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Trial record 24 of 187 for:    BI10773

Rel. BA of Empagliflozin (BI 10773)/Linagliptin FDC Tbl, Comparison With Mono-components, With a Second FDC Tablet and Influence of Food

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ClinicalTrials.gov Identifier: NCT01189201
Recruitment Status : Completed
First Posted : August 26, 2010
Results First Posted : March 19, 2015
Last Update Posted : March 19, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: BI 10773/linagliptin
Drug: BI 10773/linagliptin SID
Drug: BI 10773/linagliptin FDC
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Study Overall
Hide Arm/Group Description

A randomised, open label, three period, crossover trial. Each subject was to receive 3 of 4 possible treatments. The treatments were

  • Empagliflozin plus linagliptin fixed dose combination (FDC) A1 (fasted)
  • Empagliflozin plus linagliptin, individual tablets (fasted)
  • Empagliflozin plus linagliptin FDC A1 (fed)
  • Empagliflozin plus linagliptin FDC A3 (fasted)

Drug administrations were separated by a washout period of at least 35 days.

A total of 42 subjects were entered into the study, all subjects were allocated to the FDC A1 (fasted) and individual tablet treatments as this was the primary objective of the study. Along with this 18 of the subjects were allocated to receive the FDC A1 (fed) treatment and other 24 subjects to the FDC A3 treatment.

Period Title: Overall Study
Started 42
Received Empa/Linagliptin FDC A1(Fasted) 42
Rec. Empa/Linagliptin Ind.Tablet(Fasted) 41
Received Empa/Linagliptin FDC A1 (Fed) 18
Received Empa/Linagliptin FDC A3(Fasted) 24
Completed 41
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Study Overall
Hide Arm/Group Description

A randomised, open label, three period, crossover trial. Each subject was to receive 3 of 4 possible treatments. The treatments were

  • Empagliflozin plus linagliptin fixed dose combination (FDC) A1 (fasted)
  • Empagliflozin plus linagliptin, individual tablets (fasted)
  • Empagliflozin plus linagliptin FDC A1 (fed)
  • Empagliflozin plus linagliptin FDC A3 (fasted)

Drug administrations were separated by a washout period of at least 35 days.

A total of 42 subjects were entered into the study, all subjects were allocated to the FDC A1 (fasted) and individual tablet treatments as this was the primary objective of the study. Along with this 18 of the subjects were allocated to receive the FDC A1 (fed) treatment and other 24 subjects to the FDC A3 treatment.

Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants
40.3  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
25
  59.5%
Male
17
  40.5%
1.Primary Outcome
Title Empagliflozin: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)
Hide Description

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

In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h 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 at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin Individual Tablets (Fasted)
Hide Arm/Group Description:
A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
Individual tablets of empa 25 mg and linagliptin 5 mg administered together
Overall Number of Participants Analyzed 42 40
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
5990
(21.0%)
5720
(20.8%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa Plus Linagliptin FDC A1 (Fasted), Empa Plus Linagliptin Individual Tablets (Fasted)
Comments No formal testing, investigation of relative bioavailability
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 104.90
Confidence Interval (2-Sided) 90%
102.07 to 107.80
Parameter Dispersion
Type: Standard Deviation
Value: 7.2
Estimation Comments Standard deviation is actually the geometric coefficient of variation (gCV)
2.Primary Outcome
Title Linagliptin: Area Under the Curve 0 to 72 Hours (AUC0-72)
Hide Description

Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours.

In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h 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 at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin Individual Tablets (Fasted)
Hide Arm/Group Description:
A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
Individual tablets of empa 25 mg and linagliptin 5 mg administered together
Overall Number of Participants Analyzed 42 40
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
264
(22.1%)
250
(22.1%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa Plus Linagliptin FDC A1 (Fasted), Empa Plus Linagliptin Individual Tablets (Fasted)
Comments No formal testing, investigation of relative bioavailability
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 104.91
Confidence Interval (2-Sided) 90%
99.97 to 110.09
Parameter Dispersion
Type: Standard Deviation
Value: 12.8
Estimation Comments Standard deviation is actually the gCV
3.Primary Outcome
Title Empagliflozin: Maximum Measured Concentration (Cmax)
Hide Description

Maximum measured concentration of empagliflozin (empa) in plasma.

