4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM)

Change From Baseline in the Area Under the Curve of Glucagon Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)

Change from baseline in the area under the curve of glucagon levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days

Time frame: baseline and 28 days

Change From Baseline in the Area Under the Curve of Insulin Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)

Change from baseline in the area under the curve of insulin levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days

Time frame: baseline and 28 days

AUCτ,1

Area under the concentration-time curve of the analyte in plasma after administration of the first dose over a uniform dosing interval τ

Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration

AUC0-tz

area under the concentration-time curve of the analyte in plasma over the time interval from 0 to last quantifiable plasma concentration

Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration

AUC0-∞

area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity

Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration

Cmax

maximum measured concentration of the analyte in plasma

Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration

t1/2

terminal half-life of the analyte in plasma

Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration

CL/F

apparent clearance of the analyte in plasma after extravascular administration

Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration

Vz/F

apparent volume of distribution during the terminal phase λz following an extravascular dose

Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration

Ae0-24

amount of the analyte that is eliminated in urine over the time interval 0 to 24

Time frame: 0-5, 5-12, 12-24 hour after first drug administration

fe0-24

fraction of the analyte excreted unchanged in urine from time interval 0 to 24

Time frame: 0-5, 5-12, 12-24 hour after first drug administration

CLR,0-24

renal clearance of the analyte in plasma after extravascular administration - based on 0-24 hours data

Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min, 0-5h, 5-12h, 12-24h after first drug administration

AUCτ,ss

area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ at steady state

Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration

Cmax,ss

maximum measured concentration of the analyte in plasma at steady state

Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration

t1/2,ss

terminal half-life of the analyte in plasma at steady state

Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration

CL/F,ss

apparent clearance of the analyte in plasma after extravascular administration at steady state

Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration

Vz/F,ss

apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state

Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration

RA,Cmax

accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on Cmax

Time frame: Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration

RA,AUC

accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on AUCτ

Time frame: Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration

Ae0-24,ss

amount of the analyte that is eliminated in urine at steady state over the time interval 0 to 24

Time frame: 0-5, 5-12, 12-24 hour after last drug administration

fe0-24,ss

fraction of the analyte excreted unchanged in urine at steady state from time interval 0 to 24

Time frame: 0-5, 5-12, 12-24 hour after last drug administration

CLR,ss

renal clearance of the analyte at steady state determined over the dosing interval τ

Time frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 0-5h, 5-12h, 12-24h after last drug administration