Trial Outcomes & Findings for Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design (NCT NCT00798161)
NCT ID: NCT00798161
Last Updated: 2014-01-28
Results Overview
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
857 participants
Primary outcome timeframe
Baseline and week 24
Results posted on
2014-01-28
Participant Flow
Participant milestones
| Measure |
Placebo
Patients treated with matching placebo
|
M500 Twice Daily (BID)
Patients treated with Metformin 500 mg BID
|
M1000 BID
Patients treated with Metformin 1000 mg BID
|
Lina 5
Patients treated with Linagliptin 5 mg once daily (OD)
|
L2.5+M500 BID
Patients treated with Linagliptin 2.5 mg + Metformin 500 mg BID
|
L2.5 + M1000 BID
Patients treated with Linagliptin 2.5 mg + Metformin 1000 mg BID
|
OL: L2.5+M1000 BID
Open label set: Linagliptin 2.5 mg + Metformin 1000 mg BID
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
72
|
144
|
147
|
142
|
143
|
143
|
66
|
|
Overall Study
COMPLETED
|
54
|
127
|
126
|
121
|
127
|
132
|
56
|
|
Overall Study
NOT COMPLETED
|
18
|
17
|
21
|
21
|
16
|
11
|
10
|
Reasons for withdrawal
| Measure |
Placebo
Patients treated with matching placebo
|
M500 Twice Daily (BID)
Patients treated with Metformin 500 mg BID
|
M1000 BID
Patients treated with Metformin 1000 mg BID
|
Lina 5
Patients treated with Linagliptin 5 mg once daily (OD)
|
L2.5+M500 BID
Patients treated with Linagliptin 2.5 mg + Metformin 500 mg BID
|
L2.5 + M1000 BID
Patients treated with Linagliptin 2.5 mg + Metformin 1000 mg BID
|
OL: L2.5+M1000 BID
Open label set: Linagliptin 2.5 mg + Metformin 1000 mg BID
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
4
|
6
|
6
|
5
|
2
|
4
|
|
Overall Study
Protocol Violation
|
2
|
1
|
3
|
3
|
3
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
4
|
3
|
4
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
5
|
4
|
2
|
3
|
1
|
|
Overall Study
Other reason (incl. lack of efficacy)
|
7
|
5
|
3
|
5
|
2
|
4
|
5
|
Baseline Characteristics
Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design
Baseline characteristics by cohort
| Measure |
Placebo
n=72 Participants
Patients treated with matching placebo
|
M500BID
n=144 Participants
Patients treated with Metformin 500mg BID
|
M1000BID
n=147 Participants
Patients treated with Metformin 1000mg BID
|
Lina5
n=142 Participants
Patients treated with Linagliptin 5mg OD
|
L2.5+M500BID
n=143 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
|
L2.5+M1000BID
n=143 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
|
L2.5+M1000BID (Open Label)
n=66 Participants
Open label set: Linagliptin 2.5mg + Metformin 1000mg BID
|
Total
n=857 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.7 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
52.9 Years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
55.2 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
56.2 Years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
55.6 Years
STANDARD_DEVIATION 11.2 • n=21 Participants
|
56.4 Years
STANDARD_DEVIATION 10.7 • n=10 Participants
|
53.5 Years
STANDARD_DEVIATION 11.1 • n=115 Participants
|
55.2 Years
STANDARD_DEVIATION 10.8 • n=6 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
66 Participants
n=10 Participants
|
40 Participants
n=115 Participants
|
405 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
77 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
452 Participants
n=6 Participants
|
|
Body Mass Index (BMI) continuous
|
28.62 kg/m^2
STANDARD_DEVIATION 5.17 • n=5 Participants
|
28.92 kg/m^2
STANDARD_DEVIATION 4.83 • n=7 Participants
|
29.52 kg/m^2
STANDARD_DEVIATION 5.31 • n=5 Participants
|
28.95 kg/m^2
STANDARD_DEVIATION 4.67 • n=4 Participants
|
29.66 kg/m^2
STANDARD_DEVIATION 5.31 • n=21 Participants
|
28.55 kg/m^2
STANDARD_DEVIATION 4.80 • n=10 Participants
|
28.81 kg/m^2
STANDARD_DEVIATION 4.93 • n=115 Participants
|
29.07 kg/m^2
STANDARD_DEVIATION 4.97 • n=6 Participants
|
|
Glycosylated Hemoglobin A1 (HbA1C)
|
8.67 Percent
STANDARD_DEVIATION 0.95 • n=5 Participants
|
8.66 Percent
STANDARD_DEVIATION 0.90 • n=7 Participants
|
8.52 Percent
STANDARD_DEVIATION 0.87 • n=5 Participants
|
8.70 Percent
STANDARD_DEVIATION 0.97 • n=4 Participants
|
8.71 Percent
