Treatment of diabetes mellitus (DM) in dogs typically requires q 12 h to q 24 h insulin injections, posing a major compliance issue for pet owners. Novel treatments enabling decreased frequency of injection while maintaining safety are highly desirable. In this pilot study, we assessed an ultra-long-acting novel formulation of recombinant fusion protein of canine insulin and canine Fc (AKS-218d) administered subcutaneously. Four dogs with spontaneous DM, controlled on stable doses of standard q12h insulin, were transitioned to AKS-218d. The dose of AKS-218d was titrated for 8 weeks based on continuous flash glucose monitoring (FGM). Clinical signs, body weight, fructosamine and mean interstitial glucose (IG) concentrations were compared between baseline (week zero, on standard insulin therapy) and week 8. Data were assessed for normality and compared using parametric or non-parametric (as appropriate) paired tests. After 8 weeks of once-weekly injection, compared to baseline, there were no changes in clinical signs and body weight (mean [±SD] body weight change=0.05±0.96 kg, p=0.9). There were no changes in fructosamine (−34±145 mmol/L, p=0.9) and mean IG concentrations (−0.7±10.0 mmol/L, p=0.9). Low IG (<3.9 mmol/L) was recorded in 2 dogs at week zero (1% and 23% of readings) and 2 dogs at week 9 (5% and 6% of readings). There were no adverse reactions to AKS-218d. In conclusion, successful maintenance of glycemia was achieved with this once-weekly novel insulin therapy. The efficacy and safety of this novel formulation should be further assessed in a large clinical trial.

Disclosures

Disclosures to report.
This work was funded by Akston Biosciences.