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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006086-86 | EudraCT Number | EudraCT |
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Assessment of the effect of normal and impaired kidney function on the pharmacokinetics, pharmacodynamics and safety of BI 10773
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 10773 / Group 2 | Experimental | Single Dose Administration (type 2 diabetes and mild renal impairment) |
|
| BI 10773 / Group 3 | Experimental | Single Dose Administration (type 2 diabetes and moderate renal impairment) |
|
| BI 10773 / Group 4 | Experimental | Single Dose Administration (severe renal impairment 8) |
|
| BI 10773 / Group 5 | Experimental | Single Dose Administration (kidney failure) |
|
| BI 10773 / Group 1 | Experimental | Single Dose Administration (type 2 diabetes and normal renal function) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 10773 | Drug | oral administration |
| |
| BI 10773 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ (Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 to Infinity) | Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity. The areas under the curve were calculated using the linear up/log down algorithm. If a drug concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was used. If the drug concentration was smaller than the preceding concentration, the logarithmic method was used. | 1 hour (h) before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration |
| Cmax (Maximum Concentration of the Analyte in Plasma) | Maximum concentration of Empagliflozin in plasma | 1 hour (h) before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Concentration of the Analyte in Plasma | Time from last dosing to maximum concentration of Empagliflozin in plasma (tmax) | 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration |
Not provided
Inclusion criteria:
Exclusion criteria:
Significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders as judged by the investigator.
Relevant gastrointestinal tract surgery
Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or relevant neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts; systolic blood pressure < 100 or > 160 mm Hg, diastolic blood pressure < 60 or > 100 mm Hg, pulse rate < 50 or > 100 1/min
Chronic or relevant acute infections
History of allergy/hypersensitivity (including drug allergies) that are deemed relevant to the trial as judged by the investigator
Use within 10 days prior to administration or during the trial of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation. Co medication known to inhibit or induce P-glycoprotein or CYP3A is not allowed. Inhibitors of P-glycoprotein or CYP3A (cytochrom P3A) are e.g.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1245.12.1 Boehringer Ingelheim Investigational Site | Kiel | Germany | ||||
| 1245.12.2 Boehringer Ingelheim Investigational Site |
Not provided
The trial was conducted in two trial centres as an open-label, parallel group design with one treatment period.
The trial was performed in 40 male and female patients who were assigned to five treatment groups according to their creatinine clearance.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Normal Renal Function | Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Drug |
oral administration |
|
| BI 10773 | Drug | oral administration |
|
| BI 10773 | Drug | oral administration |
|
| BI 10773 | Drug | oral administration |
|
| Half-life and Mean Residence Time of the Analyte in Plasma |
Terminal half-life of Empagliflozin (t1/2) and Mean residence time of Empagliflozin in the body |
| 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration |
| Terminal Rate Constant in Plasma | Terminal rate constant in plasma (Lz) | 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration |
| Apparent Clearance of the Analyte in the Plasma After Extravascular Administration | Apparent clearance of the analyte in the plasma after extravascular administration | 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration |
| Apparent Volume of Distribution During the Terminal Phase Lz | Apparent volume of distribution during the terminal phase Lz | 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration |
| AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point. The areas under the curve were calculated using the linear up/log down algorithm. If a drug concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was used. If the drug concentration was smaller than the preceding concentration, the logarithmic method was used. | 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration |
| Ae0-96 (Amount of Analyte That is Eliminated in Urine Over the Time Interval 0 to 96 h) | Amount of analyte that is eliminated in urine over the time interval 0-96 hours. | 24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration |
| fe0-96 (Fraction of Analyte Excreted Unchanged in Urine From Time Points 0 to 96 Hours) | Fraction of analyte excreted unchanged in urine from time point 0-96 hours. | 24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration |
| Renal Clearance of the Analyte in Plasma After Extravascular Administration | Renal Clearance of the Analyte in Plasma After Extravascular Administration for time interval 0-96 hours. | 24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration |
| %AUCtz-∞ (Percentage of Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From the Time of the Last Quantifiable Data Point Extrapolated to Infinity) | Percentage of area under the concentration-time curve of the analyte in plasma over the time interval from the time of the last quantifiable data point extrapolated to infinity | 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration |
| Plasma Protein Binding | Plasma protein binding is the percent of analyte binding to the plasma protein, pre-dose plasma samples were spiked with Empa 1000 nmol/L. The standard deviation is actually the coefficient of variation. | 1 h before drug administration and 1:30 and 3:00 h after drug administration |
| Total Urinary Glucose Excretion (UGE) | Change from baseline in total urinary glucose excretion | 24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration (Interval 24-0 h before drug administration only for baseline UGE) |
