| Outcome Measures: |
Primary: Change From Baseline in Urine Glucose Excretion, Change from baseline in Urine glucose excretion to 28 days, baseline and 28 days|Change From Baseline in Fasting Plasma Glucose, Change from baseline in Fasting plasma glucose to 28 days, baseline and 28 days|Change From Baseline in 8-point Glucose, Change from baseline in 8-point glucose to 27 days, baseline and 27 days | Secondary: Change From Baseline in HbA1c, Change from baseline in HbA1c to 28 days, baseline and 28 days|Change From Baseline in Fructosamine, Change from baseline in Fructosamine to 28 days, baseline and 28 days|Change From Baseline in 1,5-anhydroglucitol, Change from baseline in 1,5-anhydroglucitol to 28 days, baseline and 28 days|Change From Baseline in Fasting Insulin, Change from baseline in Fasting insulin to 28 days, baseline and 28 days|Change From Baseline in the Area Under the Curve of Plasma Glucose Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test), Change from baseline in the area under the curve of plasma glucose levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days, baseline and 28 days|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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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
|
