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Clinical Trial Details

Trial ID: L6586
Source ID: NCT00558571
Associated Drug: Bi 10773 Low Dose
Title: 4 Week Treatment With Three Oral Doses of BI 10773 in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00558571/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: BI 10773 low dose|DRUG: placebo to BI 10773|DRUG: BI 10773 medium dose|DRUG: BI 10773 high dose
Outcome Measures: Primary: Number of Subjects With Drug Related Adverse Events, number of subjects with investigator-defined drug-related adverse events., from drug administration up to 6 weeks|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG, Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events., from drug administration up to 6 weeks | Secondary: Cmax of Empagliflozin, maximum concentration of the analyte in plasma after first dose (Cmax, Day 1 ) and at steady state over a uniform dosing interval (Cmax,ss, Day 28)., 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 hours(h) after drug administration on day 1 and 28|Tmax of Empagliflozin, time from last dosing to maximum concentration of the analyte in plasma after first dose (Day 1), denoted by tmax; and at steady state (Day 28), denoted by tmax,ss., 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28|t1/2 of Empagliflozin, terminal half-life of the analyte in plasma after first dose (Day 1), denoted by t1/2; and at steady state (Day 28), denoted by t1/2,ss., 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28|AUC0-∞ of Empagliflozin, Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) and over a uniform dosing interval τ at steady state (AUCτ,ss), 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1|CL/F of Empaglifozin, apparent clearance of the analyte in plasma after first dose (CL/F) and at steady state (CL/F,ss), 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28|fe0-24 of Empagliflozin, Fraction of analyte eliminated in urine from time point 0 to 24h after first dose (fe0-24) and at steady state (fe0-24,ss), 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28|LI (Linearity Index)., The linearity index is defined as AUC0-τ divided by AUC0-∞ both at steady state., 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 after drug administration on day 1 and 28|Ae0-24 of Glucose, Amount of glucose eliminated in urine over the time interval 0 to 24h on day -2, -1, 1, 27 and 28. (Urinary Glucose Excretion), Day -2 and 27: -2 to 0, 0 to 5, 5 to 12 and 12 to 24h; Day -1 and 1: 0 to 5, 5 to 12 and 12 to 24; Day 28: 0 to 5, 5 to 12, 12 to 24, 24 to 36, 36 to 48 and 48 to 72h|Fasting Plasma Glucose (FPG), fasting plasma glucose on day -1 (baseline) and change from baseline to day 28, in the morning of days -1 and 28|Mean Daily Glucose (MDG) Measured in Blood, change from baseline in MDG on the days 1, 7, 14, 21 and 27. Baseline is defined as day -2., 0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day -2. 0:05 h before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day 1, 7, 14, 21 and 27|Insulin AUEC0-5, change in AUEC0-5 from baseline on day 28. Baseline is defined as day -1., 0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.|Insulin Emax (Maximum Measured Effect), change in Emax from baseline on day 28. Baseline is defined as day -1, 0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.|Fasting Insulin, Change from baseline to the days 1, 7, 14, 21 and 28. Baseline is defined as day -1., in the morning of days -1( baseline), 1, 7, 14, 21 and 28|Glucagon Emax (Maximum Measured Effect), Change from baseline (day -1) in Emax on day 28., 0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 24:00 h after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.|Glucagon AUEC0-5, Change from baseline (day -1) in AUEC0-5 on day 28., 0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.|Fructosamine, change from baseline to days 14 and 18. Baseline is defined as day -1., day -1 (baseline), 14 and 28|HbA1c, change from baseline on day 28. Baseline is defined as day -1., in the morning of days -1 and 28
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 78
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2008-01
Completion Date:
Results First Posted: 2014-08-07
Last Update Posted: 2014-08-07
Locations: 1245.4.49003 Boehringer Ingelheim Investigational Site, Berlin, Germany|1245.4.49002 Boehringer Ingelheim Investigational Site, Mainz, Germany|1245.4.49001 Boehringer Ingelheim Investigational Site, Neuss, Germany
URL: https://clinicaltrials.gov/show/NCT00558571