STANDARD_DEVIATION 0.95 • n=21 Participants
|
8.68 Percent
STANDARD_DEVIATION 1.03 • n=10 Participants
|
11.84 Percent
STANDARD_DEVIATION 1.42 • n=115 Participants
|
8.91 Percent
STANDARD_DEVIATION 1.31 • n=6 Participants
|
|
Fasting plasma glucose (FPG)
|
203.7 mg/dL
STANDARD_DEVIATION 51.2 • n=5 Participants
|
191.2 mg/dL
STANDARD_DEVIATION 46.9 • n=7 Participants
|
192.3 mg/dL
STANDARD_DEVIATION 52.8 • n=5 Participants
|
195.3 mg/dL
STANDARD_DEVIATION 50.2 • n=4 Participants
|
198.6 mg/dL
STANDARD_DEVIATION 60.2 • n=21 Participants
|
196.9 mg/dL
STANDARD_DEVIATION 51.2 • n=10 Participants
|
261.8 mg/dL
STANDARD_DEVIATION 80.9 • n=115 Participants
|
200.2 mg/dL
STANDARD_DEVIATION 57.3 • n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 24Population: The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Outcome measures
| Measure |
L2.5+M1000BID
n=140 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
|
Placebo
n=65 Participants
Patients treated with matching placebo
|
M500BID
n=141 Participants
Patients treated with Metformin 500mg BID
|
M1000BID
n=138 Participants
Patients treated with Metformin 1000mg BID
|
Lina5
n=135 Participants
Patients treated with Linagliptin 5mg OD
|
L2.5+M500BID
n=137 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
|
|---|---|---|---|---|---|---|
|
HbA1c Change From Baseline at Week 24
|
-1.59 Percent
Standard Error 0.08
|
0.13 Percent
Standard Error 0.11
|
-0.64 Percent
Standard Error 0.08
|
-1.07 Percent
Standard Error 0.08
|
-0.45 Percent
Standard Error 0.08
|
-1.22 Percent
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline and week 6Population: The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Outcome measures
| Measure |
L2.5+M1000BID
n=140 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
|
Placebo
n=65 Participants
Patients treated with matching placebo
|
M500BID
n=141 Participants
Patients treated with Metformin 500mg BID
|
M1000BID
n=138 Participants
Patients treated with Metformin 1000mg BID
|
Lina5
n=135 Participants
Patients treated with Linagliptin 5mg OD
|
L2.5+M500BID
n=137 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
|
|---|---|---|---|---|---|---|
|
HbA1c Change From Baseline at Week 6
|
-1.00 Percent
Standard Error 0.05
|
0.03 Percent
Standard Error 0.08
|
-0.45 Percent
Standard Error 0.05
|
-0.61 Percent
Standard Error 0.05
|
-0.36 Percent
Standard Error 0.06
|
-0.86 Percent
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Outcome measures
| Measure |
L2.5+M1000BID
n=140 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
|
Placebo
n=65 Participants
Patients treated with matching placebo
|
M500BID
n=141 Participants
Patients treated with Metformin 500mg BID
|
M1000BID
n=138 Participants
Patients treated with Metformin 1000mg BID
|
Lina5
n=135 Participants
Patients treated with Linagliptin 5mg OD
|
L2.5+M500BID
n=137 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
|
|---|---|---|---|---|---|---|
|
HbA1c Change From Baseline at Week 12
|
-1.37 Percent
Standard Error 0.07
|
0.16 Percent
Standard Error 0.11
|
-0.61 Percent
Standard Error 0.07
|
-0.95 Percent
Standard Error 0.07
|
-0.42 Percent
Standard Error 0.07
|
-1.13 Percent
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline and week 18Population: The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Outcome measures
| Measure |
L2.5+M1000BID
n=140 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
|
Placebo
n=65 Participants
Patients treated with matching placebo
|
M500BID
n=141 Participants
Patients treated with Metformin 500mg BID
|
M1000BID
n=138 Participants
Patients treated with Metformin 1000mg BID
|
Lina5
n=135 Participants
Patients treated with Linagliptin 5mg OD
|
L2.5+M500BID
n=137 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
|
|---|---|---|---|---|---|---|
|
HbA1c Change From Baseline at Week 18
|
-1.54 Percent
Standard Error 0.08
|
0.16 Percent
Standard Error 0.12
|
-0.66 Percent
Standard Error 0.08
|
-1.06 Percent
Standard Error 0.08
|
-0.45 Percent
Standard Error 0.08
|
-1.17 Percent
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline and week 24Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Outcome measures
| Measure |
L2.5+M1000BID
