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Trial record 38 of 186 for:    BI10773

Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Empagliflozin in Chinese Female and Male Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01316341
Recruitment Status : Completed
First Posted : March 16, 2011
Results First Posted : June 17, 2014
Last Update Posted : June 17, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: BI10773
Drug: Placebo
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Empa 10 mg Empa 25 mg
Hide Arm/Group Description Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). 10 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration. 25 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
Period Title: Overall Study
Started 6 9 9
Completed 6 9 9
Not Completed 0 0 0
Arm/Group Title Placebo Empa 10 mg Empa 25 mg Total
Hide Arm/Group Description Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). 10 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration. 25 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration. Total of all reporting groups
Overall Number of Baseline Participants 6 9 9 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 9 participants 9 participants 24 participants
53.5  (9.6) 54.1  (7.9) 52.7  (9.9) 53.4  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 9 participants 9 participants 24 participants
Female
2
  33.3%
2
  22.2%
6
  66.7%
10
  41.7%
Male
4
  66.7%
7
  77.8%
3
  33.3%
14
  58.3%
1.Primary Outcome
Title Maximum Measured Concentration (Cmax)
Hide Description Maximum measured concentration of the analyte in plasma after the first dose on day 1.
Time Frame 5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
436
(14.1%)
1090
(29.2%)
2.Primary Outcome
Title Time to Maximum Measured Concentration (Tmax)
Hide Description Time from dosing to the maximum measured concentration of the analyte in plasma, after the first dose on day 1.
Time Frame 5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
1.13
(33.3%)
1.50
(40.8%)
3.Primary Outcome
Title Area Under the Curve 0 to Infinity (AUC0-∞) After Single Dosing
Hide Description Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity, after the first dose on day 1
Time Frame 5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
2560
(12.3%)
7250
(24.4%)
4.Primary Outcome
Title Area Under the Curve 0 to the 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, after the first dose on day 1.
Time Frame 5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
2510
(12.3%)
7070
(24.1%)
5.Primary Outcome
Title Terminal Rate Constant (λz)
Hide Description Terminal Rate Constant in Plasma (λz), after the first dose on day 1
Time Frame 5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 1/h
0.0749
(30.3%)
0.0664
(22.2%)
6.Primary Outcome
Title Terminal Half-life (t1/2)
Hide Description Terminal half-life of empagliflozin (empa) in plasma after the first dose on day 1
Time Frame 5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
9.25
(30.3%)
10.4
(22.2%)
7.Primary Outcome
Title Mean Residence Time (MRTpo)
Hide Description Mean residence time of empagliflozin (empa) in the body after the first dose on day 1.
Time Frame 5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
9.29
(16.4%)
10.2
(13.2%)
8.Primary Outcome
Title Apparent Clearance of Empagliflozin After Extravascular Administration (CL/F)
Hide Description Apparent clearance of empagliflozin (empa) in plasma after extravascular administration, after the first dose on day 1.
Time Frame 5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/min
144
(12.3%)
127
(24.4%)
9.Primary Outcome
Title Apparent Volume of Distribution During the Terminal Phase λz (Vz/F)
Hide Description Apparent volume of distribution during the terminal phase λz, after the first dose on day 1.
Time Frame 5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L
115
(31.8%)
115
(30.1%)
10.Primary Outcome
Title Amount of Empagliflozin Eliminated in Urine in the Time Interval 0 Hours to 24 Hours (Ae 0-24)
Hide Description Amount of empagliflozin (empa) eliminated in urine in the time interval 0 hours to 24 hours, after the first dose on day 1.
Time Frame Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol
4030
(18.9%)
9940
(23.8%)
11.Primary Outcome
Title Fraction of Empagliflozin Excreted Unchanged in Urine in the Time Interval 0 Hours to 24 Hours (fe 0-24).
Hide Description Fraction of empagliflozin (empa) excreted unchanged in urine in the time interval 0 hours to 24 hours, after the first dose on day 1.
Time Frame Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: percentage of empa
18.2
(18.9%)
17.9
(23.8%)
12.Primary Outcome
Title Renal Clearance After Extravascular Administration (CL R,0-48)
Hide Description Renal clearance of empagliflozin (empa) in plasma after extravascular administration, after the first dose on day 1.
