To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 14332 CL following administration of multiple rising oral doses over 10 days in patients with type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
Number of patients with adverse events
Time frame: up to 14 days after last drug administration
Number of patients with clinically significant findings in vital signs (blood pressure, pulse rate)
Time frame: up to 14 days after last drug administration
Number of patients with clinically significant findings in ECG
Time frame: up to 14 days after last drug administration
Number of patients with clinically significant findings in laboratory tests
Time frame: up to 14 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: up to 14 days after last drug administration
Cmax (maximum concentration of the analyte in plasma)
Time frame: up to 18 days after first drug administration
tmax (time from dosing to maximum concentration)
Time frame: 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)
Time frame: 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)
Time frame: up to 18 days after first drug administration
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Ae0-24 (amount of analyte that is eliminated in urine from the time interval 0 h to 24 h)
Time frame: up to 11 days after first drug administration
fe0-24 (fraction of analyte excreted in urine from time point 0 h to 24 h)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: up to 18 days after first drug administration
PTF (peak trough fluctuation)
in percent
Time frame: up to 18 days after first drug administration
RA,Cmax (accumulation ratio based on Cmax)
Time frame: up to 18 days after first drug administration
RA,AUC(accumulation ratio based on AUCτ)
Time frame: up to 18 days after first drug administration
Change in dipeptidyl-peptidase 4 (DPP-IV) activity
Time frame: baseline, up to 18 days after first drug administration
Area under the curve of plasma glucose
Time frame: baseline, up to 3 hours after intake of standardized meal