Trial Outcomes & Findings for Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Extended Release (XR) Compared With Single Tablets (NCT NCT02106923)
NCT ID: NCT02106923
Last Updated: 2017-03-09
Results Overview
Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
72 participants
Primary outcome timeframe
1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Results posted on
2017-03-09
Participant Flow
Participant milestones
| Measure |
Empa+1000mg Met FDC / Empa+1000mg Glumetza® (Fasted)
Oral administration of 1 x 10 mg Empagliflozin (Empa)/1000 mg metformin (Met) extended release (XR) fixed dose combination (FDC) followed by oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (h).
|
Empa+1000mg Glumetza / Empa+1000mg Met FDC (Fasted)
Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR followed by oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR FDC. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h.
|
Empa+1000mg Met FDC / Empa+1000mg Glumetza (Fed)
Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC followed by oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal.
|
Empa+1000mg Glumetza / Empa+1000mg Met FDC (Fed)
Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR followed by oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal.
|
Empa+1500mg Met FDC / Empa+1500mg Glumetza (Fasted)
Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC followed by oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h.
|
Empa+1500mg Glumetza / Empa+1500mg Met FDC (Fasted)
Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR followed by oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
12
|
12
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Empa+1000mg Met FDC / Empa+1000mg Glumetza® (Fasted)
Oral administration of 1 x 10 mg Empagliflozin (Empa)/1000 mg metformin (Met) extended release (XR) fixed dose combination (FDC) followed by oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (h).
|
Empa+1000mg Glumetza / Empa+1000mg Met FDC (Fasted)
Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR followed by oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR FDC. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h.
|
Empa+1000mg Met FDC / Empa+1000mg Glumetza (Fed)
Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC followed by oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal.
|
Empa+1000mg Glumetza / Empa+1000mg Met FDC (Fed)
Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR followed by oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal.
|
Empa+1500mg Met FDC / Empa+1500mg Glumetza (Fasted)
Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC followed by oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h.
|
Empa+1500mg Glumetza / Empa+1500mg Met FDC (Fasted)
Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR followed by oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h.
|
|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Extended Release (XR) Compared With Single Tablets
Baseline characteristics by cohort
| Measure |
1000mg, Fasted
n=24 Participants
Patients orally administered either 1 x 10 mg Empagliflozin/1000 mg metformin (Met) XR FDC or 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (h).
|
1000mg, Fed
n=24 Participants
Patients orally administered either 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC or 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal
|
1500mg, Fasted
n=24 Participants
Patients orally administered either 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC or 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28.5 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
31.3 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
30.7 years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administrationPopulation: Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.
Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Outcome measures
| Measure |
Empa/1000 mg Glumetza® (Fasted)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
|
Empa/ 1000 mg Met FDC (Fasted)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
|
Empa/1000 mg Glumetza ® (Fed)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
|
Empa/ 1000 mg Met FDC (Fed)
n=23 Participants
Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
|
Empa/ 1500 mg Glumetza® (Fasted)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
|
Empa/ 1500 mg Met FDC (Fasted)
n=23 Participants
Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
|
|---|---|---|---|---|---|---|
|
AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point), for Empagliflozin
|
2630 nmol*h/L
Geometric Coefficient of Variation 18.9
|
2710 nmol*h/L
Geometric Coefficient of Variation 18.3
|
2720 nmol*h/L
Geometric Coefficient of Variation 20.5
|
2710 nmol*h/L
Geometric Coefficient of Variation 19.9
|
2790 nmol*h/L
Geometric Coefficient of Variation 17.3
|
2680 nmol*h/L
Geometric Coefficient of Variation 18.7
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administrationPopulation: Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.
Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point
Outcome measures
| Measure |
Empa/1000 mg Glumetza® (Fasted)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
|
Empa/ 1000 mg Met FDC (Fasted)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
|
Empa/1000 mg Glumetza ® (Fed)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
|
Empa/ 1000 mg Met FDC (Fed)
n=23 Participants
Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
|
Empa/ 1500 mg Glumetza® (Fasted)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
|
Empa/ 1500 mg Met FDC (Fasted)
n=23 Participants
Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
|
|---|---|---|---|---|---|---|
|
AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Metformin
|
7020 ng*h/mL
Geometric Coefficient of Variation 35.2
|
7170 ng*h/mL
Geometric Coefficient of Variation 36.2
|
13500 ng*h/mL
Geometric Coefficient of Variation 19.1
|
13200 ng*h/mL
Geometric Coefficient of Variation 18.8
|
9860 ng*h/mL
Geometric Coefficient of Variation 26.4
|
10100 ng*h/mL
Geometric Coefficient of Variation 25.6
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administrationPopulation: Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.
Maximum measured concentration of empagliflozin in plasma (Cmax).
Outcome measures
| Measure |
Empa/1000 mg Glumetza® (Fasted)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
|
Empa/ 1000 mg Met FDC (Fasted)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
|
Empa/1000 mg Glumetza ® (Fed)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
|
Empa/ 1000 mg Met FDC (Fed)
n=23 Participants
Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
|
Empa/ 1500 mg Glumetza® (Fasted)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
|
Empa/ 1500 mg Met FDC (Fasted)
n=23 Participants
Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
|
|---|---|---|---|---|---|---|
|
Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Empagliflozin
|
377 nmol/L
Geometric Coefficient of Variation 22.5
|
395 nmol/L
Geometric Coefficient of Variation 24.6
|
273 nmol/L
Geometric Coefficient of Variation 27.6
|
277 nmol/L
Geometric Coefficient of Variation 31.0
|
396 nmol/L
Geometric Coefficient of Variation 21.9
|
381 nmol/L
Geometric Coefficient of Variation 22.0
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administrationPopulation: Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.
