Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1356 BS during 4 week treatment duration
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1356 BS, low dose | Experimental |
| |
| BI 1356 BS, medium dose | Experimental |
| |
| BI 1356 BS, high dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1356 BS, low dose | Drug |
| ||
| BI 1356 BS, medium dose |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of tolerability by investigator on a 4-point scale | Day 50 | |
| Incidence of adverse events | up to 50 days | |
| Number of patients with abnormal changes in clinical laboratory parameters | Baseline, up to day 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum concentration of the analyte in plasma) | before and up to 43 days after first study drug administration | |
| tmax (time from dosing to maximum concentration) | before and up to 43 days after first study drug administration |
Not provided
Inclusion Criteria:
Male and female postmenopausal patients with proven diagnose of type 2 diabetes mellitus treated with diet and exercise only or with one (or two) oral hypoglycaemic agents besides glitazones
Glycosylated haemoglobin A1 (HbA1c)
Male patients: Age ≥21 and Age ≤70 years
Female patients: Age ≥60 and Age ≤70 years
BMI ≥18.5 and BMI ≤35 kg/m2 (Body Mass Index)
Caucasian ethnicity
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Exclusion Criteria:
Male Patients:
Female patients:
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| BI 1356 BS, high dose | Drug |
|
| Placebo | Drug |
|
| AUC (area under the concentration-time curve of the analyte in plasma) for several time points | before and up to 43 days after first study drug administration |
| Cmax,ss (maximum concentration of the analyte in plasma at steady state over a uniform dosing interval) | before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration |
| Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval) | before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration |
| Cpre,N (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N) | pre-dose on day 28 |
| tmax,ss (time from dosing to maximum concentration at steady state) | before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration |
| AUCτ,ss (area under the concentration time curve of the analyte in plasma at steady state over a uniform dosing interval) | before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration |
| λz,ss (terminal rate constant in plasma at steady state) | before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration |
| t1/2,ss (terminal half-life of the analyte in plasma at steady state) | before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration |
| MRTpo,ss (mean residence time of the analyte in the body after 12 administrations at steady state) | before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration |
| CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state) | before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration |
| Vz/F,ss (apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state) | before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration |
| PTF (peak trough fluctuation) | before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration |
| Accumulation ratio (RA) based on Cmax | up to 28 days |
| RA,AUC based on AUCτ | up to 28 days |
| Dipeptidyl-Peptidase IV (DPP-IV) activity for several time points | up to day 43 |
| Change in fasting plasma glucose (AUEC0-3) after MTT (meal tolerance test ) | days -1, 1 and 29 |
| Plasma glucose levels | up to day 43 |
| D004700 | Endocrine System Diseases |
| D011799 | Quinazolines |