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Clinical Trial Details

Trial ID: L4026
Source ID: NCT02183350
Associated Drug: Bi 1356 Bs - Single Rising Dose
Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 1356 BS in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: BI 1356 BS - single rising dose|DRUG: Placebo
Outcome Measures: Primary: Number of patients with adverse events, up to 28 days|Number of patients with abnormal findings in physical examination, up to 28 days|Number of patients with abnormal changes in Vital signs (blood pressure (BP), pulse rate (PR)), up to 28 days|Number of patients with abnormal changes in 12-lead ECG (electrocardiogram), up to 28 days|Number of patients with abnormal changes in laboratory parameters, up to 28 days|Assessment of tolerability by investigator on a 4-point scale, up to 28 days | Secondary: Cmax (maximum concentration of the analyte in plasma), predose, up to 456 h|tmax (time from dosing to maximum concentration), predose, up to 456 h|AUC (area under the concentration-time curve of the analyte in plasma), predose, up to 456 h|Ae (amount of analyte that is eliminated in urine), predose, up to 456 h|fe (fraction of analyte excreted in urine), up to 288 h|CLR (renal clearance of the analyte in plasma), up to 288 h|Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval), predose, up to 456 h|Cpre,N (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N), predose, up to 456 h|λz,ss (terminal rate constant in plasma at steady state), predose, up to 456 h|t1/2,ss (terminal half-life of the analyte in plasma at steady state), predose, up to 456 h|MRTpo,ss (mean residence time of the analyte in the body after 12 administrations at steady state), predose, up to 456 h|CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state), predose, up to 456 h|Vz/F,ss (apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state), predose, up to 456 h|Changes in PTF (peak trough fluctuation), up to 28 days|RA,Cmax based on Cmax, predose, up to 456 h|RA,AUC based on AUCτ, predose, up to 456 h|Changes in Dipeptidyl-Peptidase IV (DPP-IV) activity in plasma, predose, up to 456 h|Change in plasma glucose levels, up to 13 days
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: MALE
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 47
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2005-04
Completion Date:
Results First Posted:
Last Update Posted: 2014-07-08
Locations:
URL: https://clinicaltrials.gov/show/NCT02183350