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The primary objective of the current study is to investigate the safety and tolerability of BI 44847 in male and female patients with type 2 diabetes following oral administration of repeated doses of 100 mg b.i.d, 400 mg b.i.d. and 800 mg b.i.d. over 28 days.
A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI 44847 after multiple dosing, including assessment of steady state.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 44847 | Drug | |||
| placebo for BI 44847 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Weight and waist circumference - change from baseline | Day 28 (Hour = 647:30) | |
| Frequency of patients with maximal increase from baseline QTcF and QTcB interval | 4 weeks | |
| Frequency of patients with possible clinically significant abnormalities | 4 weeks | |
| Micturition total frequency - change from baseline | Day 28 | |
| Global tolerability - number of patients by category | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum concentration of the analyte in plasma) | Day 1 | |
| Tmax (time from dosing to maximum concentration) | Day 1 | |
| t1/2 (terminal half-life of the analyte in plasma) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1224.4.49002 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||||
| 1224.4.49003 Boehringer Ingelheim Investigational Site |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Day 1 |
| λz (terminal rate constant in plasma) | Day 1 |
| C12,1 (concentration of analyte in plasma at 12 hours post-drug administration after administration of the first dose) | Day 1 |
| 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) | Day 1 |
| AUC0-12 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 h after administration of the first dose) | Day 1 |
| Ae0-12 (amount of analyte that is eliminated in urine over the time interval 0 h to 12 h) | Day 1 |
| fe0-12 (fraction of analyte excreted unchanged in urine from time points 0 h to 12 h) | Day 1 |
| CLR (renal clearance of the analyte in plasma after extravascular administration - based on 0 - 12 hour data) | Day 1 |
| CL/F (apparent clearance of the analyte in the plasma after extravascular administration) | Day 1 |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | Day 1 |
| Cmax,ss (maximum concentration of the analyte in plasma at steady state over a uniform dosing interval) | Day 28 |
| Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval) | Day 28 |
| Cpre,N (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N) | Day 28 |
| Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the last dose) | Day 28 |
| C12,ss (concentration of analyte in plasma at 12 hours post-drug administration at steady state) | Day 28 |
| tmax,ss (time from dosing to maximum concentration at steady state) | Day 28 |
| tmin,ss (time from dosing to minimum concentration during a dosing interval) | Day 28 |
| AUC0-tz,ss (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 last dosing interval) | Day 28 |
| AUC0-12,ss (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 h at steady-state) | Day 28 |
| MRTpo,ss (mean residence time of the analyte in the body after 56 administrations (b.i.d.) at steady state) | Day 28 |
| CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state) | Day 28 |
| Vz/F,ss (apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state) | Day 28 |
| Ae0-12,ss (amount of analyte that is eliminated in urine at steady state over the time interval 0 to 12 h) | Day 28 |
| fe0-12,ss (fraction of analyte excreted unchanged in urine at steady state over the time interval 0 to 12 h) | Day 28 |
| CLR,ss (renal clearance of the analyte at steady state - based on 0 - 12 hour data) | Day 28 |
| RA,Cmax based on Cmax | following 55 doses (bid) |
| RA,AUC based on AUCτ | following 55 doses (bid) |
| Predose concentrations of the analyte in plasma | 5 minutes before drug administration on days 2,3,4,7,14,21,26,27,28 and 29 |
| Change from baseline in UGE, AE0-24 | Day 27 |
| Change from baseline in weighted MDG, AUEC0-24 | Day 27 |
| Epre-corrected AUEC0-5 following OGTT | Day 28 |
| Cavg (average concentration) | day 28 |
| PTF (peak trough fluctuation). | day 28 |
| Mainz |
| Germany |
| 1224.4.49001 Boehringer Ingelheim Investigational Site | Neuss | Germany |
| 1224.4.31001 Boehringer Ingelheim Investigational Site | Zuidlaren | Netherlands |
| D004700 | Endocrine System Diseases |