Trial Outcomes & Findings for Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes (NCT NCT00622284)
NCT ID: NCT00622284
Last Updated: 2014-01-29
Results Overview
This co-primary endpoint, change from baseline, reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1560 participants
Primary outcome timeframe
Baseline and week 52
Results posted on
2014-01-29
Participant Flow
There were in total 1560 patients randomised in the study. Of these, 1 patient was not treated. The remaining 8 patients not accounted for in the treated set were removed from all study analyses (explained in trial report) due to major good-clinical-practice violations at the site, and the inability to verify the validity of any patient level data.
Participant milestones
| Measure |
Linagliptin
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
Overall Study
STARTED
|
776
|
775
|
|
Overall Study
COMPLETED
|
587
|
604
|
|
Overall Study
NOT COMPLETED
|
189
|
171
|
Reasons for withdrawal
| Measure |
Linagliptin
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
45
|
15
|
|
Overall Study
Adverse Event
|
61
|
90
|
|
Overall Study
Protocol Violation
|
12
|
5
|
|
Overall Study
Lost to Follow-up
|
11
|
13
|
|
Overall Study
Withdrawal by Subject
|
27
|
24
|
|
Overall Study
Other reason (not specified)
|
33
|
24
|
Baseline Characteristics
Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Linagliptin
n=776 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=775 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
Total
n=1551 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.8 Years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
59.8 Years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
59.8 Years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
314 Participants
n=5 Participants
|
304 Participants
n=7 Participants
|
618 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
462 Participants
n=5 Participants
|
471 Participants
n=7 Participants
|
933 Participants
n=5 Participants
|
|
Body mass index (BMI) continuous
|
30.21 kg/m^2
STANDARD_DEVIATION 4.77 • n=5 Participants
|
30.31 kg/m^2
STANDARD_DEVIATION 4.57 • n=7 Participants
|
30.26 kg/m^2
STANDARD_DEVIATION 4.67 • n=5 Participants
|
|
Weight
|
86.14 kg
STANDARD_DEVIATION 17.57 • n=5 Participants
|
86.77 kg
STANDARD_DEVIATION 16.69 • n=7 Participants
|
86.46 kg
STANDARD_DEVIATION 17.14 • n=5 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
7.69 Percent
STANDARD_DEVIATION 0.88 • n=5 Participants
|
7.69 Percent
STANDARD_DEVIATION 0.86 • n=7 Participants
|
7.69 Percent
STANDARD_DEVIATION 0.87 • n=5 Participants
|
|
Fasting blood plasma glucose (FPG)
|
164.46 mg/dL
STANDARD_DEVIATION 42.83 • n=5 Participants
|
166.09 mg/dL
STANDARD_DEVIATION 42.05 • n=7 Participants
|
165.27 mg/dL
STANDARD_DEVIATION 42.43 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 52Population: The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.
This co-primary endpoint, change from baseline, reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
Outcome measures
| Measure |
Linagliptin
n=764 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=755 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
HbA1c Change From Baseline at Week 52
|
-0.36 Percent
Standard Error 0.03
|
-0.57 Percent
Standard Error 0.03
|
PRIMARY outcome
Timeframe: Baseline and week 104Population: The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.
This co-primary endpoint, change from baseline, reflects the Week 104 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
Outcome measures
| Measure |
Linagliptin
n=764 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=755 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
HbA1c Change From Baseline at Week 104
|
-0.16 Percent
Standard Error 0.03
|
-0.36 Percent
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Baseline and week 52Population: This population includes the FAS further restricted to patients with a baseline body weight and one on-treatment body weight measurement. Last observation carried forward (LOCF) was used as imputation rule.
This key secondary endpoint, change from baseline, reflects the Week 52 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.
Outcome measures
| Measure |
Linagliptin
n=733 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=722 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
Body Weight Change From Baseline at Week 52
|
-1.12 kg
Standard Error 0.13
|
1.38 kg
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline and week 104Population: This population includes the FAS further restricted to patients with a baseline body weight and one on-treatment body weight measurement. Last observation carried forward (LOCF) was used as imputation rule.
This key secondary endpoint, change from baseline, reflects the Week 104 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.
