Trial Outcomes & Findings for Bioequivalence of a FDC Tablet of Linagliptin/Metformin (5mg/1000mg) Extended Release in Healthy Subjects (NCT NCT02084082)
NCT ID: NCT02084082
Last Updated: 2016-08-04
Results Overview
AUC 0-72 (area under concentration-time curve of the Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
68 participants
Primary outcome timeframe
1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration
Results posted on
2016-08-04
Participant Flow
The study is conducted in two parts: Part 1 of the study was conducted in fasting conditions. Part 2 of the study was conducted in fed conditions.
Participant milestones
| Measure |
FDC 1000 Fast/ L+M 1000 Fast
Linagliptin/Metformin Extended Release (XR) Fixed dose combination (given as 1 FDC tablet) followed by single tablets of linagliptin and metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR), oral with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin 1000mg
|
L+M1000 Fast/ FDC1000 Fast
Single tablets of linagliptin and metformin Extended Release (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) followed by Linagliptin/Metformin XR Fixed Dose Combination (given as 1 FDC tablet), oral with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin 1000mg
|
FDC1000 Fed/L+M1000 Fed
Linagliptin/Metformin XR FDC (given as 1 FDC tablet) followed by single tablets of linagliptin and metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR), oral with 240 mL of water after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin 1000mg
|
L+M1000 Fed/ FDC1000 Fed
Single tablets of linagliptin and metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) followed by Linagliptin/Metformin XR FDC (given as 1 FDC tablet), oral with 240 mL of water after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin 1000mg
|
|---|---|---|---|---|
|
Treatment Period 1 (4 Days)
STARTED
|
26
|
26
|
8
|
8
|
|
Treatment Period 1 (4 Days)
COMPLETED
|
26
|
26
|
8
|
8
|
|
Treatment Period 1 (4 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 1 (35 Days)
STARTED
|
26
|
26
|
8
|
8
|
|
Washout Period 1 (35 Days)
COMPLETED
|
26
|
26
|
7
|
6
|
|
Washout Period 1 (35 Days)
NOT COMPLETED
|
0
|
0
|
1
|
2
|
|
Treatment Period 2 (4 Days)
STARTED
|
26
|
26
|
7
|
6
|
|
Treatment Period 2 (4 Days)
COMPLETED
|
26
|
26
|
7
|
6
|
|
Treatment Period 2 (4 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
FDC 1000 Fast/ L+M 1000 Fast
Linagliptin/Metformin Extended Release (XR) Fixed dose combination (given as 1 FDC tablet) followed by single tablets of linagliptin and metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR), oral with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin 1000mg
|
L+M1000 Fast/ FDC1000 Fast
Single tablets of linagliptin and metformin Extended Release (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) followed by Linagliptin/Metformin XR Fixed Dose Combination (given as 1 FDC tablet), oral with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin 1000mg
|
FDC1000 Fed/L+M1000 Fed
Linagliptin/Metformin XR FDC (given as 1 FDC tablet) followed by single tablets of linagliptin and metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR), oral with 240 mL of water after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin 1000mg
|
L+M1000 Fed/ FDC1000 Fed
Single tablets of linagliptin and metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) followed by Linagliptin/Metformin XR FDC (given as 1 FDC tablet), oral with 240 mL of water after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin 1000mg
|
|---|---|---|---|---|
|
Washout Period 1 (35 Days)
Adverse Event
|
0
|
0
|
1
|
1
|
|
Washout Period 1 (35 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (5mg/1000mg) Extended Release in Healthy Subjects
Baseline characteristics by cohort
| Measure |
FDC 1000 Fast or L+M 1000 Fast
n=52 Participants
The subjects in Part 1 were randomly allocated to 1 of the 2 treatment sequences T fasted\_R fasted or R fasted\_T fasted.
FDC 1000 fast (T fasted): 5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
L+M 1000 fast (R fasted): 5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
Where, L+M = Linagliptin 5mg+Metformin 1000mg
|
FDC 1000 Fed or L+M 1000 Fed
n=16 Participants
The subjects in Part 2 were randomly allocated to 1 of the 2 treatment sequences T fed\_R fed or R fed\_T fed.
FDC 1000 fed (T fed): 5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
L+M 1000 fed (R fed): 5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
Where, L+M = Linagliptin 5mg+Metformin 1000mg
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.7 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
36.1 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
35.0 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administrationPopulation: PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.
AUC 0-72 (area under concentration-time curve of the Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Outcome measures
| Measure |
L+M 1000 Fasted
n=52 Participants
5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 1000 Fasted
n=52 Participants
5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 1000 Fed
n=15 Participants
5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 1000 Fed
n=14 Participants
5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)
|
286.639 nmol*h/L
Geometric Coefficient of Variation 11.8
|
287.696 nmol*h/L
Geometric Coefficient of Variation 11.8
|
234.052 nmol*h/L
Geometric Coefficient of Variation 9.2
|
221.644 nmol*h/L
Geometric Coefficient of Variation 9.2
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administrationPopulation: PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.
