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Trial record 86 of 187 for:    BI10773

4 Week Treatment With Three Oral Doses of BI 10773 in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00558571
Recruitment Status : Completed
First Posted : November 15, 2007
Results First Posted : August 7, 2014
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: BI 10773 low dose
Drug: placebo to BI 10773
Drug: BI 10773 medium dose
Drug: BI 10773 high dose
Enrollment 78
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Hide Arm/Group Description Oral administration in the fasted state once daily Oral administration in the fasted state once daily. Oral administration in the fasted state once daily. Oral administration in the fasted state once daily.
Period Title: Overall Study
Started 16 16 16 30
Completed 16 16 16 30
Not Completed 0 0 0 0
Arm/Group Title Placebo 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin Total
Hide Arm/Group Description oral administration in the fasted state once daily. oral administration in the fasted state once daily. oral administration in the fasted state once daily. oral administration in the fasted state once daily. Total of all reporting groups
Overall Number of Baseline Participants 16 16 16 30 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 16 participants 16 participants 30 participants 78 participants
57.7  (10.4) 56.8  (8.7) 56.1  (8.5) 56.5  (8.2) 56.7  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 16 participants 30 participants 78 participants
Female
1
   6.3%
3
  18.8%
4
  25.0%
3
  10.0%
11
  14.1%
Male
15
  93.8%
13
  81.3%
12
  75.0%
27
  90.0%
67
  85.9%
1.Primary Outcome
Title Number of Subjects With Drug Related Adverse Events
Hide Description number of subjects with investigator-defined drug-related adverse events.
Time Frame from drug administration up to 6 weeks
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treated set: comprised all 78 patients who received at least one dose of study medication
Arm/Group Title Placebo 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Hide Arm/Group Description:
oral administration in the fasted state once daily.
oral administration in the fasted state once daily.
oral administration in the fasted state once daily.
oral administration in the fasted state once daily.
Overall Number of Participants Analyzed 16 16 16 30
Measure Type: Number
Unit of Measure: participants
7 3 4 14
2.Primary Outcome
Title Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG
Hide Description Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Time Frame from drug administration up to 6 weeks
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treated set
Arm/Group Title Placebo 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Hide Arm/Group Description:
oral administration in the fasted state once daily.
oral administration in the fasted state once daily.
oral administration in the fasted state once daily.
oral administration in the fasted state once daily.
Overall Number of Participants Analyzed 16 16 16 30
Measure Type: Number
Unit of Measure: participants
Lipase increased 0 0 1 2
Blood triglycerides increased 0 1 0 0
Blood creatine phosphokinase increased 0 0 0 1
Ventricular extrasystoles 0 1 0 0
3.Secondary Outcome
Title Cmax of Empagliflozin
Hide Description maximum concentration of the analyte in plasma after first dose (Cmax, Day 1 ) and at steady state over a uniform dosing interval (Cmax,ss, Day 28).
Time Frame 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 hours(h) after drug administration on day 1 and 28
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Pharmacokinetic (PK) analysis set: comprised all 62 patients who received Empagliflozin and had evaluable PK parameter data.
Arm/Group Title 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Hide Arm/Group Description:
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Overall Number of Participants Analyzed 16 16 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Cmax
309
(45.2%)
722
(20%)
2630
(25.8%)
Cmax,ss
259
(24.8%)
687
(18.4%)
2390
(28.1%)
4.Secondary Outcome
Title Tmax of Empagliflozin
Hide Description time from last dosing to maximum concentration of the analyte in plasma after first dose (Day 1), denoted by tmax; and at steady state (Day 28), denoted by tmax,ss.
Time Frame 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28
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PK analysis set
Arm/Group Title 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Hide Arm/Group Description:
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Overall Number of Participants Analyzed 16 16 30
Median (Full Range)
Unit of Measure: hours
tmax
1.50
(1.00 to 2.50)
1.50
(0.75 to 2.00)
1.50
(0.75 to 3.00)
tmax,ss
1.50
(0.98 to 4.00)
1.50
(0.75 to 3.02)
1.50
(0.75 to 6.00)
5.Secondary Outcome
Title t1/2 of Empagliflozin
Hide Description terminal half-life of the analyte in plasma after first dose (Day 1), denoted by t1/2; and at steady state (Day 28), denoted by t1/2,ss.
Time Frame 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28
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PK analysis set
Arm/Group Title 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Hide Arm/Group Description:
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Overall Number of Participants Analyzed 16 16 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
t1/2
8.69
(12.90%)
8.16
(14.50%)
8.53
(18.50%)
t1/2,ss
12.20
(41.40%)
12.70
(32.70%)
15.00
(44.30%)
6.Secondary Outcome
Title AUC0-∞ of Empagliflozin
Hide Description Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) and over a uniform dosing interval τ at steady state (AUCτ,ss)
Time Frame 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1
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Hide Analysis Population Description
PK analysis set
Arm/Group Title 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Hide Arm/Group Description:
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Overall Number of Participants Analyzed 16 16 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
AUC0-∞
1740
(16.4%)
4340
(23.1%)
18000
(24.3%)
AUCτ,ss
1870
(15.9%)
4740
(21.2%)
18700
(25.2%)
7.Secondary Outcome
Title CL/F of Empaglifozin
Hide Description apparent clearance of the analyte in plasma after first dose (CL/F) and at steady state (CL/F,ss)
Time Frame 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28
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PK analysis set
Arm/Group Title 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Hide Arm/Group Description:
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Overall Number of Participants Analyzed 16 16 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/min
CL/F
218
(15.3%)
223
(21.2%)
215
(20.8%)
CL/F,ss
202
(15.9%)
203
(21.4%)
208
(22%)
8.Secondary Outcome
Title fe0-24 of Empagliflozin
Hide Description Fraction of analyte eliminated in urine from time point 0 to 24h after first dose (fe0-24) and at steady state (fe0-24,ss)
Time Frame 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 24:00 h after drug administration on day 1 and 28
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PK analysis set for patients who have fe data at day 1 and day 28
Arm/Group Title 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Hide Arm/Group Description:
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Overall Number of Participants Analyzed 15 16 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: percentage of Empagliflozin
fe0-24 (N=14,16,30)
12.5
(24%)
13.3
(24.5%)
13.7
(34.1%)
fe0-24,ss
18.3
(25%)
17.8
(17.8%)
17.5
(28.3%)
9.Secondary Outcome
Title LI (Linearity Index).
Hide Description The linearity index is defined as AUC0-τ divided by AUC0-∞ both at steady state.
Time Frame 0:05 before drug administration and 0:15 0:30 0:45 1:00 1:30 2:00 2:30 3:00 4:00 6:00 8:00 10:00 12:00 16:00 after drug administration on day 1 and 28
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PK analysis set
Arm/Group Title 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Hide Arm/Group Description:
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Overall Number of Participants Analyzed 16 16 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
1.09
(11.1%)
1.1
(12.5%)
1.04
(9.21%)
10.Secondary Outcome
Title Ae0-24 of Glucose
Hide Description Amount of glucose eliminated in urine over the time interval 0 to 24h on day -2, -1, 1, 27 and 28. (Urinary Glucose Excretion)
Time Frame Day -2 and 27: -2 to 0, 0 to 5, 5 to 12 and 12 to 24h; Day -1 and 1: 0 to 5, 5 to 12 and 12 to 24; Day 28: 0 to 5, 5 to 12, 12 to 24, 24 to 36, 36 to 48 and 48 to 72h
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PD analysis set
Arm/Group Title Placebo 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Hide Arm/Group Description:
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Overall Number of Participants Analyzed 16 16 16 30
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mg
Ae0-24 on day -2 (N=15,16,15,26)
4270
(185%)
7760
(161%)
5340
(123%)
6050
(190%)
Ae0-24 on day -1 (N=13,15,16,25)
6490
(136%)
8450
(114%)
8150
(91%)
6190
(134%)
Ae0-24 on day 1 (N=15,15,16,29)
3970
(197%)
81500
(35.7%)
95700
(30.4%)
87000
(36.9%)
Ae0-24 on day 27 (N=14,13,14,27)
3790
(296%)
78000
(44.1%)
82900
(32.9%)
81300
(50.1%)
Ae0-24 on day 28 (N=13,13,11,23)
6310
(230%)
75400
(44.6%)
83400
(26.4%)
73900
(61.6%)
11.Secondary Outcome
Title Fasting Plasma Glucose (FPG)
Hide Description fasting plasma glucose on day -1 (baseline) and change from baseline to day 28
Time Frame in the morning of days -1 and 28
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PD analysis set
Arm/Group Title Placebo 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Hide Arm/Group Description:
oral administration in the fasted state once daily.
oral administration in the fasted state once daily.
oral administration in the fasted state once daily.
oral administration in the fasted state once daily.
Overall Number of Participants Analyzed 16 16 16 29
Mean (Standard Deviation)
Unit of Measure: mg/dL
baseline (day -1) 153.87  (40.53) 186.18  (92.96) 167.49  (39.61) 149.92  (31.65)
change from baseline to day 28 (N=15, 15, 16, 28) -4.08  (27.08) -43.7  (81.81) -34.22  (26.44) -28.69  (18.25)
12.Secondary Outcome
Title Mean Daily Glucose (MDG) Measured in Blood
Hide Description change from baseline in MDG on the days 1, 7, 14, 21 and 27. Baseline is defined as day -2.
Time Frame 0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day -2. 0:05 h before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00, 13:30, 24:00 h after drug administration on day 1, 7, 14, 21 and 27
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PD analysis set
Arm/Group Title Placebo 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Hide Arm/Group Description:
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Overall Number of Participants Analyzed 16 16 16 30
Mean (Standard Deviation)
Unit of Measure: mg/dL
baseline (day -2) 152.06  (41.49) 164.83  (43.18) 166.26  (35.86) 149.43  (34.94)
change from baseline to day 1 2.13  (18.37) -14.69  (15.81) -23.51  (17.26) -23.02  (16.72)
change from baseline to day 7 -2.4  (15.78) -25.45  (23.2) -28.58  (17.6) -21.17  (21.95)
change from baseline to day 14 2.68  (28.05) -26.97  (27.9) -20.43  (24.69) -12.03  (28.51)
change from baseline to day 21 -3.41  (30.46) -26.47  (31.71) -19.68  (24.94) -13.93  (24.46)
change from baseline to day 27 -4.69  (32.01) -19.57  (28) -26.37  (18.74) -23.87  (18.44)
13.Secondary Outcome
Title Insulin AUEC0-5
Hide Description change in AUEC0-5 from baseline on day 28. Baseline is defined as day -1.
Time Frame 0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.
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PD analysis set
Arm/Group Title Placebo 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Hide Arm/Group Description:
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Overall Number of Participants Analyzed 16 16 16 30
Mean (Standard Deviation)
Unit of Measure: µU*h/mL
baseline (day -1) 108.16  (70.85) 117.34  (54.36) 102.44  (65.8) 121.53  (101.07)
change from baseline to day 28 (N=16, 16, 16, 29) 24.37  (99.44) 3.24  (91.07) 3.8  (73.66) 8.83  (67.79)
14.Secondary Outcome
Title Insulin Emax (Maximum Measured Effect)
Hide Description change in Emax from baseline on day 28. Baseline is defined as day -1
Time Frame 0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.
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PD analysis set
Arm/Group Title Placebo 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Hide Arm/Group Description:
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Overall Number of Participants Analyzed 16 16 16 30
Mean (Standard Deviation)
Unit of Measure: µU/mL
baseline (day -1) 50.78  (28.35) 48.09  (23.38) 46.13  (24.7) 53.06  (43.3)
change from baseline to day 28 (N=16, 16, 16, 29) 7.77  (30.73) 0.55  (36.94) -0.46  (28.46) 2.92  (32.52)
15.Secondary Outcome
Title Fasting Insulin
Hide Description Change from baseline to the days 1, 7, 14, 21 and 28. Baseline is defined as day -1.
Time Frame in the morning of days -1( baseline), 1, 7, 14, 21 and 28
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PD analysis set
Arm/Group Title Placebo 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Hide Arm/Group Description:
oral administration in the fasted state once daily.
oral administration in the fasted state once daily.
oral administration in the fasted state once daily.
oral administration in the fasted state once daily.
Overall Number of Participants Analyzed 16 16 16 30
Mean (Standard Deviation)
Unit of Measure: µU/mL
baseline (day -1) (N=12,12,14,23) 10  (4.37) 11.43  (6.23) 8.74  (4.13) 9.3  (5.14)
change from baseline to day 1 (N=11,12,14,22) -1.08  (2.9) -1.56  (3.97) -1.1  (2.29) 0.15  (4.51)
change from baseline to day 7 (N=9,10,9,18) 0.48  (2.56) -2.49  (6.01) -1  (3.36) -0.2  (6.58)
change from baseline to day 14 (N=12,11,14,22) 2.32  (4.68) -1.16  (4.58) 0.18  (2.74) 1.37  (4.75)
change from baseline to day 21 (N=10,11,14,21) 1.84  (4.76) -0.17  (6.35) -1.21  (2.85) 1.53  (5.87)
change from baseline to day 28 (N=11,11,12,20) -1.2  (1.74) -2.89  (4.68) -1.73  (3.64) -2.1  (4.46)
16.Secondary Outcome
Title Glucagon Emax (Maximum Measured Effect)
Hide Description Change from baseline (day -1) in Emax on day 28.
Time Frame 0:00, 2:30, 5:00, 7:00, 10:00, 12:00, 24:00 h after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.
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PD analysis set
Arm/Group Title Placebo 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Hide Arm/Group Description:
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Overall Number of Participants Analyzed 16 16 16 30
Mean (Standard Deviation)
Unit of Measure: ng/L
baseline (day -1) 80.35  (18.01) 90.58  (19.63) 82.75  (17.79) 86.98  (22.51)
change from baseline to day 28 (N=14, 14, 16, 28) 12.44  (28.69) 13.69  (23.96) 7.84  (16.66) 6.84  (21.45)
17.Secondary Outcome
Title Glucagon AUEC0-5
Hide Description Change from baseline (day -1) in AUEC0-5 on day 28.
Time Frame 0:00, 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day -1. 0:05 before drug administration and 2:30, 5:00, 7:00, 10:00, 12:00 after drug administration on day 28.
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Pharmacodynamic (PD) analysis set: All patients who receive at least one dose of study medication (active drug or placebo) and had some PD data were included in the pharmacodynamic analysis.
Arm/Group Title Placebo 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Hide Arm/Group Description:
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Overall Number of Participants Analyzed 16 16 16 30
Mean (Standard Deviation)
Unit of Measure: ng*h/L
baseline (day -1) 290.66  (74.99) 310.76  (72.1) 291.09  (104.11) 303.06  (75.4)
change from baseline to day 28 (N=14, 14, 16, 28) 9.01  (81.1) 59.69  (89.52) 33.6  (73.09) 40.65  (75.72)
18.Secondary Outcome
Title Fructosamine
Hide Description change from baseline to days 14 and 18. Baseline is defined as day -1.
Time Frame day -1 (baseline), 14 and 28
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PD analysis set
Arm/Group Title Placebo 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Hide Arm/Group Description:
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Oral administration in the fasted state once daily.
Overall Number of Participants Analyzed 16 16 16 30
Mean (Standard Deviation)
Unit of Measure: µmol/L
baseline (day -1) 237.27  (33.97) 251.88  (39.19) 257.88  (53.64) 237.07  (41.48)
change from baseline to day 14 (N=14, 16, 15, 29) 19.57  (24.67) 24.75  (21.55) 13.07  (20.83) 18.31  (22)
change from baseline to day 28 (N=14, 15, 16, 28) -23.57  (28.67) -24.33  (29.98) -22.06  (32.89) -26.29  (31.04)
19.Secondary Outcome
Title HbA1c
Hide Description change from baseline on day 28. Baseline is defined as day -1.
Time Frame in the morning of days -1 and 28
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PD analysis set
Arm/Group Title Placebo 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Hide Arm/Group Description:
Oral administration in the fasted state once daily
Oral administration in the fasted state once daily
Oral administration in the fasted state once daily
Oral administration in the fasted state once daily
Overall Number of Participants Analyzed 16 15 16 30
Mean (Standard Deviation)
Unit of Measure: percentage of hemoglobin
baseline (day -1) 6.89  (0.91) 7.15  (0.67) 7.45  (0.8) 7.1  (0.88)
change from baseline to day 28 (N=13, 13, 15, 28) -0.18  (0.62) -0.27  (0.36) -0.22  (0.32) -0.36  (0.31)
Time Frame From screening (35 to 15 days before treatment administration) until the end of study examination (35 to 41 days after treatment administration)
Adverse Event Reporting Description Patients were required to report spontaneously any AEs, including the time of onset, duration and intensity of these events. Each patient could be assessed by the investigator whenever necessary.