Maximum measured concentration of metformin in plasma
Outcome measures
| Measure |
Empa/1000 mg Glumetza® (Fasted)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
|
Empa/ 1000 mg Met FDC (Fasted)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
|
Empa/1000 mg Glumetza ® (Fed)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
|
Empa/ 1000 mg Met FDC (Fed)
n=23 Participants
Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
|
Empa/ 1500 mg Glumetza® (Fasted)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
|
Empa/ 1500 mg Met FDC (Fasted)
n=23 Participants
Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
|
|---|---|---|---|---|---|---|
|
Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Metformin
|
975 ng/mL
Geometric Coefficient of Variation 37.2
|
964 ng/mL
Geometric Coefficient of Variation 39.9
|
1110 ng/mL
Geometric Coefficient of Variation 21.2
|
1200 ng/mL
Geometric Coefficient of Variation 22.7
|
1220 ng/mL
Geometric Coefficient of Variation 32.8
|
1270 ng/mL
Geometric Coefficient of Variation 34.7
|
SECONDARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administrationPopulation: Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.
Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity).
Outcome measures
| Measure |
Empa/1000 mg Glumetza® (Fasted)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
|
Empa/ 1000 mg Met FDC (Fasted)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
|
Empa/1000 mg Glumetza ® (Fed)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
|
Empa/ 1000 mg Met FDC (Fed)
n=23 Participants
Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
|
Empa/ 1500 mg Glumetza® (Fasted)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
|
Empa/ 1500 mg Met FDC (Fasted)
n=23 Participants
Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
|
|---|---|---|---|---|---|---|
|
AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Empagliflozin
|
2680 nmol*h/L
Geometric Coefficient of Variation 18.7
|
2760 nmol*h/L
Geometric Coefficient of Variation 17.9
|
2790 nmol*h/L
Geometric Coefficient of Variation 21.3
|
2770 nmol*h/L
Geometric Coefficient of Variation 20.2
|
2840 nmol*h/L
Geometric Coefficient of Variation 17.4
|
2740 nmol*h/L
Geometric Coefficient of Variation 19.5
|
SECONDARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administrationPopulation: Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.
Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity
Outcome measures
| Measure |
Empa/1000 mg Glumetza® (Fasted)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
|
Empa/ 1000 mg Met FDC (Fasted)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
|
Empa/1000 mg Glumetza ® (Fed)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
|
Empa/ 1000 mg Met FDC (Fed)
n=23 Participants
Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
|
Empa/ 1500 mg Glumetza® (Fasted)
n=24 Participants
Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
|
Empa/ 1500 mg Met FDC (Fasted)
n=23 Participants
Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
|
|---|---|---|---|---|---|---|
|
AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Metformin
|
7480 ng*h/mL
Geometric Coefficient of Variation 37.4
|
7360 ng*h/mL
Geometric Coefficient of Variation 36.7
|
13900 ng*h/mL
Geometric Coefficient of Variation 20.7
|
13600 ng*h/mL
Geometric Coefficient of Variation 20.4
|
10500 ng*h/mL
Geometric Coefficient of Variation 28.5
|
10900 ng*h/mL
Geometric Coefficient of Variation 28.7
|
Adverse Events
Empa/1000 mg Glumetza® (Fasted)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Empa/ 1000 mg Met FDC (Fasted)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Empa/1000 mg Glumetza ® (Fed)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Empa/ 1000 mg Met FDC (Fed)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Empa/ 1500 mg Glumetza® (Fasted)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Empa/ 1500 mg Met FDC (Fasted)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Empa/1000 mg Glumetza® (Fasted)
n=24 participants at risk
Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
|
Empa/ 1000 mg Met FDC (Fasted)
n=24 participants at risk
Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
|
Empa/1000 mg Glumetza ® (Fed)
n=24 participants at risk
Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
|
Empa/ 1000 mg Met FDC (Fed)
n=24 participants at risk
Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
|
Empa/ 1500 mg Glumetza® (Fasted)
n=24 participants at risk
Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
|
Empa/ 1500 mg Met FDC (Fasted)
n=23 participants at risk
Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
4.2%
1/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
8.3%
2/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
0.00%
0/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
0.00%
0/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
8.3%
2/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
8.7%
2/23 • From drug administration until next treatment period or follow-up visit, 10 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
2/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
0.00%
0/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
0.00%
0/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
0.00%
0/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
0.00%
0/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
0.00%
0/23 • From drug administration until next treatment period or follow-up visit, 10 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
4.2%
1/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
0.00%
0/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
4.2%
1/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
12.5%
3/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
8.7%
2/23 • From drug administration until next treatment period or follow-up visit, 10 days
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
2/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
8.3%
2/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
0.00%
0/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
8.3%
2/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
0.00%
0/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
17.4%
4/23 • From drug administration until next treatment period or follow-up visit, 10 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
4.2%
1/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
16.7%
4/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
8.3%
2/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
4.2%
1/24 • From drug administration until next treatment period or follow-up visit, 10 days
|
4.3%
1/23 • From drug administration until next treatment period or follow-up visit, 10 days
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER