Efficacy and safety of once daily oral administration of sodium-glucose cotransporter-2 inhibitor velagliflozin compared with twice daily insulin injection in diabetic cats.
J Vet Intern Med. 2024 Jul-Aug;38(4):2099 - 2119.
Stijn J M Niessen1, Hans S Kooistra2, Yaiza Forcada3, Charlotte R Bjørnvad4, Balazs Albrecht5, Franziska Roessner6, Esther Herberich7, Carla Kroh8 1 Veterinary Specialist Consultations & VIN Europe, Hilversum, The Netherlands.; 2 Department of Clinical Sciences, Faculty of Veterinary Medicine, Utrecht University, Utrecht, The Netherlands.; 3 Veterinary Specialist Consultations & VIN Europe, Hilversum, The Netherlands.; 4 Bjørnvad Consultancy, Vedbæk, Denmark.; 5 Boehringer Ingelheim Vetmedica GmbH, Ingelheim am Rhein, Germany.; 6 Boehringer Ingelheim Vetmedica GmbH, Ingelheim am Rhein, Germany.; 7 Boehringer Ingelheim Vetmedica GmbH, Ingelheim am Rhein, Germany.; 8 Boehringer Ingelheim Vetmedica GmbH, Ingelheim am Rhein, Germany.
© 2024 The Author(s). Journal of Veterinary Internal Medicine published by Wiley Periodicals LLC on behalf of American College of Veterinary Internal Medicine.
Abstract
BACKGROUND:Options for treatment of diabetes mellitus in cats are limited to insulin injections and monitoring for hypoglycemia.
HYPOTHESIS:Once daily sodium-glucose cotransporter-2 inhibitor velagliflozin PO is noninferior to insulin injections.
ANIMALS: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 AND CLINICAL IMPORTANCE:Once daily oral administration of velagliflozin was noninferior to insulin injections, showed good QoL and glycemia without clinical hypoglycemia.
Keywords

antidiabetic;
beta‐cell;
compliance;
feline diabetes mellitus;
glucosuria;
glucotoxicity;
glycemic control;
prospective clinical trial;
sodium‐glucose cotransporter‐2 (SGLT2) inhibitor;
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