In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h 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 at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin Individual Tablets (Fasted)
Hide Arm/Group Description:
A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
Individual tablets of empa 25 mg and linagliptin 5 mg administered together
Overall Number of Participants Analyzed 42 40
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
862
(26.8%)
803
(24.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa Plus Linagliptin FDC A1 (Fasted), Empa Plus Linagliptin Individual Tablets (Fasted)
Comments No formal testing, investigation of relative bioavailability
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 107.68
Confidence Interval (2-Sided) 90%
101.70 to 114.02
Parameter Dispersion
Type: Standard Deviation
Value: 15.3
Estimation Comments Standard deviation is actually the gCV
4.Primary Outcome
Title Linagliptin: Maximum Measured Concentration (Cmax)
Hide Description

Maximum measured concentration of linagliptin in plasma.

In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h 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 at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin Individual Tablets (Fasted)
Hide Arm/Group Description:
A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
Individual tablets of empa 25 mg and linagliptin 5 mg administered together
Overall Number of Participants Analyzed 42 40
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
8.19
(36.4%)
7.49
(31.0%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa Plus Linagliptin FDC A1 (Fasted), Empa Plus Linagliptin Individual Tablets (Fasted)
Comments No formal testing, investigation of relative bioavailability
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 109.68
Confidence Interval (2-Sided) 90%
99.55 to 120.83
Parameter Dispersion
Type: Standard Deviation
Value: 26.2
Estimation Comments Standard deviation is actually the gCV
5.Primary Outcome
Title Empagliflozin Fed vs Fasted: Maximum Measured Concentration (Cmax)
Hide Description

Maximum measured concentration of empagliflozin (empa) in plasma, comparing fed with fasted.

In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h 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 at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin FDC A1 (Fed)
Hide Arm/Group Description:
A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
Overall Number of Participants Analyzed 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
949
(23.7%)
583
(21.7%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa Plus Linagliptin FDC A1 (Fasted), Empa Plus Linagliptin FDC A1 (Fed)
Comments No formal testing, investigation of relative bioavailability
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 61.41
Confidence Interval (2-Sided) 90%
54.10 to 69.71
Parameter Dispersion
Type: Standard Deviation
Value: 22.0
Estimation Comments Standard deviation is actually the gCV
6.Primary Outcome
Title Empagliflozin Fed vs Fasted: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)
Hide Description

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

In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h 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 at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin FDC A1 (Fed)
Hide Arm/Group Description:
A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
Overall Number of Participants Analyzed 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
6330
(16.4%)
5400
(16.3%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa Plus Linagliptin FDC A1 (Fasted), Empa Plus Linagliptin FDC A1 (Fed)
Comments No formal testing, investigation of relative bioavailability
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 85.32
Confidence Interval (2-Sided) 90%
80.77 to 90.14
Parameter Dispersion
Type: Standard Deviation
Value: 9.4
Estimation Comments Standard deviation is actually the gCV
7.Primary Outcome
Title Linagliptin Fed vs Fasted: Maximum Measured Concentration (Cmax)
Hide Description

Maximum measured concentration of linagliptin in plasma.

In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h 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 at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin FDC A1 (Fed)
Hide Arm/Group Description:
A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
Overall Number of Participants Analyzed 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
8.97
(40.0%)
6.14
(17.0%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa Plus Linagliptin FDC A1 (Fasted), Empa Plus Linagliptin FDC A1 (Fed)
Comments No formal testing, investigation of relative bioavailability
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 68.48
Confidence Interval (2-Sided) 90%
58.59 to 80.03
Parameter Dispersion
Type: Standard Deviation
Value: 27.2
Estimation Comments Standard deviation is actually the gCV
8.Primary Outcome
Title Linagliptin Fed vs Fasted: Area Under the Curve 0 to 72 Hours (AUC0-72)
Hide Description

Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours.

