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Clinical Trial Details

Trial ID: L5968
Source ID: NCT02211963
Associated Drug: Bi 44847
Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 44847 in Female and Male Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: BI 44847|DRUG: Placebo
Outcome Measures: Primary: Number of patients with adverse events, up to 53 days|Number of patients with clinically significant findings in vital signs (blood pressure (BP), pulse rate (PR)), up to 18 days|Number of patients with clinically relevant findings in 12-lead electrocardiogram (ECG), up to 18 days|Number of patients with clinically relevant laboratory findings, up to 18 days|Assessment of tolerability by investigator on a 4-point scale, Day 18 | Secondary: Maximum concentration of the analyte in plasma for several time points (Cmax), up to 72 hours after drug administration|Time from dosing to maximum concentration for several time points (tmax), up to 72 hours after drug administration|Terminal half-life of the analyte in plasma for several time points (t1/2), up to 72 hours after drug administration|Terminal rate constant in plasma for several time points (λz), up to 72 hours after drug administration|Concentration of analyte in plasma for several time points, 12 and 24 hours after drug administration on day 1 and 9|Area under the concentration-time curve of the analyte in plasma for several time points (AUC), up to 72 hours after drug administration|Amount of analyte that is eliminated in urine for several time points (Ae), up to 72 hours after drug administration|Fraction of analyte excreted unchanged in urine for several time points (fe), up to 72 hours after drug administration|Renal clearance of the analyte in plasma for several time points (CLR), up to 72 hours after drug administration|Apparent clearance of the analyte in the plasma for several time points (CL/F), up to 72 hours after drug administration|Apparent volume of distribution during the terminal phase λz following an extravascular dose for several time points (Vz/F), up to 72 hours after drug administration|Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval), up to 72 hours after drug administration|tmin,ss (time from dosing to minimum concentration during a dosing interval), up to 72 hours after drug administration|Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose for several time points, up to day 9|MRTpo,ss (mean residence time of the analyte in the body after 11 administrations (b.i.d.) and 6 administrations (q.d.) respectively, at steady state), up to 72 hours after drug administration|Cavg (average concentration), up to 72 hours after drug administration|PTF (peak trough fluctuation), up to 72 hours after drug administration|Accumulation ratio (RA) based on Cmax, up to 72 hours after drug administration|Accumulation ratio (RA) based on AUC, up to 72 hours after drug administration|Plasma glucose levels, up to 15 hours after drug administration|Amount of glucose excreted in urine, up to 72 hours after drug administration
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 48
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2007-02
Completion Date:
Results First Posted:
Last Update Posted: 2014-08-13
Locations:
URL: https://clinicaltrials.gov/show/NCT02211963