Outcome measures
| Measure |
Linagliptin
n=733 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=722 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
Body Weight Change From Baseline at Week 104
|
-1.39 kg
Standard Error 0.16
|
1.29 kg
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Week 52Population: The treated set consisted of all patients treated with at least one dose of study drug
A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a home blood glucose monitoring (HBGM) of below 55 mg/dl (3.1 mmol/L)
Outcome measures
| Measure |
Linagliptin
n=776 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=775 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
Incidence of Hypoglycaemic Events up to 52 Weeks
|
41 Patients
|
249 Patients
|
SECONDARY outcome
Timeframe: Week 104Population: The treated set consisted of all patients treated with at least one dose of study drug
A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a HBGM of below 55 mg/dl (3.1 mmol/L)
Outcome measures
| Measure |
Linagliptin
n=776 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=775 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
Incidence of Hypoglycaemic Events up to 104 Weeks
|
58 Patients
|
280 Patients
|
SECONDARY outcome
Timeframe: Baseline and week 52Population: This population includes the FAS further restricted to patients with a baseline FPG and one on-treatment FPG measurement. Last observation carried forward (LOCF) was used as imputation rule.
This change from baseline reflects the Week 52 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and the number of previous anti-diabetic medications.
Outcome measures
| Measure |
Linagliptin
n=733 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=725 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
Fasting Plasma Glucose (FPG) Change From Baseline at Week 52
|
-8.40 mg/dL
Standard Error 1.25
|
-15.24 mg/dL
Standard Error 1.26
|
SECONDARY outcome
Timeframe: Baseline and week 104Population: This population includes the FAS further restricted to patients with a baseline FPG and one on-treatment FPG measurement. Last observation carried forward (LOCF) was used as imputation rule.
This change from baseline reflects the Week 104 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and number of previous anti-diabetic medications.
Outcome measures
| Measure |
Linagliptin
n=733 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=725 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
Fasting Plasma Glucose (FPG) Change From Baseline at Week 104
|
-2.34 mg/dL
Standard Error 1.46
|
-8.72 mg/dL
Standard Error 1.47
|
SECONDARY outcome
Timeframe: Week 52Population: Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c \>=7.0%.
The percentage of patients with an HbA1c value below 7.0% at week 52, based upon patients with baseline HbA1c \>= 7%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c \>= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.
Outcome measures
| Measure |
Linagliptin
n=592 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=599 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
Percentage of Patients With HbA1c <7.0% at Week 52
|
29.6 Percentage of patients
|
38.9 Percentage of patients
|
SECONDARY outcome
Timeframe: Week 104Population: Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c \>=7.0%.
The percentage of patients with an HbA1c value below 7.0% at week 104, based upon patients with baseline HbA1c \>= 7%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c \>= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.
Outcome measures
| Measure |
Linagliptin
n=591 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=593 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
Percentage of Patients With HbA1c <7.0% at Week 104
|
21.0 Percentage of patients
|
28.3 Percentage of patients
|
SECONDARY outcome
Timeframe: Week 52Population: Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c \>=6.5%.
The percentage of patients with an HbA1c value below 6.5% at week 52, based upon patients with baseline HbA1c \>= 6.5%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c \>= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.
Outcome measures
| Measure |
Linagliptin
n=738 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=740 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
Percentage of Patients With HbA1c <6.5% at Week 52
|
16.9 Percentage of patients
|
22.7 Percentage of patients
|
SECONDARY outcome
Timeframe: Week 104Population: Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c \>=6.5%.
The percentage of patients with an HbA1c value below 6.5% at week 104, based upon patients with baseline HbA1c \>= 6.5%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c \>= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.
Outcome measures
| Measure |
Linagliptin
n=736 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=734 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
Percentage of Patients With HbA1c <6.5% at Week 104
|
10.9 Percentage of patients
|
14.7 Percentage of patients
|
SECONDARY outcome
Timeframe: Week 104Population: FAS (NCF)
Occurrence of relative efficacy response, defined as a lowering of 0.5% HbA1c at week 104
Outcome measures
| Measure |
Linagliptin
n=764 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=755 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
Percentage of Patients With HbA1c Lowering by 0.5% at Week 104
|
26.2 Percentage of patients
|
33.5 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and week 104Population: Patients in the FAS with a valid meal tolerance test (MTT) at baseline and at least one valid on-treatment MTT (MTT104).
