300 M 51.7 11 F 135 28 1000 M 211 45 F 296 62 26 trial 30 M 11.2 2 Rat (Wistar) F 26.0 5 100 M 47.4 10 F 87.8 19 700 M 166 35 F 372 78 2 years 100 M 79.8 17 (carcinogenicity) F 100 21 300 M 122 26 F 214 45 700 M 197 42 F 340 72 Dog 52 weeks 10 M/F 85.9 18 (Beagle) 30 M/F 250 53 100 M/F 1140 241 Human 28 days (25 mg) M+F 4.74 – (Type 2 steady state diabetes (Study number patients) U09-1970) #M = male, F = female. ##Animal:human plasma AUC0-24 h. Major toxicities In general, the toxicity profile of empagliflozin was similar to others in the pharmacological class with effects associated with the primary pharmacology of the drug (glucosuria, osmotic diuresis, effects on body weight and food consumption), secondary effects associated with SGLT2 inhibition (changes in the liver, pancreas and adrenals, other clinical chemistry changes and the risk of urinary tract infections (UTIs)) or target effects on SGLT1 (gastrointestinal toxicity, effects on bone production and vascular mineralisation). Additional findings not seen with others in the pharmacological class, included additional effects on the kidneys of male mice.
300 M 51.7 11 F 135 28 1000 M 211 45 F 296 62 Rat (Wistar) 26 30 M 11.2 2 F 26.0 5 100 M 47.4 10 F 87.8 19 700 M 166 35 F 372 78 2 years (carcinogenicity) 100 M 79.8 17 F 100 21 300 M 122 26 F 214 45 700 M 197 42 F 340 72 Dog (Beagle) 52 weeks 10 M/F 85.9 18 30 M/F 250 53 100 M/F 1140 241 Human (Type 2 diabetes patients) 28 days steady state (Study number U09-1970) (25 mg) M+F 4.74 – #M = male, F = female. ##Animal:human plasma AUC0-24 h. Major toxicities In general, the toxicity profile of empagliflozin was similar to others in the pharmacological class with effects associated with the primary pharmacology of the drug (glucosuria, osmotic diuresis, effects on body weight and food consumption), secondary effects associated with SGLT2 inhibition (changes in the liver, pancreas and adrenals, other clinical chemistry changes and the risk of urinary tract infections (UTIs)) or effects on SGLT1 (gastrointestinal toxicity, effects on bone production and vascular mineralisation). Additional findings not seen with others in the pharmacological class, included additional effects on the kidneys of male mice. trial target