| Outcome Measures: |
Primary: AUC0-inf, Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)., Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|AUC0-tz, Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)., Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Cmax, Maximum measured concentration in plasma (Cmax)., Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Tmax, Maximum measured concentration in plasma (tmax)., Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|t1/2, Terminal half-life in plasma (t1/2)., Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration. | Secondary: Change From Baseline in Urinary Glucose Excretion (UGE) Over 24 h After Study Drug Intake, Change from baseline in Urinary Glucose Excretion (UGE) over 24 h after study drug intake. For the changes from baseline in UGE on Day 1 (0 to 24 h postdose) , adjusted means per treatment group were to be calculated based on an ANCOVA including 'treatment' as a fixed effect and 'UGE at baseline' and 'FPG at baseline' as continuous covariates. Means presented are the adjusted means., baseline and 24 hours|Change From Baseline in Fasting Plasma Glucose (FPG) at 24 h After Study Drug Intake, Change from baseline in Fasting Plasma Glucose (FPG) at 24h after study drug intake. For the change from baseline in FPG at 24 h postdose (in the morning of Day 2), adjusted means per treatment group were to be calculated based on an ANCOVA including 'treatment' as a fixed effect and 'FPG at baseline' as continuous covariate. Means presented are the adjusted means., baseline and 24 hours|Change From Baseline in 8-point Plasma Glucose Profile Over 24 h After Study Drug Intake, Change from baseline in 8-point plasma glucose profile over 24h after study drug intake (as defined by change from baseline in Mean Daily Glucose (MDG) calculated at Day 1). For the changes from baseline in MDG on Day 1, adjusted means per treatment group were to be calculated based on an ANCOVA including 'treatment' as fixed effect and 'MDG at baseline' as continuous covariate. Means presented are the adjusted means., baseline and 24 hours
|
| Locations: |
1245.87.01013 Boehringer Ingelheim Investigational Site, New Haven, Connecticut, United States|1245.87.01004 Boehringer Ingelheim Investigational Site, Boston, Massachusetts, United States|1245.87.01002 Boehringer Ingelheim Investigational Site, Toledo, Ohio, United States|1245.87.01012 Boehringer Ingelheim Investigational Site, Philadelphia, Pennsylvania, United States|1245.87.01001 Boehringer Ingelheim Investigational Site, Pittsburgh, Pennsylvania, United States|1245.87.33001 Boehringer Ingelheim Investigational Site, Lyon, France|1245.87.97202 Boehringer Ingelheim Investigational Site, Beer Sheva, Israel|1245.87.97203 Boehringer Ingelheim Investigational Site, Tel Hashomer, Israel|1245.87.52001 Boehringer Ingelheim Investigational Site, Chihuahua, Mexico|1245.87.27003 Boehringer Ingelheim Investigational Site, Bellville, South Africa|1245.87.27002 Boehringer Ingelheim Investigational Site, Pretoria, South Africa
|
