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Clinical Trial Details

Trial ID: L2271
Source ID: NCT02212925
Associated Drug: Bi 14332 Cl
Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 14332 CL as Tablet in Female and Male Patients With Type 2 Diabetes
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: BI 14332 CL|DRUG: Placebo
Outcome Measures: Primary: Number of patients with adverse events, up to 14 days after last drug administration|Number of patients with clinically significant findings in vital signs (blood pressure, pulse rate), up to 14 days after last drug administration|Number of patients with clinically significant findings in ECG, up to 14 days after last drug administration|Number of patients with clinically significant findings in laboratory tests, up to 14 days after last drug administration|Assessment of tolerability by investigator on a 4-point scale, up to 14 days after last drug administration | Secondary: Cmax (maximum concentration of the analyte in plasma), up to 18 days after first drug administration|tmax (time from dosing to maximum concentration), up to 18 days after first drug administration|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), up to 18 days after first drug administration|AUCτ,1 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h after administration of the first dose), up to 18 days after first drug administration|Ae0-24 (amount of analyte that is eliminated in urine from the time interval 0 h to 24 h), up to 11 days after first drug administration|fe0-24 (fraction of analyte excreted in urine from time point 0 h to 24 h), up to 11 days after first drug administration|CLR,0-24 (renal clearance of the analyte in plasma from the time point 0 h until the time point 24 h), up to 11 days after first drug administration|Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval), up to 18 days after first drug administration|Cpre,N (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N), up to 18 days after first drug administration|PTF (peak trough fluctuation), in percent, up to 18 days after first drug administration|RA,Cmax (accumulation ratio based on Cmax), up to 18 days after first drug administration|RA,AUC(accumulation ratio based on AUCτ), up to 18 days after first drug administration|Change in dipeptidyl-peptidase 4 (DPP-IV) activity, baseline, up to 18 days after first drug administration|Area under the curve of plasma glucose, baseline, up to 3 hours after intake of standardized meal
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 38
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2006-11
Completion Date:
Results First Posted:
Last Update Posted: 2014-08-08
Locations:
URL: https://clinicaltrials.gov/show/NCT02212925