Time Frame 5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/min
28.9
(22.6%)
25.6
(31.8%)
13.Primary Outcome
Title Maximum Measured Concentration Over a Uniform Dosing Interval (Cmax,ss)
Hide Description Maximum measured concentration of empagliflozin (empa) in plasma at steady state over a uniform dosing interval.
Time Frame 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
489
(27.4%)
1250
(32.1%)
14.Primary Outcome
Title Time From Last Dosing to Maximum Measured Concentration Over a Uniform Dosing Interval at Steady State (Tmax,ss)
Hide Description Time from last dosing to maximum measured concentration of empagliflozin (empa) in plasma over a uniform dosing interval at steady state, after multiple dosing.
Time Frame 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
1.17
(43.8%)
1.37
(35.0%)
15.Primary Outcome
Title Area Under the Concentration-time Curve in Plasma at Steady State Over a Uniform Dosing Interval (AUCτ,ss)
Hide Description Area under the concentration-time curve of empagliflozin (empa) in plasma at steady state over a uniform dosing interval, after multiple dosing
Time Frame 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
2650
(15.4%)
7520
(21.4%)
16.Primary Outcome
Title Terminal Rate Constant in Plasma at Steady State (λz,ss)
Hide Description Terminal rate constant in plasma at steady state, after multiple dosing.
Time Frame 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 1/h
0.0559
(52.5%)
0.0588
(24.6%)
17.Primary Outcome
Title Terminal Half-life in Plasma at Steady State (t1/2,ss)
Hide Description Terminal half-life of empagliflozin (empa) in plasma at steady state, after multiple dosing.
Time Frame 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
12.4
(52.5%)
11.8
(24.6%)
18.Primary Outcome
Title Mean Residence Time at Steady State (MRTpo,ss)
Hide Description Mean residence time of empagliflozin (empa) in the body at steady state after multiple oral administrations
Time Frame 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
10.5
(18.5%)
10.2
(19.1%)
19.Primary Outcome
Title Apparent Clearance of Empagliflozin After Extravascular Administration (CL/Fss)
Hide Description Apparent clearance of empagliflozin (empa) in the plasma at steady state following multiple oral dose administration.
Time Frame 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/min
139
(15.4%)
123
(21.4%)
20.Primary Outcome
Title Apparent Volume of Distribution During the Terminal Phase λz (Vz/Fss)
Hide Description Apparent volume of distribution during the terminal phase λz at steady state following oral administration after multiple dosing
Time Frame 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L
150
(55.1%)
125
(29.9%)
21.Primary Outcome
Title Amount of Analyte Eliminated in Urine at Steady State in Time Interval 0 Hours to 24 Hours (Ae 0-24,ss)
Hide Description Amount of empagliflozin (empa) eliminated in urine at steady state in the time interval 0 hours to 24 hours, after multiple dosing.
Time Frame Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol
4420
(14.6%)
11600
(23.3%)
22.Primary Outcome
Title Fraction of Empagliflozin Excreted Unchanged in Urine at Steady State in the Time Interval 0 Hours to 24 Hours (fe 0-24,ss)
Hide Description Fraction of empagliflozin (empa) excreted unchanged in urine at steady state in the time interval 0 hours to 24 hours, after multiple dosing.
Time Frame Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: percentage of empa
19.9
(14.6%)
20.9
(23.3%)
23.Primary Outcome
Title Renal Clearance at Steady State (CL R,ss)
Hide Description Renal clearance of empagliflozin (empa) in plasma after extravascular administration, after multiple dosing.
Time Frame 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9
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Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/min
27.8
(15.8%)
26.1
(30.0%)
24.Primary Outcome
Title Accumulation Ratio Based on AUC (R A,AUC)
Hide Description Accumulation ratio of empagliflozin (empa) based on AUC, after multiple dosing
Time Frame 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, and16h after drug administration on days 1 and 9
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Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
1.14
(12.0%)
1.17
(11.2%)
25.Primary Outcome
Title Accumulation Ratio Based on Cmax (R A,Cmax)
Hide Description Accumulation ratio of empagliflozin (empa) based on Cmax, after multiple dosing
Time Frame 5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, and16h after drug administration between days 5 and 9
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Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
1.12
(32.0%)
1.15
(30.8%)
26.Primary Outcome
Title Predose Plasma Concentration Before Planned Dose x (Cpre,x)
Hide Description

