Efficacy and safety of once daily oral administration of sodium-glucose cotransporter-2 inhibitor velagliflozin compared with twice daily insulin injection in diabetic cats

Niessen, SJM; Kooistra, HS; Forcada, Y; Bjornvad, CR; Albrecht, B; Roessner, F; Herberich, E; Kroh, C

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 Delta: 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, -infinity 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 mu mol/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.

Citation

Niessen, S., Kooistra, H., Forcada, Y., Bjornvad, C., Albrecht, B., Roessner, F., …Kroh, C. (2024). Efficacy and safety of once daily oral administration of sodium-glucose cotransporter-2 inhibitor velagliflozin compared with twice daily insulin injection in diabetic cats. Journal of Veterinary Internal Medicine, https://doi.org/10.1111/jvim.17124

• Journal Article Type: Article
• Acceptance Date: May 14, 2024
• Online Publication Date: Jun 17, 2024
• Publication Date: 2024
• Deposit Date: Jul 26, 2024
• Publicly Available Date: Jul 26, 2024
• Print ISSN: 0891-6640
• Publisher: Wiley Open Access
• Peer Reviewed: Peer Reviewed
• DOI: https://doi.org/10.1111/jvim.17124
• Keywords: antidiabetic; beta-cell; compliance; feline diabetes mellitus; glucosuria; glucotoxicity; glycemic control; prospective clinical trial; sodium-glucose cotransporter-2 (SGLT2) inhibitor; URINARY-TRACT-INFECTION; PORCINE LENTE INSULIN; SGLT2 INHIBITORS; RIS