This change from baseline reflects the Week 104 2 hr PPG minus the Baseline 2hr PPG. Means are treatment adjusted for baseline HbA1c, baseline 2hr PPG and number of previous anti-diabetic medications.
Outcome measures
| Measure |
Linagliptin
n=212 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=222 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104
|
-28.47 mg/dL
Standard Error 4.32
|
-18.72 mg/dL
Standard Error 4.28
|
SECONDARY outcome
Timeframe: Baseline and week 4Population: The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.
Difference of base percent value \[Week x(%) - baseline (%)\]
Outcome measures
| Measure |
Linagliptin
n=764 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=755 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
HbA1c Change at Week 4
|
-0.26 Percent
Standard Deviation 0.41
|
-0.33 Percent
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: Baseline and week 8Population: The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.
Outcome measures
| Measure |
Linagliptin
n=764 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=755 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
HbA1c Change at Week 8
|
-0.37 Percent
Standard Deviation 0.59
|
-0.58 Percent
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.
Outcome measures
| Measure |
Linagliptin
n=764 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=755 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
HbA1c Change at Week 12
|
-0.43 Percent
Standard Deviation 0.64
|
-0.75 Percent
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: Baseline and week 16Population: The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.
Outcome measures
| Measure |
Linagliptin
n=764 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=755 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
HbA1c Change at Week 16
|
-0.45 Percent
Standard Deviation 0.66
|
-0.78 Percent
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: Baseline and week 28Population: The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.
Outcome measures
| Measure |
Linagliptin
n=764 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=755 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
HbA1c Change at Week 28
|
-0.43 Percent
Standard Deviation 0.73
|
-0.74 Percent
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Baseline and week 40Population: The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.
Outcome measures
| Measure |
Linagliptin
n=764 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=755 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
HbA1c Change at Week 40
|
-0.42 Percent
Standard Deviation 0.77
|
-0.69 Percent
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Baseline and week 52Population: The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.
Outcome measures
| Measure |
Linagliptin
n=764 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=755 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
HbA1c Change at Week 52
|
-0.41 Percent
Standard Deviation 0.82
|
-0.63 Percent
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: Baseline and week 65Population: The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.
Outcome measures
| Measure |
Linagliptin
n=764 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=755 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
HbA1c Change at Week 65
|
-0.32 Percent
Standard Deviation 0.91
|
-0.53 Percent
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Baseline and week 78Population: The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.
Outcome measures
| Measure |
Linagliptin
n=764 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=755 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
HbA1c Change at Week 78
|
-0.22 Percent
Standard Deviation 0.92
|
-0.43 Percent
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Baseline and week 91Population: The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.
Outcome measures
| Measure |
Linagliptin
n=764 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=755 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
HbA1c Change at Week 91
|
-0.21 Percent
Standard Deviation 0.94
|
-0.43 Percent
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Baseline and week 104Population: The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.
The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as imputation rule.
Outcome measures
| Measure |
Linagliptin
n=764 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=755 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
HbA1c Change at Week 104
|
-0.21 Percent
Standard Deviation 0.95
|
-0.41 Percent
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: Baseline and week 104Population: This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.
Outcome measures
| Measure |
Linagliptin
n=741 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=726 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
Change in Baseline Lipid Parameter Cholesterol at Week 104
|
0 mg/dL
Standard Deviation 14
|
1 mg/dL
Standard Deviation 14
|
SECONDARY outcome
Timeframe: Baseline and week 104Population: This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.
Outcome measures
| Measure |
Linagliptin
n=740 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=725 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
Change in Baseline Lipid Parameter HDL at Week 104
|
1 mg/dl
Standard Deviation 9
|
0 mg/dl
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Baseline and week 104Population: This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.
Outcome measures
| Measure |
Linagliptin
n=734 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=720 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104
|
1 mg/dL
Standard Deviation 23
|
3 mg/dL
Standard Deviation 25
|
SECONDARY outcome
Timeframe: Baseline and week 104Population: This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.