Predose plasma concentration of empagliflozin (empa) before planned dose by day.

This endpoint in steady state is identical to Cmin,ss.

Time Frame 5 minutes before drug administration
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Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.
Arm/Group Title Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
A single dose of 10 mg Empagliflozin (empa) taken orally, plus one placebo tablet.
A single dose of 25 mg empagliflozin (empa) taken orally, plus one placebo tablet.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Treatment Day 5
24.64
(1.24%)
70.54
(1.48%)
Treatment Day 6
25.70
(1.23%)
80.27
(1.42%)
Treatment Day 7
25.24
(1.24%)
78.96
(1.57%)
Treatment Day 8
26.10
(1.22%)
72.74
(1.43%)
Treatment Day 9
27.21
(1.23%)
76.02
(1.42%)
27.Primary Outcome
Title Urinary Glucose Excretion (UGE) Change From Baseline
Hide Description Change from day -1 in urinary glucose excretion in a 24 hour collection period per time point.
Time Frame Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration
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Hide Analysis Population Description
Pharmacodynamic analysis (PD) set included all patients documented to have taken at least one dose of investigational treatment, who received at least one dose of empagliflozin or placebo and who provided at least one baseline and post-treatment observation for at least one PD endpoint.
Arm/Group Title Placebo Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally for 7 consecutive days.
10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
Overall Number of Participants Analyzed 6 9 9
Mean (Standard Deviation)
Unit of Measure: mg
Day 1 -988.38  (2791.68) 87680.85  (22924.91) 82791.86  (18752.81)
Day 9 -4106.10  (6428.12) 95765.72  (24133.47) 82633.88  (34757.02)
28.Primary Outcome
Title Fasting Plasma Glucose (FPG) Change From Baseline
Hide Description Fasting Plasma Glucose (FPG) change from baseline between day 1 and day 9.
Time Frame Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration
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Hide Analysis Population Description
Pharmacodynamic analysis (PD) set included all patients documented to have taken at least one dose of investigational treatment, who received at least one dose of empagliflozin or placebo and who provided at least one baseline and post-treatment observation for at least one PD endpoint.
Arm/Group Title Placebo Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally for 7 consecutive days.
10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
Overall Number of Participants Analyzed 6 9 9
Mean (Standard Deviation)
Unit of Measure: mg/dL
-3.67  (7.45) -25.56  (20.74) -31.44  (26.92)
29.Secondary Outcome
Title Clinical Relevant Abnormalities for Protocol-Specified Significant Adverse Events, Hypoglycaemic Events, Vital Signs, Blood Chemistry, Rescue Therapy, Body Weight and Waist Circumference
Hide Description

Clinically relevant abnormalities for protocol-specified significant adverse events, hypoglycaemic events, vital signs, blood chemistry, use of rescue therapy, change in body weight and change in waist circumference.

Results shown are for hypoglycaemic events, as this was the only event that occurred for this endpoint.

Time Frame Drug administration until end of trial, up to 21 days
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Hide Analysis Population Description
Treated set (TS) includes all patients who were documented to have taken at least one dose of investigational treatment.
Arm/Group Title Placebo Empa 10 mg Empa 25 mg
Hide Arm/Group Description:
Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period).
10 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration.
25 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
Overall Number of Participants Analyzed 6 9 9
Measure Type: Number
Unit of Measure: participants
0 1 0
Time Frame Drug administration until end of trial, up to 21 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Empa 10 mg Empa 25 mg
Hide Arm/Group Description Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). 10 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration. 25 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
All-Cause Mortality
Placebo Empa 10 mg Empa 25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Empa 10 mg Empa 25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/9 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Empa 10 mg Empa 25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/6 (50.00%)   4/9 (44.44%)   2/9 (22.22%) 
Blood and lymphatic system disorders       
White blood cell disorder  1  0/6 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Gastrointestinal disorders       
Diarrhoea  1  1/6 (16.67%)  1/9 (11.11%)  0/9 (0.00%) 
Toothache  1  1/6 (16.67%)  2/9 (22.22%)  1/9 (11.11%) 
Investigations       
Eosinophil count abnormal  1  1/6 (16.67%)  0/9 (0.00%)  0/9 (0.00%) 
Neutrophil count abnormal  1  0/6 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Renal and urinary disorders       
Pollakiuria  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%) 
Skin and subcutaneous tissue disorders       
Pruritus  1  1/6 (16.67%)  2/9 (22.22%)  0/9 (0.00%) 
Purpura  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 14.1
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: NCT01316341     History of Changes
Other Study ID Numbers: 1245.44
First Submitted: March 15, 2011
First Posted: March 16, 2011
Results First Submitted: May 16, 2014
Results First Posted: June 17, 2014
Last Update Posted: June 17, 2014