n=136 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
|
Placebo
n=61 Participants
Patients treated with matching placebo
|
M500BID
n=136 Participants
Patients treated with Metformin 500mg BID
|
M1000BID
n=132 Participants
Patients treated with Metformin 1000mg BID
|
Lina5
n=134 Participants
Patients treated with Linagliptin 5mg OD
|
L2.5+M500BID
n=135 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
|
|---|---|---|---|---|---|---|
|
FPG Change From Baseline at Week 24
|
-49.4 mg/dL
Standard Error 3.5
|
10.2 mg/dL
Standard Error 5.3
|
-15.8 mg/dL
Standard Error 3.5
|
-32.2 mg/dL
Standard Error 3.6
|
-8.6 mg/dL
Standard Error 3.6
|
-33.2 mg/dL
Standard Error 3.5
|
SECONDARY outcome
Timeframe: Baseline and week 2Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
This change from baseline reflects the Week 2 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Outcome measures
| Measure |
L2.5+M1000BID
n=136 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
|
Placebo
n=61 Participants
Patients treated with matching placebo
|
M500BID
n=136 Participants
Patients treated with Metformin 500mg BID
|
M1000BID
n=132 Participants
Patients treated with Metformin 1000mg BID
|
Lina5
n=134 Participants
Patients treated with Linagliptin 5mg OD
|
L2.5+M500BID
n=135 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
|
|---|---|---|---|---|---|---|
|
FPG Change From Baseline at Week 2
|
-38.6 mg/dL
Standard Error 2.9
|
5.3 mg/dL
Standard Error 4.3
|
-19.6 mg/dL
Standard Error 2.9
|
-21.8 mg/dL
Standard Error 2.9
|
-13.0 mg/dL
Standard Error 2.9
|
-34.5 mg/dL
Standard Error 2.9
|
SECONDARY outcome
Timeframe: Baseline and week 6Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Outcome measures
| Measure |
L2.5+M1000BID
n=136 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
|
Placebo
n=61 Participants
Patients treated with matching placebo
|
M500BID
n=136 Participants
Patients treated with Metformin 500mg BID
|
M1000BID
n=132 Participants
Patients treated with Metformin 1000mg BID
|
Lina5
n=134 Participants
Patients treated with Linagliptin 5mg OD
|
L2.5+M500BID
n=135 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
|
|---|---|---|---|---|---|---|
|
FPG Change From Baseline at Week 6
|
-48.3 mg/dL
Standard Error 3.2
|
6.2 mg/dL
Standard Error 4.7
|
-20.8 mg/dL
Standard Error 3.2
|
-31.6 mg/dL
Standard Error 3.2
|
-10.8 mg/dL
Standard Error 3.2
|
-38.7 mg/dL
Standard Error 3.2
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Outcome measures
| Measure |
L2.5+M1000BID
n=136 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
|
Placebo
n=61 Participants
Patients treated with matching placebo
|
M500BID
n=136 Participants
Patients treated with Metformin 500mg BID
|
M1000BID
n=132 Participants
Patients treated with Metformin 1000mg BID
|
Lina5
n=134 Participants
Patients treated with Linagliptin 5mg OD
|
L2.5+M500BID
n=135 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
|
|---|---|---|---|---|---|---|
|
FPG Change From Baseline at Week 12
|
-49.9 mg/dL
Standard Error 3.3
|
8.9 mg/dL
Standard Error 5.0
|
-21.8 mg/dL
Standard Error 3.3
|
-31.9 mg/dL
Standard Error 3.4
|
-8.4 mg/dL
Standard Error 3.4
|
-36.2 mg/dL
Standard Error 3.4
|
SECONDARY outcome
Timeframe: Baseline and week 18Population: This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Outcome measures
| Measure |
L2.5+M1000BID
n=136 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
|
Placebo
n=61 Participants
Patients treated with matching placebo
|
M500BID
n=136 Participants
Patients treated with Metformin 500mg BID
|
M1000BID
n=132 Participants
Patients treated with Metformin 1000mg BID
|
Lina5
n=134 Participants
Patients treated with Linagliptin 5mg OD
|
L2.5+M500BID
n=135 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
|
|---|---|---|---|---|---|---|
|
FPG Change From Baseline at Week 18
|
-48.1 mg/dL
Standard Error 3.4
|
7.3 mg/dL
Standard Error 5.1
|
-13.7 mg/dL
Standard Error 3.4
|
-30.3 mg/dL
Standard Error 3.5
|
-9.2 mg/dL
Standard Error 3.4
|
-34.6 mg/dL
Standard Error 3.4
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS treated and randomised patients with baseline HbA1c \>= 7.0%. Non-completers were considered as failure imputation (NCF).