| Safety: Physical Examination, Vital Signs, ECG and Laboratory Measurements | Number of participants with clinically relevant findings in physical examination, Vital Signs, Clinically Significant Abnormalities in Electrocardiogram (ECG) and Significant Changes from Baseline Laboratory Measurements | Drug administration until end-of-study-examination, 5 days |
| Assessment of Tolerability by Investigator | Tolerability was assessed by the investigator based on adverse events and the laboratory evaluation. | Drug administration until end-of-study-examination, 5 days |
| Neuss |
| Germany |
| Mild Renal Impairment |
Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| FG002 | Moderate Renal Impairment | Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| FG003 | Severe Renal Impairment | Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| FG004 | Kidney Failure | Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| COMPLETED |
|
| NOT COMPLETED |
|
The treated set included all patients who were dispensed study medication and were documented to have at least one dose of investigational treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Normal Renal Function | Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| BG001 | Mild Renal Impairment | Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| BG002 | Moderate Renal Impairment | Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| BG003 | Severe Renal Impairment | Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| BG004 | Kidney Failure | Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUC0-∞ (Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 to Infinity) | Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity. The areas under the curve were calculated using the linear up/log down algorithm. If a drug concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was used. If the drug concentration was smaller than the preceding concentration, the logarithmic method was used. | The PK analysis set (PKS) included all evaluable patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 1 hour (h) before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Cmax (Maximum Concentration of the Analyte in Plasma) | Maximum concentration of Empagliflozin in plasma | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 1 hour (h) before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Maximum Concentration of the Analyte in Plasma | Time from last dosing to maximum concentration of Empagliflozin in plasma (tmax) | PKS | Posted | Median | Full Range | h | 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Half-life and Mean Residence Time of the Analyte in Plasma | Terminal half-life of Empagliflozin (t1/2) and Mean residence time of Empagliflozin in the body | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | h | 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Terminal Rate Constant in Plasma | Terminal rate constant in plasma (Lz) | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/h | 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Clearance of the Analyte in the Plasma After Extravascular Administration | Apparent clearance of the analyte in the plasma after extravascular administration | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min | 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Volume of Distribution During the Terminal Phase Lz | Apparent volume of distribution during the terminal phase Lz | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | L | 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point. The areas under the curve were calculated using the linear up/log down algorithm. If a drug concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was used. If the drug concentration was smaller than the preceding concentration, the logarithmic method was used. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Ae0-96 (Amount of Analyte That is Eliminated in Urine Over the Time Interval 0 to 96 h) | Amount of analyte that is eliminated in urine over the time interval 0-96 hours. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol | 24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | fe0-96 (Fraction of Analyte Excreted Unchanged in Urine From Time Points 0 to 96 Hours) | Fraction of analyte excreted unchanged in urine from time point 0-96 hours. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage of analyte | 24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Renal Clearance of the Analyte in Plasma After Extravascular Administration | Renal Clearance of the Analyte in Plasma After Extravascular Administration for time interval 0-96 hours. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min | 24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | %AUCtz-∞ (Percentage of Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From the Time of the Last Quantifiable Data Point Extrapolated to Infinity) | Percentage of area under the concentration-time curve of the analyte in plasma over the time interval from the time of the last quantifiable data point extrapolated to infinity | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | percent | 1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Protein Binding | Plasma protein binding is the percent of analyte binding to the plasma protein, pre-dose plasma samples were spiked with Empa 1000 nmol/L. The standard deviation is actually the coefficient of variation. | PKS | Posted | Mean | Standard Deviation | percentage of plasma protein binding | 1 h before drug administration and 1:30 and 3:00 h after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Urinary Glucose Excretion (UGE) | Change from baseline in total urinary glucose excretion | The UGE analysis set included all patients in the treated set who provided the baseline value from 0 to 24 hours before drug administration and the value for urinary glucose excretion from 0 to 24 hours after drug administration without important protocol violations relevant to the evaluation of Pharmacodynamics. | Posted | Mean | Standard Error | mg | 24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration (Interval 24-0 h before drug administration only for baseline UGE) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Safety: Physical Examination, Vital Signs, ECG and Laboratory Measurements | Number of participants with clinically relevant findings in physical examination, Vital Signs, Clinically Significant Abnormalities in Electrocardiogram (ECG) and Significant Changes from Baseline Laboratory Measurements | Treated set | Posted | Number | participants | Drug administration until end-of-study-examination, 5 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Assessment of Tolerability by Investigator | Tolerability was assessed by the investigator based on adverse events and the laboratory evaluation. | Treated set | Posted | Number | participants | Drug administration until end-of-study-examination, 5 days |
