TABLE 2.
Comparison of primary, secondary, and exploratory endpoints between placebo and canagliflozin treated insulin dysregulated horses.
| Parameter | Placebo (n = 8) | Canagliflozin (n = 8) | Least square mean difference canagliflozin vs placebo | Geometric least square mean ratio canagliflozin/placebo (%) | P‐value |
|---|---|---|---|---|---|
| Primary endpoint | |||||
| Insulin AUC0‐180 (μIU/mL × min) | 24 832 (17 817‐34 610) | 8308 (5961‐11 579) | n/a | 33.5 (20.9‐53.6) | <.001 |
| Insulin C max (μIU/mL) | 215.2 (143.2‐323.2) | 83.2 (55.4‐125.0) | n/a | 38.7 (21.7‐69.0) | .004 |
| Secondary endpoint | |||||
| Fasting insulin (μIU/mL) | n/a | ||||
| Covariate at 10.7 (μIU/mL) | 9.0 ± 1.8 | 13.1 ± 2.7 | 4.1 (−3.1 to 11.2) | .8 | |
| Covariate at 25.4 (μIU/mL) | 22.1 ± 1.7 | 13.1 ± 1.6 | −9.0 (−14.2 to −3.9) | .02 | |
| Covariate at 40.1 (μIU/mL) | 35.2 ± 3.1 | 13.1 ± 1.7 | −22.1 (−29.8 to −14.3) | <.001 | |
| Fasting plasma glucose (mmol/L) | 4.9 ± 0.1 | 4.7 ± 0.1 | −0.2 (−0.5 to 0.04) | n/a | .09 |
| Glucose C max (mmol/L) | 8.4 ± 0.3 | 7.0 ± 0.3 | −1.4 (−2.5 to −0.4) | n/a | .01 |
| Glucose AUC0‐180 (mmol/L × min) | 1281 (1190‐1380) | 1094 (1016‐1178) | n/a | 85.4 (76.6‐95.2) | .01 |
| Body weight (kg) | 319 ± 2.2 | 308 ± 2.2 | −11.1 (−18.1 to −4.0) | .01 | |
| Triglycerides (mmol/L) | 0.48 ± 0.17 | 1.47 ± 0.17 | 0.99 (0.47 to 1.50) | .001 | |
| Exploratory endpoint | |||||
| ∆AUCinsulin/∆AUCglucose (mIU/mmol) | 58.1 (43.2‐78.1) | 25.1 (18.7‐33.8) | n/a | 43.2 (28.3‐66.1) | <.001 |
Note: Adjusted means for baseline values are presented as least square mean ± SE of the mean or geometric least square means with 95% confidence interval. Least square mean difference or geometric least square mean ratio for canagliflozin vs placebo are reported with 95% confidence intervals.
Abbreviations: ∆AUCinsulin/∆AUCglucose, ratio of incremental area under the curve for insulin and incremental area under the curve for glucose; glucose AUC0‐180, area under the glucose vs time curve at 0‐180 min; Glucose C max, maximal glucose concentration; insulin AUC0‐180, area under the plasma insulin vs time curve at 0 to 180 minutes; insulin C max, maximal insulin concentration; n/a, not applicable.