| Outcome Measures: |
Primary: Weight and waist circumference - change from baseline, Day 28 (Hour = 647:30)|Frequency of patients with maximal increase from baseline QTcF and QTcB interval, 4 weeks|Frequency of patients with possible clinically significant abnormalities, 4 weeks|Micturition total frequency - change from baseline, Day 28|Global tolerability - number of patients by category, 4 weeks | Secondary: Cmax (maximum concentration of the analyte in plasma), Day 1|Tmax (time from dosing to maximum concentration), Day 1|t1/2 (terminal half-life of the analyte in plasma), Day 1|λz (terminal rate constant in plasma), Day 1|C12,1 (concentration of analyte in plasma at 12 hours post-drug administration after administration of the first dose), Day 1|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point within the first dosing interval), Day 1|AUC0-12 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 h after administration of the first dose), Day 1|Ae0-12 (amount of analyte that is eliminated in urine over the time interval 0 h to 12 h), Day 1|fe0-12 (fraction of analyte excreted unchanged in urine from time points 0 h to 12 h), Day 1|CLR (renal clearance of the analyte in plasma after extravascular administration - based on 0 - 12 hour data), Day 1|CL/F (apparent clearance of the analyte in the plasma after extravascular administration), Day 1|Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose), Day 1|Cmax,ss (maximum concentration of the analyte in plasma at steady state over a uniform dosing interval), Day 28|Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval), Day 28|Cpre,N (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N), Day 28|Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the last dose), Day 28|C12,ss (concentration of analyte in plasma at 12 hours post-drug administration at steady state), Day 28|tmax,ss (time from dosing to maximum concentration at steady state), Day 28|tmin,ss (time from dosing to minimum concentration during a dosing interval), Day 28|AUC0-tz,ss (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point within the last dosing interval), Day 28|AUC0-12,ss (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 h at steady-state), Day 28|MRTpo,ss (mean residence time of the analyte in the body after 56 administrations (b.i.d.) at steady state), Day 28|CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state), Day 28|Vz/F,ss (apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state), Day 28|Ae0-12,ss (amount of analyte that is eliminated in urine at steady state over the time interval 0 to 12 h), Day 28|fe0-12,ss (fraction of analyte excreted unchanged in urine at steady state over the time interval 0 to 12 h), Day 28|CLR,ss (renal clearance of the analyte at steady state - based on 0 - 12 hour data), Day 28|RA,Cmax based on Cmax, following 55 doses (bid)|RA,AUC based on AUCτ, following 55 doses (bid)|Predose concentrations of the analyte in plasma, 5 minutes before drug administration on days 2,3,4,7,14,21,26,27,28 and 29|Change from baseline in UGE, AE0-24, Day 27|Change from baseline in weighted MDG, AUEC0-24, Day 27|Epre-corrected AUEC0-5 following OGTT, Day 28|Cavg (average concentration), day 28|PTF (peak trough fluctuation)., day 28
|