In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h 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 at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin FDC A1 (Fed)
Hide Arm/Group Description:
A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
Overall Number of Participants Analyzed 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
275
(21.7%)
250
(19.2%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa Plus Linagliptin FDC A1 (Fasted), Empa Plus Linagliptin FDC A1 (Fed)
Comments No formal testing, investigation of relative bioavailability
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 90.95
Confidence Interval (2-Sided) 90%
84.24 to 98.19
Parameter Dispersion
Type: Standard Deviation
Value: 13.2
Estimation Comments Standard deviation is actually the gCV
9.Primary Outcome
Title Empagliflozin Formulation Comparison: Maximum Measured Concentration (Cmax)
Hide Description

Maximum measured concentration of empagliflozin (empa) in plasma.

In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h 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 at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin FDC A3 (Fasted)
Hide Arm/Group Description:
A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
Overall Number of Participants Analyzed 24 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
802
(27.0%)
787
(25.2%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa Plus Linagliptin FDC A1 (Fasted), Empa Plus Linagliptin FDC A3 (Fasted)
Comments No formal testing, investigation of relative bioavailability
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 98.04
Confidence Interval (2-Sided) 90%
91.95 to 104.53
Parameter Dispersion
Type: Standard Deviation
Value: 13.0
Estimation Comments Standard deviation is actually the gCV
10.Primary Outcome
Title Empagliflozin Formulation Comparison: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)
Hide Description

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

In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h 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 at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin FDC A3 (Fasted)
Hide Arm/Group Description:
A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
Overall Number of Participants Analyzed 24 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
5740
(23.3%)
5490
(21.1%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa Plus Linagliptin FDC A1 (Fasted), Empa Plus Linagliptin FDC A3 (Fasted)
Comments No formal testing, investigation of relative bioavailability
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 95.69
Confidence Interval (2-Sided) 90%
91.17 to 100.43
Parameter Dispersion
Type: Standard Deviation
Value: 9.8
Estimation Comments Standard deviation is actually the gCV
11.Primary Outcome
Title Linagliptin Formulation Comparison: Maximum Measured Concentration (Cmax)
Hide Description

Maximum measured concentration of linagliptin in plasma.

In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h 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 at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin FDC A3 (Fasted)
Hide Arm/Group Description:
A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
Overall Number of Participants Analyzed 24 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
7.65
(32.7%)
7.93
(33.5%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa Plus Linagliptin FDC A1 (Fasted), Empa Plus Linagliptin FDC A3 (Fasted)
Comments No formal testing, investigation of relative bioavailability
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 103.71
Confidence Interval (2-Sided) 90%
92.93 to 115.74
Parameter Dispersion
Type: Standard Deviation
Value: 22.4
Estimation Comments Standard deviation is actually the gCV
12.Primary Outcome
Title Linagliptin Formulation Comparison: Area Under the Curve 0 to 72 Hours (AUC0-72)
Hide Description

Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours.

In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h 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 at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin FDC A3 (Fasted)
Hide Arm/Group Description:
A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
Overall Number of Participants Analyzed 24 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
256
(22.4%)
247
(26.3%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa Plus Linagliptin FDC A1 (Fasted), Empa Plus Linagliptin FDC A3 (Fasted)
Comments No formal testing, investigation of relative bioavailability
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 96.36
Confidence Interval (2-Sided) 90%
89.78 to 103.42
Parameter Dispersion
Type: Standard Deviation
Value: 14.3
Estimation Comments Standard deviation is actually the gCV
13.Secondary Outcome
Title Empagliflozin: Time From Last Dosing to Maximum Measured Concentration (Tmax)
Hide Description Time from last dosing to the maximum measured concentration of empagliflozin (empa) in plasma.
Time Frame 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h 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 at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin Individual Tablets (Fasted) Empa Plus Linagliptin FDC A1 (Fed) Empa Plus Linagliptin FDC A3 (Fasted)
Hide Arm/Group Description:
A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
Individual tablets of empa 25 mg and linagliptin 5 mg administered together
A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
Overall Number of Participants Analyzed 42 40 18 24
Median (Full Range)
Unit of Measure: hours
1.50
(0.67 to 4.00)
1.25
(0.67 to 3.98)
2.00
(0.67 to 4.00)
1.50
(0.67 to 3.00)
14.Secondary Outcome
Title Linagliptin: Time From Last Dosing to Maximum Measured Concentration (Tmax)
Hide Description Time from last dosing to the maximum measured concentration of linagliptin in plasma
Time Frame 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h 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 at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin Individual Tablets (Fasted) Empa Plus Linagliptin FDC A1 (Fed) Empa Plus Linagliptin FDC A3 (Fasted)
Hide Arm/Group Description:
A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
Individual tablets of empa 25 mg and linagliptin 5 mg administered together
A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
Overall Number of Participants Analyzed 42 40 18 24
Median (Full Range)
Unit of Measure: hours
1.50
(0.33 to 6.03)
1.75
(0.67 to 10.0)
2.25
(1.00 to 4.00)
1.50
(0.33 to 4.00)
15.Secondary Outcome
Title Empagliflozin: 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.

