Efficacy and safety of canagliflozin in insulin dysregulated horses: a 4-week multi-arm, double-blind, randomized, clinical trial.

Canagliflozin reduces hyperinsulinemia in insulin-dysregulated horses but causes dose-dependent hypertriglyceridemia requiring monitoring.

This multicenter, randomized, double-blind, placebo-controlled clinical trial evaluated the efficacy and safety of the SGLT2 inhibitor canagliflozin in 42 privately owned horses with severe insulin dysregulation (ID). Horses were allocated equally to receive canagliflozin at 0.6 mg/kg, 1.2 mg/kg, or placebo orally once daily for 4 weeks. Insulin and glucose responses were assessed during an oral sugar test (OST) and a forage-based feed challenge test (FCT) at baseline and following the treatment period. Both canagliflozin doses significantly reduced peak insulin concentrations compared to placebo during both the OST and FCT (P ≤ .01). During the OST, peak insulin was reduced to 122.0 and 108.6 µIU/mL for the 0.6 and 1.2 mg/kg groups, respectively, versus 288.7 µIU/mL for placebo. Similar reductions were observed during the FCT. However, canagliflozin induced a clinically relevant, dose-dependent increase in serum triglyceride concentrations, rising from 0.5 mmol/L in the placebo group to 1.3 and 2.9 mmol/L in the 0.6 and 1.2 mg/kg groups, respectively. Elevated triglycerides are a potential concern in horses, given the risk of hyperlipemia, particularly in animals under physiologic stress. These findings suggest canagliflozin is effective at reducing hyperinsulinemia in ID horses but warrants careful monitoring of lipid metabolism, especially at higher doses. Clinicians should weigh the benefits of insulin reduction against the risk of hypertriglyceridemia when considering long-term or high-dose SGLT2 inhibitor therapy in equine patients.

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