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Trial record 8 of 186 for:    BI10773

Pharmacokinetics of Empagliflozin (BI 10773) in Patients With Impaired Liver Function

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ClinicalTrials.gov Identifier: NCT01111318
Recruitment Status : Completed
First Posted : April 27, 2010
Results First Posted : June 13, 2014
Last Update Posted : June 13, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hepatic Insufficiency
Healthy
Intervention Drug: BI 10773
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Healthy Mild Moderate Severe
Hide Arm/Group Description Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight. Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A. Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B. Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
Period Title: Overall Study
Started 12 8 8 8
Completed 12 8 8 8
Not Completed 0 0 0 0
Arm/Group Title Healthy Mild Moderate Severe Total
Hide Arm/Group Description Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight. Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A. Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B. Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C. Total of all reporting groups
Overall Number of Baseline Participants 12 8 8 8 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 8 participants 8 participants 8 participants 36 participants
53.8  (9.2) 57.0  (6.9) 51.0  (8.5) 53.9  (9.6) 53.9  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 8 participants 8 participants 8 participants 36 participants
Female
8
  66.7%
4
  50.0%
3
  37.5%
4
  50.0%
19
  52.8%
Male
4
  33.3%
4
  50.0%
5
  62.5%
4
  50.0%
17
  47.2%
1.Primary Outcome
Title Area Under the Curve 0 to Infinity (AUC0-∞)
Hide Description

Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.

The standard deviation is actually the coefficient of variation. The 'measured values' show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.
Arm/Group Title Healthy Mild Moderate Severe
Hide Arm/Group Description:
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
Overall Number of Participants Analyzed 12 8 8 8
Mean (Standard Deviation)
Unit of Measure: nmol*h/L
10800  (22.6) 13800  (38.6) 16100  (26.2) 19000  (27.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Healthy, Mild
Comments Ratio calculated as mild divided by healthy
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 123.15
Confidence Interval (2-Sided) 90%
98.89 to 153.36
Parameter Dispersion
Type: Standard Deviation
Value: 29.0
Estimation Comments Standard deviation is actually the geometric coefficient of variation
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Healthy, Moderate
Comments Ratio calculated as moderate divided by healthy
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 146.97
Confidence Interval (2-Sided) 90%
118.02 to 183.02
Parameter Dispersion
Type: Standard Deviation
Value: 29.0
Estimation Comments Standard deviation is actually the geometric coefficient of variation
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Healthy, Severe
Comments Ratio calculated as severe divided by healthy
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 174.70
Confidence Interval (2-Sided) 90%
140.29 to 217.55
Parameter Dispersion
Type: Standard Deviation
Value: 29.0
Estimation Comments Standard deviation is actually the geometric coefficient of variation
2.Primary Outcome
Title Maximum Measured Concentration (Cmax)
Hide Description

Maximum measured concentration of empagliflozin (empa) in plasma.

The standard deviation is actually the coefficient of variation. The 'measured values' show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.
Arm/Group Title Healthy Mild Moderate Severe
Hide Arm/Group Description:
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
Overall Number of Participants Analyzed 12 8 8 8
Mean (Standard Deviation)
Unit of Measure: nmol/L
1370  (33.9) 1430  (36.8) 1660  (26.4) 1970  (22.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Healthy, Mild
Comments Ratio calculated as mild divided by healthy
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 103.81
Confidence Interval (2-Sided) 90%
82.29 to 130.95
Parameter Dispersion
Type: Standard Deviation
Value: 30.7
Estimation Comments Standard deviation is actually the geometric coefficient of variation
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Healthy, Moderate
Comments Ratio calculated as moderate divided by healthy
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 123.31
Confidence Interval (2-Sided) 90%
97.74 to 155.55
Parameter Dispersion
Type: Standard Deviation
Value: 30.7
Estimation Comments Standard deviation is actually the geometric coefficient of variation
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Healthy, Severe
Comments Ratio calculated as severe divided by healthy
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 148.41
Confidence Interval (2-Sided) 90%
117.65 to 187.23
Parameter Dispersion
Type: Standard Deviation
Value: 30.7
Estimation Comments Standard deviation is actually the geometric coefficient of variation
3.Secondary Outcome
Title Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)
Hide Description

Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.