In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h 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 at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin Individual Tablets (Fasted)
Hide Arm/Group Description:
A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
Individual tablets of empa 25 mg and linagliptin 5 mg administered together
Overall Number of Participants Analyzed 42 40
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
6060
(20.7%)
5800
(20.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa Plus Linagliptin FDC A1 (Fasted), Empa Plus Linagliptin Individual Tablets (Fasted)
Comments No formal testing, investigation of relative bioavailability
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 104.78
Confidence Interval (2-Sided) 90%
102.02 to 107.61
Parameter Dispersion
Type: Standard Deviation
Value: 7.1
Estimation Comments Standard deviation is actually the gCV
16.Secondary Outcome
Title Linagliptin: Area Under the Curve 0 to Infinity (AUC0-∞)
Hide Description

Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity.

In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h 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 at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin Individual Tablets (Fasted)
Hide Arm/Group Description:
A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
Individual tablets of empa 25 mg and linagliptin 5 mg administered together
Overall Number of Participants Analyzed 42 40
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
435
(26.5%)
410
(29.8%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa Plus Linagliptin FDC A1 (Fasted), Empa Plus Linagliptin Individual Tablets (Fasted)
Comments No formal testing, investigation of relative bioavailability
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 104.64
Confidence Interval (2-Sided) 90%
97.23 to 112.62
Parameter Dispersion
Type: Standard Deviation
Value: 19.7
Estimation Comments Standard deviation is actually the gCV
17.Secondary Outcome
Title Empagliflozin Fed vs Fasted: 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.

In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h 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 at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin FDC A1 (Fed)
Hide Arm/Group Description:
A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
Overall Number of Participants Analyzed 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
6410
(16.0%)
5500
(16.8%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa Plus Linagliptin FDC A1 (Fasted), Empa Plus Linagliptin FDC A1 (Fed)
Comments No formal testing, investigation of relative bioavailability
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 85.86
Confidence Interval (2-Sided) 90%
81.33 to 90.64
Parameter Dispersion
Type: Standard Deviation
Value: 9.3
Estimation Comments Standard deviation is actually the gCV
18.Secondary Outcome
Title Linagliptin Fed vs Fasted: Area Under the Curve 0 to Infinity (AUC0-∞)
Hide Description

Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity.

In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h 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 at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin FDC A1 (Fed)
Hide Arm/Group Description:
A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
Overall Number of Participants Analyzed 18 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
453
(24.2%)
421
(19.0%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa Plus Linagliptin FDC A1 (Fasted), Empa Plus Linagliptin FDC A1 (Fed)
Comments No formal testing, investigation of relative bioavailability
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 93.18
Confidence Interval (2-Sided) 90%
85.07 to 102.05
Parameter Dispersion
Type: Standard Deviation
Value: 15.7
Estimation Comments Standard deviation is actually the gCV
19.Secondary Outcome
Title Empagliflozin Formulation Comparison: 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.