The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.
Outcome measures
| Measure |
L2.5+M1000BID
n=138 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
|
Placebo
n=65 Participants
Patients treated with matching placebo
|
M500BID
n=140 Participants
Patients treated with Metformin 500mg BID
|
M1000BID
n=137 Participants
Patients treated with Metformin 1000mg BID
|
Lina5
n=135 Participants
Patients treated with Linagliptin 5mg OD
|
L2.5+M500BID
n=136 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With HbA1c <7.0% at Week 24
|
53.6 percentage of patients
0
|
10.8 percentage of patients
0
|
18.6 percentage of patients
0
|
30.7 percentage of patients
0
|
10.4 percentage of patients
0
|
30.1 percentage of patients
0
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The FAS included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).
The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.
Outcome measures
| Measure |
L2.5+M1000BID
n=140 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
|
Placebo
n=65 Participants
Patients treated with matching placebo
|
M500BID
n=141 Participants
Patients treated with Metformin 500mg BID
|
M1000BID
n=138 Participants
Patients treated with Metformin 1000mg BID
|
Lina5
n=135 Participants
Patients treated with Linagliptin 5mg OD
|
L2.5+M500BID
n=137 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With HbA1c<7.0 at Week 24
|
54.3 percentage of patients
|
10.8 percentage of patients
|
19.1 percentage of patients
|
31.2 percentage of patients
|
10.4 percentage of patients
|
30.7 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: FAS treated and randomised patients with baseline HbA1c \>= 6.5%. Non-completers were considered as failure imputation (NCF).
The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c =\< 6.5%
Outcome measures
| Measure |
L2.5+M1000BID
n=140 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
|
Placebo
n=65 Participants
Patients treated with matching placebo
|
M500BID
n=141 Participants
Patients treated with Metformin 500mg BID
|
M1000BID
n=138 Participants
Patients treated with Metformin 1000mg BID
|
Lina5
n=135 Participants
Patients treated with Linagliptin 5mg OD
|
L2.5+M500BID
n=137 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With HbA1c <6.5% at Week 24
|
27.1 percentage of patients
0
|
3.1 percentage of patients
0
|
5.0 percentage of patients
0
|
12.3 percentage of patients
0
|
3.7 percentage of patients
0
|
13.1 percentage of patients
0
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The FAS included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).
The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%
Outcome measures
| Measure |
L2.5+M1000BID
n=140 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
|
Placebo
n=65 Participants
Patients treated with matching placebo
|
M500BID
n=141 Participants
Patients treated with Metformin 500mg BID
|
M1000BID
n=138 Participants
Patients treated with Metformin 1000mg BID
|
Lina5
n=135 Participants
Patients treated with Linagliptin 5mg OD
|
L2.5+M500BID
n=137 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With HbA1c < 6.5% at Week 24
|
27.1 percentage of patients
|
3.1 percentage of patients
|
5.0 percentage of patients
|
12.3 percentage of patients
|
3.7 percentage of patients
|
13.1 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and week 24Population: The FAS included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).
The percentage of patients with an HbA1c reduction from baseline greater than 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.