Cmax (maximum measured concentration of Linagliptin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Outcome measures
| Measure |
L+M 1000 Fasted
n=52 Participants
5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 1000 Fasted
n=52 Participants
5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 1000 Fed
n=15 Participants
5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 1000 Fed
n=14 Participants
5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
Maximum Measured Concentration of Linagliptin in Plasma (Cmax)
|
8.826 nmol/L
Geometric Coefficient of Variation 27.1
|
9.540 nmol/L
Geometric Coefficient of Variation 27.1
|
5.791 nmol/L
Geometric Coefficient of Variation 6.1
|
5.689 nmol/L
Geometric Coefficient of Variation 6.1
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administrationPopulation: PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.
AUC 0-t (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Outcome measures
| Measure |
L+M 1000 Fasted
n=52 Participants
5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 1000 Fasted
n=52 Participants
5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 1000 Fed
n=15 Participants
5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 1000 Fed
n=14 Participants
5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
7146.61 ng∙h/mL
Geometric Coefficient of Variation 22.2
|
7146.00 ng∙h/mL
Geometric Coefficient of Variation 22.2
|
11326.12 ng∙h/mL
Geometric Coefficient of Variation 7.1
|
10980.17 ng∙h/mL
Geometric Coefficient of Variation 7.1
|
PRIMARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administrationPopulation: PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.
Cmax (maximum measured concentration of the Metformin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Outcome measures
| Measure |
L+M 1000 Fasted
n=52 Participants
5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 1000 Fasted
n=52 Participants
5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 1000 Fed
n=15 Participants
5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 1000 Fed
n=14 Participants
5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
Cmax of Metformin in Plasma
|
925.709 ng/mL
Geometric Coefficient of Variation 23.4
|
923.543 ng/mL
Geometric Coefficient of Variation 23.4
|
947.445 ng/mL
Geometric Coefficient of Variation 5.9
|
937.685 ng/mL
Geometric Coefficient of Variation 5.9
|
SECONDARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administrationPopulation: PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.
AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Linagliptin. The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Outcome measures
| Measure |
L+M 1000 Fasted
n=52 Participants
5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 1000 Fasted
n=52 Participants
5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 1000 Fed
n=15 Participants
5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 1000 Fed
n=14 Participants
5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
|
461.306 nmol*h/L
Geometric Coefficient of Variation 14.3
|
460.009 nmol*h/L
Geometric Coefficient of Variation 14.3
|
397.945 nmol*h/L
Geometric Coefficient of Variation 32.4
|
387.424 nmol*h/L
Geometric Coefficient of Variation 32.4
|
SECONDARY outcome
Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administrationPopulation: PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.
AUC0-inf(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Metformin. The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Outcome measures
| Measure |
L+M 1000 Fasted
n=52 Participants
5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 1000 Fasted
n=52 Participants
5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 1000 Fed
n=15 Participants
5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 1000 Fed
n=13 Participants
5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
AUC0-inf of Metformin in Plasma
|
7607.75 ng∙h/mL
Geometric Coefficient of Variation 21.7
|
7540.21 ng∙h/mL
Geometric Coefficient of Variation 21.7
|
15047.37 ng∙h/mL
Geometric Coefficient of Variation 7.2
|
14773.59 ng∙h/mL
Geometric Coefficient of Variation 7.2
|
Adverse Events
L+M 1000 Fasted
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
FDC 1000 Fasted
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
L+M 1000 Fed
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
FDC 1000 Fed
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
L+M 1000 Fasted
n=52 participants at risk
5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 1000 Fasted
n=52 participants at risk
5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 1000 Fed
n=15 participants at risk
5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 1000 Fed
n=14 participants at risk
5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
6.7%
1/15 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/14 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
6.7%
1/15 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/14 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
6.7%
1/15 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/14 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
6.7%
1/15 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/14 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
6.7%
1/15 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/14 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
6.7%
1/15 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/14 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
6.7%
1/15 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/14 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
Other adverse events
| Measure |
L+M 1000 Fasted
n=52 participants at risk
5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
|
FDC 1000 Fasted
n=52 participants at risk
5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
|
L+M 1000 Fed
n=15 participants at risk
5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
|
FDC 1000 Fed
n=14 participants at risk
5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
6.7%
1/15 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/14 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
6.7%
1/15 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/14 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
1/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
7.7%
4/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/15 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
7.1%
1/14 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
|
General disorders
Fatigue
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/15 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
7.1%
1/14 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
3.8%
2/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/15 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
7.1%
1/14 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/15 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
7.1%
1/14 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
3.8%
2/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
6.7%
1/15 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/14 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
|
Nervous system disorders
Headache
|
5.8%
3/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
9.6%
5/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
13.3%
2/15 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/14 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/52 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
0.00%
0/15 • From the first drug administration for at least 7 days after the last drug administration, up to 49 days.
|
7.1%
1/14 • From the first drug administration for at least 7 days after the last drug administration, up to 49 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
- Publication restrictions are in place