The standard deviation is actually the coefficient of variation.

Time Frame Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.
Arm/Group Title Healthy Mild Moderate Severe
Hide Arm/Group Description:
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
Overall Number of Participants Analyzed 12 8 8 8
Mean (Standard Deviation)
Unit of Measure: nmol*h/L
10700  (22.6) 13700  (38.4) 15800  (25.7) 18600  (23.9)
4.Secondary Outcome
Title Time From Dosing to Maximum Concentration (Tmax)
Hide Description Time from dosing to maximum concentration of empagliflozin (empa) in plasma.
Time Frame Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.
Arm/Group Title Healthy Mild Moderate Severe
Hide Arm/Group Description:
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
Overall Number of Participants Analyzed 12 8 8 8
Median (Full Range)
Unit of Measure: h
2.00
(1.00 to 4.00)
1.50
(0.67 to 4.00)
2.00
(0.67 to 2.50)
1.50
(0.67 to 2.50)
5.Secondary Outcome
Title Terminal Rate Constant (λz)
Hide Description

Terminal rate constant in plasma.

The standard deviation is actually the coefficient of variation.

Time Frame Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.
Arm/Group Title Healthy Mild Moderate Severe
Hide Arm/Group Description:
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
Overall Number of Participants Analyzed 12 8 8 8
Mean (Standard Deviation)
Unit of Measure: 1/h
0.0414  (41.6) 0.0404  (23.5) 0.0454  (28.9) 0.0506  (41.1)
6.Secondary Outcome
Title Terminal Half-Life (t1/2)
Hide Description

Terminal half-life of empagliflozin (empa) in plasma.

The standard deviation is actually the coefficient of variation.

Time Frame Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.
Arm/Group Title Healthy Mild Moderate Severe
Hide Arm/Group Description:
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
Overall Number of Participants Analyzed 12 8 8 8
Mean (Standard Deviation)
Unit of Measure: h
19.9  (43.1) 18.1  (25.9) 17.1  (45.9) 17.7  (67.4)
7.Secondary Outcome
Title Mean Residence Time (MRTpo)
Hide Description

Mean residence time of empagliflozin (empa) in the body.

The standard deviation is actually the coefficient of variation.

Time Frame Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.
Arm/Group Title Healthy Mild Moderate Severe
Hide Arm/Group Description:
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
Overall Number of Participants Analyzed 12 8 8 8
Mean (Standard Deviation)
Unit of Measure: h
13.2  (31.3) 14.4  (22.9) 15.5  (37.2) 15.7  (43.0)
8.Secondary Outcome
Title Apparent Clearance After Extravascular Administration (CL/F)
Hide Description

Apparent clearance of empagliflozin (empa) in the plasma after extravascular administration.

The standard deviation is actually the coefficient of variation.

Time Frame Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.
Arm/Group Title Healthy Mild Moderate Severe
Hide Arm/Group Description:
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
Overall Number of Participants Analyzed 12 8 8 8
Mean (Standard Deviation)
Unit of Measure: mL/min
179  (23.9) 150  (34.4) 124  (30.7) 103  (23.0)
9.Secondary Outcome
Title Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Hide Description

Apparent volume of distribution during the terminal phase (λz).

The standard deviation is actually the coefficient of variation.

Time Frame Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.
Arm/Group Title Healthy Mild Moderate Severe
Hide Arm/Group Description:
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
Overall Number of Participants Analyzed 12 8 8 8
Mean (Standard Deviation)
Unit of Measure: L
298  (39.5) 237  (45.5) 173  (35.0) 144  (46.7)
10.Secondary Outcome
Title Amount of Empagliflozin That is Eliminated in Urine (Ae0-96)
Time Frame Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.
Arm/Group Title Healthy Mild Moderate Severe
Hide Arm/Group Description:
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
Overall Number of Participants Analyzed 12 8 8 8
Mean (Standard Deviation)
Unit of Measure: nmol
18400  (26.5) 16900  (20.6) 18500  (35.0) 22500  (23.5)
11.Secondary Outcome
Title Fraction of Empagliflozin Excreted Unchanged in Urine (fe0-96))
Hide Description

Fraction of empagliflozin (empa) excreted unchanged in urine from time points 0 to 96 hours.

The standard deviation is actually the coefficient of variation.

Time Frame Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.
Arm/Group Title Healthy Mild Moderate Severe
Hide Arm/Group Description:
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
Overall Number of Participants Analyzed 12 8 8 8
Mean (Standard Deviation)
Unit of Measure: percentage of empagliflozin
16.6  (26.5) 15.2  (20.6) 16.7  (35.0) 20.3  (23.5)
12.Secondary Outcome
Title Renal Clearance After Extravascular Administration (CL R)
Hide Description

Renal clearance of empagliflozin (empa) in plasma after extravascular administration.

The standard deviation is actually the coefficient of variation.

Time Frame Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.
Arm/Group Title Healthy Mild Moderate Severe
Hide Arm/Group Description:
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
Overall Number of Participants Analyzed 12 8 8 8
Mean (Standard Deviation)
Unit of Measure: mL/min
28.7  (30.3) 23.7  (48.0) 19.9  (36.8) 21.3  (37.1)
13.Secondary Outcome
Title Urinary Glucose Excretion (UGE)
Hide Description

Urinary glucose excretion, this endpoint was measured using Ae0-96.

The standard deviation is actually the coefficient of variation.

Time Frame Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.
Arm/Group Title Healthy Mild Moderate Severe
Hide Arm/Group Description:
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
Overall Number of Participants Analyzed 12 7 8 8
Mean (Standard Deviation)
Unit of Measure: mg
86600  (34.8) 81000  (26.7) 79700  (67.9) 79800  (45.6)
14.Secondary Outcome
Title Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator
Hide Description Clinically relevant abnormalities for physical examination, vital signs, ECG, clinical laboratory tests and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events (AE).
Time Frame Drug administration until 4 days after drug administration or end-of-study visit, up to 19 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set (TS) included all subjects who had been dispensed study medication and were documented to have taken the investigational treatment.
Arm/Group Title Healthy Mild Moderate Severe
Hide Arm/Group Description:
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
Overall Number of Participants Analyzed 12 8 8 8
Measure Type: Number
Unit of Measure: participants
Investigations: Electrocardiogram abnormal 2 0 0 0
Investigations: Nitrite urine present 0 0 0 1
Time Frame Drug administration until 4 days after drug administration or end-of-study visit, up to 19 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Mild Moderate Severe
Hide Arm/Group Description Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight. Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A. Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B. Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
All-Cause Mortality
Healthy Mild Moderate Severe
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Healthy Mild Moderate Severe
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Healthy Mild Moderate Severe
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/12 (50.00%)   0/8 (0.00%)   3/8 (37.50%)   2/8 (25.00%) 
Cardiac disorders         
Myocardial ischaemia  1  0/12 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/8 (0.00%) 
Gastrointestinal disorders         
Constipation  1  4/12 (33.33%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Toothache  1  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
General disorders         
Pyrexia  1  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Infections and infestations         
Asymptomatic bacteriuria  1  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Investigations         
Electrocardiogram abnormal  1  2/12 (16.67%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Nitrite urine present  1  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%) 
Nervous system disorders         
Headache  1  3/12 (25.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%) 
Renal and urinary disorders         
Leukocyturia  1  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01111318     History of Changes
Other Study ID Numbers: 1245.13
2009-017202-36 ( EudraCT Number: EudraCT )
First Submitted: April 26, 2010
First Posted: April 27, 2010
Results First Submitted: May 16, 2014
Results First Posted: June 13, 2014
Last Update Posted: June 13, 2014