Outcome measures
| Measure |
L2.5+M1000BID
n=140 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
|
Placebo
n=65 Participants
Patients treated with matching placebo
|
M500BID
n=141 Participants
Patients treated with Metformin 500mg BID
|
M1000BID
n=138 Participants
Patients treated with Metformin 1000mg BID
|
Lina5
n=135 Participants
Patients treated with Linagliptin 5mg OD
|
L2.5+M500BID
n=137 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With HbA1c Lowering by 0.5% at Week 24
|
81.4 percentage of patients
0
|
29.2 percentage of patients
0
|
46.1 percentage of patients
0
|
65.9 percentage of patients
0
|
42.2 percentage of patients
0
|
71.5 percentage of patients
0
|
SECONDARY outcome
Timeframe: Baseline and week 24Population: Meal tolerance test (MTT) set (patients with adequate MTT results available at the beginning and end of the randomised treatment period)
This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline 2h PPG and previous anti-diabetic medication.
Outcome measures
| Measure |
L2.5+M1000BID
n=12 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
|
Placebo
n=6 Participants
Patients treated with matching placebo
|
M500BID
n=15 Participants
Patients treated with Metformin 500mg BID
|
M1000BID
n=14 Participants
Patients treated with Metformin 1000mg BID
|
Lina5
n=12 Participants
Patients treated with Linagliptin 5mg OD
|
L2.5+M500BID
n=10 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
|
|---|---|---|---|---|---|---|
|
Adjusted Means for 2h Post-Prandial Glucose (PPG) Change From Baseline at Week 24
|
-109.2 mg/dL
Standard Error 16.2
|
-35.4 mg/dL
Standard Error 23.2
|
-82.9 mg/dL
Standard Error 14.4
|
-87.2 mg/dL
Standard Error 14.8
|
-35.3 mg/dL
Standard Error 16.1
|
-86.0 mg/dL
Standard Error 17.5
|
SECONDARY outcome
Timeframe: Baseline and week 24Population: The open label set (OLS) included all patients with baseline HbA1c too high to be randomised and were assigned open-label medication, also with an on treatment HbA1c value. The Open label Set (OLS) included all patients treated with at least one dose on open-label L2.5+M1000 medication.
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percentage. Mean is unadjusted.
Outcome measures
| Measure |
L2.5+M1000BID
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
|
Placebo
n=65 Participants
Patients treated with matching placebo
|
M500BID
Patients treated with Metformin 500mg BID
|
M1000BID
Patients treated with Metformin 1000mg BID
|
Lina5
Patients treated with Linagliptin 5mg OD
|
L2.5+M500BID
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
|
|---|---|---|---|---|---|---|
|
HbA1c Change From Baseline at Week 24 for Open-label Patients
|
—
|
-3.19 Percent
Standard Deviation 2.04
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and week 24Population: The open label set (OLS) included all patients with baseline HbA1c too high to be randomised and were assigned open-label medication, also with a baseline on treatment HbA1c value. The Open label Set (OLS) included all patients treated with at least one dose on open-label L2.5+M1000 medication.
This change from baseline reflects the Week 24 FPG minus the baseline FPG. Mean is unadjusted.
Outcome measures
| Measure |
L2.5+M1000BID
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
|
Placebo
n=55 Participants
Patients treated with matching placebo
|
M500BID
Patients treated with Metformin 500mg BID
|
M1000BID
Patients treated with Metformin 1000mg BID
|
Lina5
Patients treated with Linagliptin 5mg OD
|
L2.5+M500BID
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
|
|---|---|---|---|---|---|---|
|
FPG Change From Baseline at Week 24 for Open-label Patients
|
—
|
-73.58 mg/dL
Standard Deviation 70.94
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Percentage of patients requiring rescue therapy
The use of rescue therapy (SUs, thiazolidinediones \[TZDs\], or insulin) was permitted only during the randomised treatment period of the trial (i.e. Visits 3 to 7), and was to be administered only if a patient had a 'confirmed' glucose level after an overnight fast.
