Trial Outcomes & Findings for Relative Bioavailability of 2 Fixed Dose Combinations of Linagliptin/Metformin Compared With Single Tablets (NCT NCT01845077)
NCT ID: NCT01845077
Last Updated: 2014-08-19
Results Overview
Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
72 participants
Primary outcome timeframe
1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period
Results posted on
2014-08-19
Participant Flow
Participant milestones
| Measure |
FDC1000 Fasted, Then L+M1000 Fasted
1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
|
L+M1000 Fasted, Then FDC1000 Fasted
1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
|
FDC1000 Fed, Then L+M1000 Fed
1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the first treatment period orally in the morning under fed conditions, then 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fed conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
|
L+M1000 Fed, Then FDC1000 Fed
1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fed conditions, then 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fed conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
|
FDC1500 Fasted, Then L+M1500 Fasted
2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
|
L+M1500 Fasted, Then FDC1500 Fasted
1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
12
|
12
|
12
|
12
|
12
|
12
|
|
Treatment Period 1
COMPLETED
|
12
|
12
|
12
|
12
|
12
|
12
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period
STARTED
|
12
|
12
|
12
|
12
|
12
|
12
|
|
Washout Period
COMPLETED
|
11
|
11
|
11
|
10
|
11
|
11
|
|
Washout Period
NOT COMPLETED
|
1
|
1
|
1
|
2
|
1
|
1
|
|
Treatment Period 2
STARTED
|
11
|
11
|
11
|
10
|
11
|
11
|
|
Treatment Period 2
COMPLETED
|
11
|
11
|
11
|
10
|
11
|
11
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
FDC1000 Fasted, Then L+M1000 Fasted
1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
|
L+M1000 Fasted, Then FDC1000 Fasted
1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
|
FDC1000 Fed, Then L+M1000 Fed
1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the first treatment period orally in the morning under fed conditions, then 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fed conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
|
L+M1000 Fed, Then FDC1000 Fed
1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fed conditions, then 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fed conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
|
FDC1500 Fasted, Then L+M1500 Fasted
2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
|
L+M1500 Fasted, Then FDC1500 Fasted
1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
|
|---|---|---|---|---|---|---|
|
Washout Period
Lost to Follow-up
|
0
|
1
|
0
|
1
|
0
|
1
|
|
Washout Period
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period
elevated lab values (not clinic. sign.)
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Washout Period
Protocol Violation
|
0
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Relative Bioavailability of 2 Fixed Dose Combinations of Linagliptin/Metformin Compared With Single Tablets
Baseline characteristics by cohort
| Measure |
Total 1000 Fasted
n=24 Participants
Patients were administered 1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) orally in the morning under fasted conditions in one treatment period and 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR orally in the morning under fasted conditions in the other treatment period. Both periods lasted 4 days, separated by a washout period of at least 35 days.
|
Total 1000 Fed
n=24 Participants
Patients were administered 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR orally in the morning under fed conditions in one treatment period and 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR orally in the morning under fed conditions in the other treatment period. Both periods lasted 4 days, separated by a washout period of at least 35 days.
|
Total 1500 Fasted
n=24 Participants
Patients were administered 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR orally in the morning under fasted conditions in one treatment period and 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR orally in the morning under fasted conditions in the other treatment period. Both periods lasted 4 days, separated by a washout period of at least 35 days.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.8 years
STANDARD_DEVIATION 9.3 • n=39 Participants
|
30.6 years
STANDARD_DEVIATION 9.0 • n=41 Participants
|
28.4 years
STANDARD_DEVIATION 7.1 • n=35 Participants
|
31.3 years
STANDARD_DEVIATION 8.8 • n=31 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
30 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
42 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment periodPopulation: Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.
Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
Outcome measures
| Measure |
FDC1000 Fasted
n=23 Participants
1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
L+M1000 Fasted
n=23 Participants
1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
FDC1000 Fed
n=21 Participants
1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
|
L+M1000 Fed
n=21 Participants
1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
|
FDC1500 Fasted
n=21 Participants
2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
L+M1500 Fasted
n=22 Participants
1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
|
|---|---|---|---|---|---|---|
|
AUC0-72 of Linagliptin
|
317.0 nmol*h/L
Geometric Coefficient of Variation 8.0
|
319.2 nmol*h/L
Geometric Coefficient of Variation 8.0
|
309.6 nmol*h/L
Geometric Coefficient of Variation 5.5
|
304.9 nmol*h/L
Geometric Coefficient of Variation 5.5
|
325.8 nmol*h/L
Geometric Coefficient of Variation 5.1
|
322.9 nmol*h/L
Geometric Coefficient of Variation 5.1
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment periodPopulation: Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.
Maximum Measured Concentration (Cmax) of Linagliptin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
Outcome measures
| Measure |
FDC1000 Fasted
n=23 Participants
1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
L+M1000 Fasted
n=23 Participants
1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
FDC1000 Fed
n=22 Participants
1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
|
L+M1000 Fed
n=22 Participants
1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
|
FDC1500 Fasted
n=21 Participants
2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
L+M1500 Fasted
n=22 Participants
1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
|
|---|---|---|---|---|---|---|
|
Cmax of Linagliptin
|
10.1 nmol/L
Geometric Coefficient of Variation 17.1
|
10.6 nmol/L
Geometric Coefficient of Variation 17.1
|
7.7 nmol/L
Geometric Coefficient of Variation 13.0
|
7.9 nmol/L
Geometric Coefficient of Variation 13.0
|
11.6 nmol/L
Geometric Coefficient of Variation 16.5
|
10.7 nmol/L
Geometric Coefficient of Variation 16.5
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment periodPopulation: Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.
Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
Outcome measures
| Measure |
FDC1000 Fasted
n=23 Participants
1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
L+M1000 Fasted
n=23 Participants
1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
FDC1000 Fed
n=22 Participants
1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
|
L+M1000 Fed
n=23 Participants
1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
|
FDC1500 Fasted
n=21 Participants
2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
L+M1500 Fasted
n=22 Participants
1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
|
|---|---|---|---|---|---|---|
|
AUC0-tz of Metformin
|
8629.0 ng*h/mL
Geometric Coefficient of Variation 21.8
|
8913.7 ng*h/mL
Geometric Coefficient of Variation 21.8
|
13772.0 ng*h/mL
Geometric Coefficient of Variation 7.4
|
13851.1 ng*h/mL
Geometric Coefficient of Variation 7.4
|
10472.9 ng*h/mL
Geometric Coefficient of Variation 18.5
|
10543.5 ng*h/mL
Geometric Coefficient of Variation 18.5
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment periodPopulation: Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.
Maximum Measured Concentration (Cmax) of Metformin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
Outcome measures
| Measure |
FDC1000 Fasted
n=23 Participants
1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
L+M1000 Fasted
n=23 Participants
1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
FDC1000 Fed
n=22 Participants
1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
|
L+M1000 Fed
n=23 Participants
1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
|
FDC1500 Fasted
n=21 Participants
2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
L+M1500 Fasted
n=22 Participants
1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
|
|---|---|---|---|---|---|---|
|
Cmax of Metformin
|
1047.4 ng/mL
Geometric Coefficient of Variation 25.5
|
1085.6 ng/mL
Geometric Coefficient of Variation 25.5
|
1119.0 ng/mL
Geometric Coefficient of Variation 8.1
|
1084.5 ng/mL
Geometric Coefficient of Variation 8.1
|
1347.0 ng/mL
Geometric Coefficient of Variation 29.3
|
1250.6 ng/mL
Geometric Coefficient of Variation 29.3
|
SECONDARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment periodPopulation: Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.
Area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 extrapolated to infinity based on predicted last concentration values. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
Outcome measures
| Measure |
FDC1000 Fasted
n=23 Participants
1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
L+M1000 Fasted
n=23 Participants
1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
FDC1000 Fed
n=22 Participants
1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
|
L+M1000 Fed
n=22 Participants
1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
|
FDC1500 Fasted
n=21 Participants
2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
L+M1500 Fasted
n=22 Participants
1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
|
|---|---|---|---|---|---|---|
|
AUC0-infinity of Linagliptin
|
546.1 nmol*h/L
Geometric Coefficient of Variation 12.8
|
526.5 nmol*h/L
Geometric Coefficient of Variation 12.8
|
537.1 nmol*h/L
Geometric Coefficient of Variation 9.6
|
510.0 nmol*h/L
Geometric Coefficient of Variation 9.6
|
562.9 nmol*h/L
Geometric Coefficient of Variation 13.5
|
581.1 nmol*h/L
Geometric Coefficient of Variation 13.5
|
SECONDARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment periodPopulation: Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.
Area under the concentration-time curve of Metformin in plasma over the time interval from 0 extrapolated to infinity based on predicted last concentration values. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
Outcome measures
| Measure |
FDC1000 Fasted
n=23 Participants
1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
L+M1000 Fasted
n=23 Participants
1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
FDC1000 Fed
n=22 Participants
1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
|
L+M1000 Fed
n=23 Participants
1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
|
FDC1500 Fasted
n=21 Participants
2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
L+M1500 Fasted
n=22 Participants
1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
|
|---|---|---|---|---|---|---|
|
AUC0-infinity of Metformin
|
9037.6 ng*h/mL
Geometric Coefficient of Variation 21.5
|
9326.5 ng*h/mL
Geometric Coefficient of Variation 21.5
|
14031.3 ng*h/mL
Geometric Coefficient of Variation 7.0
|
14069.7 ng*h/mL
Geometric Coefficient of Variation 7.0
|
11037.7 ng*h/mL
Geometric Coefficient of Variation 19.1
|
11512.2 ng*h/mL
Geometric Coefficient of Variation 19.1
|
Adverse Events
FDC1000 Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
L+M1000 Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
FDC1000 Fed
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
L+M1000 Fed
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
FDC1500 Fasted
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
L+M1500 Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FDC1000 Fasted
n=23 participants at risk
1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
L+M1000 Fasted
n=23 participants at risk
1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
FDC1000 Fed
n=22 participants at risk
1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
|
L+M1000 Fed
n=23 participants at risk
1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
|
FDC1500 Fasted
n=23 participants at risk
2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
L+M1500 Fasted
n=23 participants at risk
1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/23 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
4.3%
1/23 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
Other adverse events
| Measure |
FDC1000 Fasted
n=23 participants at risk
1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
L+M1000 Fasted
n=23 participants at risk
1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
FDC1000 Fed
n=22 participants at risk
1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
|
L+M1000 Fed
n=23 participants at risk
1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
|
FDC1500 Fasted
n=23 participants at risk
2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
|
L+M1500 Fasted
n=23 participants at risk
1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
4.3%
1/23 • 8 weeks
|
4.3%
1/23 • 8 weeks
|
4.5%
1/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
8.7%
2/23 • 8 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/23 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
8.7%
2/23 • 8 weeks
|
4.3%
1/23 • 8 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/23 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
8.7%
2/23 • 8 weeks
|
4.3%
1/23 • 8 weeks
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER