35 cats (13.9%), including 18 (7.1%) that had ketoacidosis. Ketoacidosis was less common in na&#xef;ve diabetic cats (11 of 214 [5.1%]) compared to insulin-treated diabetic cats (7 of 38 [18.4%]). At ketoacidosis diagnosis, 14 of 18 cats (77.8%) were euglycemic (ie, BG < 250 mg/dL). Most episodes of ketosis or ketoacidosis (30 of 35 [85.7%]) occurred within the first 14 days of treatment. Insulin-treated diabetic cats were less likely to complete the trial. No clinical hypoglycemia occurred. CLINICAL RELEVANCE: Velagliflozin improved glycemic parameters and clinical signs in diabetic cats. Velagliflozin provides an alternative to insulin as a stand-alone treatment of diabetic cats.