Outcome measures
| Measure |
L2.5+M1000BID
n=140 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
|
Placebo
n=65 Participants
Patients treated with matching placebo
|
M500BID
n=141 Participants
Patients treated with Metformin 500mg BID
|
M1000BID
n=138 Participants
Patients treated with Metformin 1000mg BID
|
Lina5
n=135 Participants
Patients treated with Linagliptin 5mg OD
|
L2.5+M500BID
n=137 Participants
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
|
|---|---|---|---|---|---|---|
|
Use of Rescue Therapy
|
4.3 percentage of participants
|
29.2 percentage of participants
|
13.5 percentage of participants
|
8.0 percentage of participants
|
11.1 percentage of participants
|
7.3 percentage of participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
M500 BID
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
M1000 BID
Serious events: 6 serious events
Other events: 27 other events
Deaths: 0 deaths
Lina 5
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
L2.5+M500 BID
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
L2.5 + M1000 BID
Serious events: 2 serious events
Other events: 36 other events
Deaths: 0 deaths
OL: L2.5+M1000 BID
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=72 participants at risk
Patients treated with matching placebo
|
M500 BID
n=144 participants at risk
Patients treated with Metformin 500 mg BID
|
M1000 BID
n=147 participants at risk
Patients treated with Metformin 1000 mg bis in die (BID)
|
Lina 5
n=142 participants at risk
Patients treated with Linagliptin 5 mg once daily (OD)
|
L2.5+M500 BID
n=143 participants at risk
Patients treated with Linagliptin 2.5 mg + Metformin 500 mg bis in die (BID)
|
L2.5 + M1000 BID
n=143 participants at risk
Patients treated with Linagliptin 2.5 mg + Metformin 1000 mg bis in die (BID)
|
OL: L2.5+M1000 BID
n=66 participants at risk
Open label set: Linagliptin 2.5 mg + Metformin 1000 mg bis in die (BID)
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.69%
1/144 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/147 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/144 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/147 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.70%
1/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/144 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/147 • Day of first dose until day of last dose plus 7 days
|
0.70%
1/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Cardiac disorders
Bradycardia
|
1.4%
1/72 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/144 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/147 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/144 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/147 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.70%
1/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/144 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/147 • Day of first dose until day of last dose plus 7 days
|
0.70%
1/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/144 • Day of first dose until day of last dose plus 7 days
|
0.68%
1/147 • Day of first dose until day of last dose plus 7 days
|
0.70%
1/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/144 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/147 • Day of first dose until day of last dose plus 7 days
|
0.70%
1/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.70%
1/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/144 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/147 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/142 • Day of first dose until day of last dose plus 7 days
|
0.70%
1/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/144 • Day of first dose until day of last dose plus 7 days
|
0.68%
1/147 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Infections and infestations
Erysipelas
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/144 • Day of first dose until day of last dose plus 7 days
|
0.68%
1/147 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Infections and infestations
Malaria
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.69%
1/144 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/147 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Infections and infestations
Plasmodium falciparum infection
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.69%
1/144 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/147 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.69%
1/144 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/147 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/144 • Day of first dose until day of last dose plus 7 days
|
0.68%
1/147 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/144 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/147 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/142 • Day of first dose until day of last dose plus 7 days
|
0.70%
1/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.69%
1/144 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/147 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/144 • Day of first dose until day of last dose plus 7 days
|
0.68%
1/147 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.69%
1/144 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/147 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage III
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/144 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/147 • Day of first dose until day of last dose plus 7 days
|
0.70%
