# Differential glycemic effects of DWP16001 in diabetic dogs according to baseline glycemic status: a multicenter randomized controlled trial

## TL;DR

This study shows that DWP16001, a drug that lowers blood sugar, is safe and effective when used with insulin in diabetic dogs, especially those with poor initial blood sugar control.

## Contribution

The study provides the first clinical evidence of DWP16001's efficacy and safety in diabetic dogs as an insulin adjunct.

## Key findings

- DWP16001 significantly reduced fructosamine and HbA1c in dogs with poor baseline glycemic control.
- Treatment showed a trend toward reduced insulin requirements without significant weight loss or blood pressure changes.
- Asymptomatic hypoglycemia occurred in four dogs but resolved with insulin dose adjustments.

## Abstract

Sodium-glucose cotransporter 2 inhibitors are widely used in human medicine for their insulin-independent glucose-lowering effects. However, their clinical efficacy and safety for managing diabetes mellitus in dogs have not been established. This study aimed to evaluate the efficacy and safety of DWP16001, a selective sodium-glucose cotransporter 2 inhibitor, as an adjunct to insulin therapy for client-owned dogs with diabetes mellitus.

This multicenter, randomized, double-blind, placebo-controlled clinical trial involved 61 dogs receiving stable insulin therapy. They were randomly assigned to receive DWP16001 (0.025 mg/kg PO q24h) or placebo for 8 weeks. The changes in the serum fructosamine (weeks 0, 1, 4, and 8) and HbA1c (weeks 0, 4 and 8) concentrations and daily insulin dose were assessed. Safety evaluations included adverse event monitoring, physical examination, body weight measurement, blood gas and ketone analyses, urinalysis, and hematologic and biochemical profiling. Hypoglycemia was detected via blood glucose curve.

DWP16001 significantly reduced fructosamine and HbA1c concentrations in the dogs, especially in those with poor baseline glycemic control (fructosamine ≥ 500 µmol/L, HbA1c ≥ 6%). A trend toward reduced insulin requirements was observed in the treatment group without significant weight loss or clinically relevant changes in systolic blood pressure or signs of volume depletion. Asymptomatic hypoglycemia was detected in four dogs receiving DWP16001, but it resolved following insulin dose adjustment. No episodes of diabetic ketoacidosis were recorded, and laboratory parameters remained stable throughout the study.

DWP16001 is a safe and effective adjunct to insulin therapy for diabetic dogs, especially those with suboptimal glycemic control. It demonstrated insulin-sparing effects and favorable metabolic safety, necessitating further evaluation in long-term clinical studies.