 
Arm/Group Title Placebo 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Hide Arm/Group Description oral administration in the fasted state once daily oral administration in the fasted state once daily oral administration in the fasted state once daily oral administration in the fasted state once daily
All-Cause Mortality
Placebo 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%)   0/16 (0.00%)   0/30 (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 10mg Empagliflozin 25mg Empagliflozin 100mg Empagliflozin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/16 (62.50%)   8/16 (50.00%)   9/16 (56.25%)   18/30 (60.00%) 
Cardiac disorders         
Ventricular extrasystoles  1  0/16 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/30 (0.00%) 
Ear and labyrinth disorders         
Vertigo  1  1/16 (6.25%)  0/16 (0.00%)  0/16 (0.00%)  1/30 (3.33%) 
Gastrointestinal disorders         
Abdominal pain upper  1  0/16 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/30 (0.00%) 
Constipation  1  2/16 (12.50%)  0/16 (0.00%)  1/16 (6.25%)  4/30 (13.33%) 
Diarrhoea  1  0/16 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  1/30 (3.33%) 
Flatulence  1  1/16 (6.25%)  0/16 (0.00%)  0/16 (0.00%)  1/30 (3.33%) 
Gastrooesophageal reflux disease  1  0/16 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/30 (0.00%) 
Toothache  1  0/16 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  2/30 (6.67%) 
General disorders         
Fatigue  1  1/16 (6.25%)  1/16 (6.25%)  0/16 (0.00%)  0/30 (0.00%) 
Pain  1  1/16 (6.25%)  0/16 (0.00%)  0/16 (0.00%)  0/30 (0.00%) 
Pyrexia  1  0/16 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/30 (0.00%) 
Infections and infestations         
Bronchitis  1  0/16 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/30 (0.00%) 
Influenza  1  1/16 (6.25%)  0/16 (0.00%)  0/16 (0.00%)  0/30 (0.00%) 
Nasopharyngitis  1  1/16 (6.25%)  4/16 (25.00%)  0/16 (0.00%)  2/30 (6.67%) 
Sinusitis  1  0/16 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/30 (0.00%) 
Investigations         
Blood triglycerides increased  1  0/16 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/30 (0.00%) 
Lipase increased  1  0/16 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  2/30 (6.67%) 
Metabolism and nutrition disorders         
Hypoglycaemia  1  1/16 (6.25%)  0/16 (0.00%)  0/16 (0.00%)  2/30 (6.67%) 
Musculoskeletal and connective tissue disorders         
Arthritis  1  0/16 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/30 (0.00%) 
Back pain  1  2/16 (12.50%)  1/16 (6.25%)  0/16 (0.00%)  0/30 (0.00%) 
Nervous system disorders         
Headache  1  1/16 (6.25%)  1/16 (6.25%)  3/16 (18.75%)  1/30 (3.33%) 
Renal and urinary disorders         
Pollakiuria  1  1/16 (6.25%)  2/16 (12.50%)  2/16 (12.50%)  3/30 (10.00%) 
Polyuria  1  0/16 (0.00%)  1/16 (6.25%)  0/16 (0.00%)  0/30 (0.00%) 
Reproductive system and breast disorders         
Balanitis  1  0/16 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/30 (0.00%) 
Pruritus genital  1  0/16 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  0/30 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  1/16 (6.25%)  0/16 (0.00%)  1/16 (6.25%)  0/30 (0.00%) 
Hiccups  1  1/16 (6.25%)  0/16 (0.00%)  0/16 (0.00%)  0/30 (0.00%) 
Skin and subcutaneous tissue disorders         
Pruritus  1  0/16 (0.00%)  0/16 (0.00%)  1/16 (6.25%)  1/30 (3.33%) 
Vascular disorders         
Phlebitis  1  0/16 (0.00%)  1/16 (6.25%)  1/16 (6.25%)  0/30 (0.00%) 
Thrombophlebitis  1  0/16 (0.00%)  0/16 (0.00%)  0/16 (0.00%)  5/30 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 11.1
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: NCT00558571     History of Changes
Other Study ID Numbers: 1245.4
EudraCT No 2007-002685-36
First Submitted: November 14, 2007
First Posted: November 15, 2007
Results First Submitted: May 16, 2014
Results First Posted: August 7, 2014
Last Update Posted: August 7, 2014