In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h 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 at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin FDC A3 (Fasted)
Hide Arm/Group Description:
A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
Overall Number of Participants Analyzed 24 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
5810
(23.1%)
5560
(20.8%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa Plus Linagliptin FDC A1 (Fasted), Empa Plus Linagliptin FDC A3 (Fasted)
Comments No formal testing, investigation of relative bioavailability
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 95.64
Confidence Interval (2-Sided) 90%
91.19 to 100.30
Parameter Dispersion
Type: Standard Deviation
Value: 9.6
Estimation Comments Standard deviation is actually the gCV
20.Secondary Outcome
Title Linagliptin Formulation Comparison: Area Under the Curve 0 to Infinity (AUC0-∞)
Hide Description

Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity.

In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

Time Frame 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h 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 at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin FDC A3 (Fasted)
Hide Arm/Group Description:
A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
Overall Number of Participants Analyzed 24 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
423
(28.3%)
393
(33.8%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa Plus Linagliptin FDC A1 (Fasted), Empa Plus Linagliptin FDC A3 (Fasted)
Comments No formal testing, investigation of relative bioavailability
Type of Statistical Test Non-Inferiority or Equivalence
Comments Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 92.98
Confidence Interval (2-Sided) 90%
86.36 to 100.09
Parameter Dispersion
Type: Standard Deviation
Value: 14.9
Estimation Comments Standard deviation is actually the gCV
21.Secondary Outcome
Title Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator
Hide Description Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. Time frame for adverse event was until the end-of-study examination.
Time Frame Drug administration until next treatment period/end-of-study examination, up to 36 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set (TS) included all subjects who were documented to have taken at least one dose of investigational treatment.
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin Indivdual Tablets (Fasted) Empa Plus Linagliptin FDC A1 (Fed) Empa Plus Linagliptin FDC A3 (Fasted)
Hide Arm/Group Description:
A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
Individual tablets of empa 25 mg and linagliptin 5 mg administered together
A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
Overall Number of Participants Analyzed 42 41 18 24
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Time Frame Treatment period and following washout period, up to 36 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin Individual Tablets (Fasted) Empa Plus Linagliptin FDC A1 (Fed) Empa Plus Linagliptin FDC A3 (Fasted)
Hide Arm/Group Description A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1) Individual tablets of empa 25 mg and linagliptin 5 mg administered together A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal. A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
All-Cause Mortality
Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin Individual Tablets (Fasted) Empa Plus Linagliptin FDC A1 (Fed) Empa Plus Linagliptin FDC A3 (Fasted)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin Individual Tablets (Fasted) Empa Plus Linagliptin FDC A1 (Fed) Empa Plus Linagliptin FDC A3 (Fasted)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/41 (0.00%)   0/18 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Empa Plus Linagliptin FDC A1 (Fasted) Empa Plus Linagliptin Individual Tablets (Fasted) Empa Plus Linagliptin FDC A1 (Fed) Empa Plus Linagliptin FDC A3 (Fasted)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/42 (19.05%)   5/41 (12.20%)   6/18 (33.33%)   4/24 (16.67%) 
Gastrointestinal disorders         
Abdominal pain  1  0/42 (0.00%)  0/41 (0.00%)  1/18 (5.56%)  1/24 (4.17%) 
Nausea  1  2/42 (4.76%)  0/41 (0.00%)  1/18 (5.56%)  1/24 (4.17%) 
Vomiting  1  2/42 (4.76%)  2/41 (4.88%)  1/18 (5.56%)  1/24 (4.17%) 
Infections and infestations         
Nasopharyngitis  1  1/42 (2.38%)  1/41 (2.44%)  3/18 (16.67%)  0/24 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  1/42 (2.38%)  0/41 (0.00%)  1/18 (5.56%)  0/24 (0.00%) 
Nervous system disorders         
Headache  1  4/42 (9.52%)  4/41 (9.76%)  1/18 (5.56%)  2/24 (8.33%) 
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain  1  0/42 (0.00%)  0/41 (0.00%)  1/18 (5.56%)  0/24 (0.00%) 
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.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
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: NCT01189201     History of Changes
Other Study ID Numbers: 1275.3
2010-019211-38 ( EudraCT Number: EudraCT )
First Submitted: August 25, 2010
First Posted: August 26, 2010
Results First Submitted: March 10, 2015
Results First Posted: March 19, 2015
Last Update Posted: March 19, 2015