Outcome measures
| Measure |
Linagliptin
n=740 Participants
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=725 Participants
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
Change in Baseline Lipid Parameter Triglyceride at Week 104
|
-11 mg/dL
Standard Deviation 153
|
-7 mg/dL
Standard Deviation 148
|
Adverse Events
Linagliptin
Serious events: 135 serious events
Other events: 438 other events
Deaths: 0 deaths
Glimepiride
Serious events: 162 serious events
Other events: 526 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Linagliptin
n=776 participants at risk
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=775 participants at risk
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.39%
3/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Acute myocardial infarction
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.52%
4/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Angina pectoris
|
0.64%
5/776 • From day of first dose until 7 days after last dose
|
0.52%
4/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Angina unstable
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.39%
3/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Arteriospasm coronary
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Atrial fibrillation
|
0.39%
3/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Atrioventricular block
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Bradycardia
|
0.26%
2/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Cardiac failure
|
0.39%
3/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Coronary artery disease
|
0.64%
5/776 • From day of first dose until 7 days after last dose
|
0.77%
6/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Mitral valve disease mixed
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Myocardial infarction
|
0.52%
4/776 • From day of first dose until 7 days after last dose
|
0.77%
6/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Pericarditis constrictive
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Cardiac disorders
Sinoatrial block
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Congenital, familial and genetic disorders
Central nervous system dermoid tumour
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Ear and labyrinth disorders
Vertigo
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Endocrine disorders
Goitre
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Endocrine disorders
Hyperthyroidism
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Eye disorders
Cataract
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Eye disorders
Glaucoma
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Eye disorders
Optic disc haemorrhage
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Eye disorders
Optic neuropathy
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Eye disorders
Retinal degeneration
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Gastrointestinal disorders
Anal prolapse
|
0.26%
2/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Gastrointestinal disorders
Colitis
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Gastrointestinal disorders
Colonic stenosis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Gastrointestinal disorders
Diarrhoea
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Gastrointestinal disorders
Gastric polyps
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Gastrointestinal disorders
Gastritis
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.39%
3/775 • From day of first dose until 7 days after last dose
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Gastrointestinal disorders
Rectal stenosis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
General disorders
Chest pain
|
0.26%
2/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
General disorders
Drowning
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
General disorders
Fatigue
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
General disorders
Mass
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
General disorders
Medical device complication
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
General disorders
Sudden cardiac death
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Hepatobiliary disorders
Cholecystitis
|
0.26%
2/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.39%
3/776 • From day of first dose until 7 days after last dose
|
0.39%
3/775 • From day of first dose until 7 days after last dose
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Immune system disorders
Allergy to arthropod bite
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Immune system disorders
Anaphylactic reaction
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Immune system disorders
Sarcoidosis
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Abscess limb
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Appendicitis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Arthritis bacterial
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Arthritis infective
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Balanitis candida
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Bronchitis
|
0.26%
2/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Chronic sinusitis
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Cystitis
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.39%
3/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Erysipelas
|
0.26%
2/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Gangrene
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Klebsiella sepsis
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Localised infection
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Lung infection
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Malaria
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Mastitis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Otitis media chronic
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Peritonsillar abscess
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Pneumonia
|
0.64%
5/776 • From day of first dose until 7 days after last dose
|
0.52%
4/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Pyelonephritis
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Sepsis
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Sinusitis
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Skin infection
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Soft tissue infection
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.39%
3/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Urinary tract infection
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Accident
|
0.26%
2/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.26%
2/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Concussion
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Contusion
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Fall
|
0.39%
3/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Femoral nerve injury
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.26%
2/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.39%
3/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Investigations
Alanine aminotransferase increased
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Investigations
Aspartate aminotransferase increased
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Investigations
Blood alkaline phosphatase increased
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Metabolism and nutrition disorders
Dehydration
|
0.26%
2/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Metabolism and nutrition disorders
Gout
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.39%
