The objective of this study is to assess the effect of the different degrees of renal impairment on the pharmacokinetics, pharmacodynamics and safety of BI10773 following oral administration of high dose BI10773 as a single dose in Japanese patients with type 2 diabetes mellitus.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
1245.53.001 Boehringer Ingelheim Investigational Site
Kurume, Fukuoka, Japan
Change From Baseline in Total Urinary Glucose Excretion (UGE)
change from baseline in total urinary glucose excretion (UGE) to 24 hours
Time frame: baseline and 24 hours
Area Under the Concentration Time Curve of the Analyte in Plasma
Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity
Time frame: Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration
Maximum Concentration
Maximum concentration of the analyte in plasma
Time frame: Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
BI10773 medium dose tablet single dose