1/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/144 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/147 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.70%
1/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.69%
1/144 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/147 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/144 • Day of first dose until day of last dose plus 7 days
|
0.68%
1/147 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/144 • Day of first dose until day of last dose plus 7 days
|
0.68%
1/147 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/144 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/147 • Day of first dose until day of last dose plus 7 days
|
0.70%
1/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/66 • Day of first dose until day of last dose plus 7 days
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/72 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/144 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/147 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/142 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/143 • Day of first dose until day of last dose plus 7 days
|
1.5%
1/66 • Day of first dose until day of last dose plus 7 days
|
Other adverse events
| Measure |
Placebo
n=72 participants at risk
Patients treated with matching placebo
|
M500 BID
n=144 participants at risk
Patients treated with Metformin 500 mg BID
|
M1000 BID
n=147 participants at risk
Patients treated with Metformin 1000 mg bis in die (BID)
|
Lina 5
n=142 participants at risk
Patients treated with Linagliptin 5 mg once daily (OD)
|
L2.5+M500 BID
n=143 participants at risk
Patients treated with Linagliptin 2.5 mg + Metformin 500 mg bis in die (BID)
|
L2.5 + M1000 BID
n=143 participants at risk
Patients treated with Linagliptin 2.5 mg + Metformin 1000 mg bis in die (BID)
|
OL: L2.5+M1000 BID
n=66 participants at risk
Open label set: Linagliptin 2.5 mg + Metformin 1000 mg bis in die (BID)
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
2/72 • Day of first dose until day of last dose plus 7 days
|
2.1%
3/144 • Day of first dose until day of last dose plus 7 days
|
5.4%
8/147 • Day of first dose until day of last dose plus 7 days
|
3.5%
5/142 • Day of first dose until day of last dose plus 7 days
|
4.9%
7/143 • Day of first dose until day of last dose plus 7 days
|
7.7%
11/143 • Day of first dose until day of last dose plus 7 days
|
6.1%
4/66 • Day of first dose until day of last dose plus 7 days
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
1/72 • Day of first dose until day of last dose plus 7 days
|
2.8%
4/144 • Day of first dose until day of last dose plus 7 days
|
2.7%
4/147 • Day of first dose until day of last dose plus 7 days
|
5.6%
8/142 • Day of first dose until day of last dose plus 7 days
|
8.4%
12/143 • Day of first dose until day of last dose plus 7 days
|
4.2%
6/143 • Day of first dose until day of last dose plus 7 days
|
3.0%
2/66 • Day of first dose until day of last dose plus 7 days
|
|
Investigations
Glomerular filtration rate decreased
|
5.6%
4/72 • Day of first dose until day of last dose plus 7 days
|
2.8%
4/144 • Day of first dose until day of last dose plus 7 days
|
2.0%
3/147 • Day of first dose until day of last dose plus 7 days
|
3.5%
5/142 • Day of first dose until day of last dose plus 7 days
|
1.4%
2/143 • Day of first dose until day of last dose plus 7 days
|
4.2%
6/143 • Day of first dose until day of last dose plus 7 days
|
1.5%
1/66 • Day of first dose until day of last dose plus 7 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.9%
10/72 • Day of first dose until day of last dose plus 7 days
|
7.6%
11/144 • Day of first dose until day of last dose plus 7 days
|
2.0%
3/147 • Day of first dose until day of last dose plus 7 days
|
3.5%
5/142 • Day of first dose until day of last dose plus 7 days
|
3.5%
5/143 • Day of first dose until day of last dose plus 7 days
|
1.4%
2/143 • Day of first dose until day of last dose plus 7 days
|
10.6%
7/66 • Day of first dose until day of last dose plus 7 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
2/72 • Day of first dose until day of last dose plus 7 days
|
0.00%
0/144 • Day of first dose until day of last dose plus 7 days
|
3.4%
5/147 • Day of first dose until day of last dose plus 7 days
|
3.5%
5/142 • Day of first dose until day of last dose plus 7 days
|
1.4%
2/143 • Day of first dose until day of last dose plus 7 days
|
5.6%
8/143 • Day of first dose until day of last dose plus 7 days
|
3.0%
2/66 • Day of first dose until day of last dose plus 7 days
|
|
Vascular disorders
Hypertension
|
5.6%
4/72 • Day of first dose until day of last dose plus 7 days
|
3.5%
5/144 • Day of first dose until day of last dose plus 7 days
|
2.7%
4/147 • Day of first dose until day of last dose plus 7 days
|
2.1%
3/142 • Day of first dose until day of last dose plus 7 days
|
3.5%
5/143 • Day of first dose until day of last dose plus 7 days
|
3.5%
5/143 • Day of first dose until day of last dose plus 7 days
|
4.5%
3/66 • Day of first dose until day of last dose plus 7 days
|
|
Infections and infestations
Urinary tract infection
|
2.8%
2/72 • Day of first dose until day of last dose plus 7 days
|
2.1%
3/144 • Day of first dose until day of last dose plus 7 days
|
2.0%
3/147 • Day of first dose until day of last dose plus 7 days
|
1.4%
2/142 • Day of first dose until day of last dose plus 7 days
|
1.4%
2/143 • Day of first dose until day of last dose plus 7 days
|
4.9%
7/143 • Day of first dose until day of last dose plus 7 days
|
6.1%
4/66 • Day of first dose until day of last dose plus 7 days
|
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