|
From drug administration until end of trial examination, 5 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Renal Function | Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. | 0 | 8 | 1 | 8 | ||
| EG001 | Mild Renal Impairment | Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. | 0 | 9 | 0 | 9 | ||
| EG002 | Moderate Renal Impairment | Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. | 0 | 7 | 1 | 7 | ||
| EG003 | Severe Renal Impairment | Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. | 0 | 8 | 0 | 8 | ||
| EG004 | Kidney Failure | Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. | 0 | 8 | 2 | 8 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MEDDRA 12.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 12.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA 12.1 | Systematic Assessment |
| |
| Erythema | Metabolism and nutrition disorders | MEDDRA 12.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MEDDRA 12.1 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C570240 | empagliflozin |
Not provided
Not provided
Not provided
| Male |
|
| No formal testing, investigation of relative bioavailability | ANOVA | Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status). | Geometric mean ratio | 119.94 | Standard Deviation | 25.6 | 2-Sided | 90 | 96.25 | 149.47 | Standard deviation is actually the geometric Coefficient of Variation [%]. | Yes | Non-Inferiority or Equivalence | Ratio calculated as moderate renal function divided by normal renal function |
| No formal testing, investigation of relative bioavailability | ANOVA | Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status). | Geometric mean ratio | 166.29 | Standard Deviation | 25.6 | 2-Sided | 90 | 134.44 | 205.68 | Standard deviation is actually the geometric Coefficient of Variation [%]. | Yes | Non-Inferiority or Equivalence | Ratio calculated as severe renal function divided by normal renal function |
| No formal testing, investigation of relative bioavailability | ANOVA | Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status). | Geometric mean ratio | 148.29 | Standard Deviation | 25.6 | 2-Sided | 90 | 119.89 | 183.42 | Standard deviation is actually the geometric Coefficient of Variation [%]. | Yes | Non-Inferiority or Equivalence | Ratio calculated as kidney failure divided by normal renal function |
| OG003 | Severe Renal Impairment | Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| OG004 | Kidney Failure | Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
|
|
|
| OG003 | Severe Renal Impairment | Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| OG004 | Kidney Failure | Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
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| OG003 | Severe Renal Impairment | Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| OG004 | Kidney Failure | Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
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| OG003 | Severe Renal Impairment | Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| OG004 | Kidney Failure | Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
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|
| OG003 | Severe Renal Impairment | Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| OG004 | Kidney Failure | Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
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|
| OG003 | Severe Renal Impairment | Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| OG004 | Kidney Failure | Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
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| OG002 | Moderate Renal Impairment | Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| OG003 | Severe Renal Impairment | Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| OG004 | Kidney Failure | Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
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|
| OG003 | Severe Renal Impairment | Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| OG004 | Kidney Failure | Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
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|
| OG003 | Severe Renal Impairment | Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| OG004 | Kidney Failure | Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
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|
| OG003 | Severe Renal Impairment | Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| OG004 | Kidney Failure | Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
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|
Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
| OG003 | Severe Renal Impairment | Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| OG004 | Kidney Failure | Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
|
|
| OG003 | Severe Renal Impairment | Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| OG004 | Kidney Failure | Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
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|
Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².
Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
| OG003 | Severe Renal Impairment | Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| OG004 | Kidney Failure | Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
|
|
| OG003 | Severe Renal Impairment | Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| OG004 | Kidney Failure | Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
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| OG003 |
| Severe Renal Impairment |
Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m². Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
| OG004 | Kidney Failure | Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration. |
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