3/775 • From day of first dose until 7 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.39%
3/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.39%
3/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.39%
3/775 • From day of first dose until 7 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.64%
5/776 • From day of first dose until 7 days after last dose
|
0.77%
6/775 • From day of first dose until 7 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign muscle neoplasm
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.39%
3/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.26%
2/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal cavity
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.26%
2/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pleura
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic bronchial carcinoma
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteoma
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer recurrent
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.77%
6/776 • From day of first dose until 7 days after last dose
|
0.39%
3/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Agnosia
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Amnesia
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Carotid artery stenosis
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.52%
4/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Cerebral ischaemia
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Cerebrovascular accident
|
0.26%
2/776 • From day of first dose until 7 days after last dose
|
0.77%
6/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Dizziness
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Hypoaesthesia
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Ischaemic stroke
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Parkinson's disease
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Sciatica
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Syncope
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Transient ischaemic attack
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.65%
5/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Psychiatric disorders
Confusional state
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Psychiatric disorders
Delirium tremens
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Psychiatric disorders
Depression
|
0.26%
2/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Psychiatric disorders
Paranoia
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Renal and urinary disorders
Haematuria
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Renal and urinary disorders
Hydronephrosis
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.26%
2/776 • From day of first dose until 7 days after last dose
|
0.39%
3/775 • From day of first dose until 7 days after last dose
|
|
Renal and urinary disorders
Renal colic
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.52%
4/775 • From day of first dose until 7 days after last dose
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Renal and urinary disorders
Renal failure acute
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Renal and urinary disorders
Urinary incontinence
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Reproductive system and breast disorders
Cystocele
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Reproductive system and breast disorders
Penile curvature
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.26%
2/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Reproductive system and breast disorders
Prostatism
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Reproductive system and breast disorders
Urogenital prolapse
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Reproductive system and breast disorders
Vaginal cyst
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.39%
3/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Skin and subcutaneous tissue disorders
Hypertrophic scar
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Vascular disorders
Aortic aneurysm
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Vascular disorders
Arterial occlusive disease
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Vascular disorders
Arterial stenosis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Vascular disorders
Deep vein thrombosis
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
|
Vascular disorders
Hypotension
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.26%
2/776 • From day of first dose until 7 days after last dose
|
0.26%
2/775 • From day of first dose until 7 days after last dose
|
|
Vascular disorders
Peripheral embolism
|
0.13%
1/776 • From day of first dose until 7 days after last dose
|
0.00%
0/775 • From day of first dose until 7 days after last dose
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/776 • From day of first dose until 7 days after last dose
|
0.13%
1/775 • From day of first dose until 7 days after last dose
|
Other adverse events
| Measure |
Linagliptin
n=776 participants at risk
Patients randomized to receive Linagliptin 5mg and metformin
|
Glimepiride
n=775 participants at risk
Patients randomized to receive Glimepiride 1-4mg and metformin
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
52/776 • From day of first dose until 7 days after last dose
|
7.7%
60/775 • From day of first dose until 7 days after last dose
|
|
Gastrointestinal disorders
Nausea
|
4.8%
37/776 • From day of first dose until 7 days after last dose
|
5.0%
39/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Bronchitis
|
6.4%
50/776 • From day of first dose until 7 days after last dose
|
7.7%
60/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Nasopharyngitis
|
16.0%
124/776 • From day of first dose until 7 days after last dose
|
16.1%
125/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
62/776 • From day of first dose until 7 days after last dose
|
7.6%
59/775 • From day of first dose until 7 days after last dose
|
|
Infections and infestations
Urinary tract infection
|
6.3%
49/776 • From day of first dose until 7 days after last dose
|
6.6%
51/775 • From day of first dose until 7 days after last dose
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.0%
39/776 • From day of first dose until 7 days after last dose
|
5.2%
40/775 • From day of first dose until 7 days after last dose
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
7.1%
55/776 • From day of first dose until 7 days after last dose
|
34.5%
267/775 • From day of first dose until 7 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
60/776 • From day of first dose until 7 days after last dose
|
5.8%
45/775 • From day of first dose until 7 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.8%
68/776 • From day of first dose until 7 days after last dose
|
8.4%
65/775 • From day of first dose until 7 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
41/776 • From day of first dose until 7 days after last dose
|
3.9%
30/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Dizziness
|
3.4%
26/776 • From day of first dose until 7 days after last dose
|
6.1%
47/775 • From day of first dose until 7 days after last dose
|
|
Nervous system disorders
Headache
|
6.4%
50/776 • From day of first dose until 7 days after last dose
|
5.2%
40/775 • From day of first dose until 7 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
47/776 • From day of first dose until 7 days after last dose
|
4.9%
38/775 • From day of first dose until 7 days after last dose
|
|
Vascular disorders
Hypertension
|
6.2%
48/776 • From day of first dose until 7 days after last dose
|
7.7%
60/775 • From day of first dose until 7 days after last dose
|
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