Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00798161
Recruitment Status : Completed
First Posted : November 25, 2008
Results First Posted : August 4, 2011
Last Update Posted : January 28, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: BI 1356
Drug: BI 1356 + metformin
Drug: Bi 1356 + metformin
Drug: Metformin
Drug: metformin
Drug: matching placebo
Enrollment 857
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo M500 Twice Daily (BID) M1000 BID Lina 5 L2.5+M500 BID L2.5 + M1000 BID OL: L2.5+M1000 BID
Hide Arm/Group Description Patients treated with matching placebo Patients treated with Metformin 500 mg BID Patients treated with Metformin 1000 mg BID Patients treated with Linagliptin 5 mg once daily (OD) Patients treated with Linagliptin 2.5 mg + Metformin 500 mg BID Patients treated with Linagliptin 2.5 mg + Metformin 1000 mg BID Open label set: Linagliptin 2.5 mg + Metformin 1000 mg BID
Period Title: Overall Study
Started 72 144 147 142 143 143 66
Completed 54 127 126 121 127 132 56
Not Completed 18 17 21 21 16 11 10
Reason Not Completed
Adverse Event             3             4             6             6             5             2             4
Protocol Violation             2             1             3             3             3             2             0
Lost to Follow-up             1             3             4             3             4             0             0
Withdrawal by Subject             5             4             5             4             2             3             1
Other reason (incl. lack of efficacy)             7             5             3             5             2             4             5
Arm/Group Title Placebo M500BID M1000BID Lina5 L2.5+M500BID L2.5+M1000BID L2.5+M1000BID (Open Label) Total
Hide Arm/Group Description Patients treated with matching placebo Patients treated with Metformin 500mg BID Patients treated with Metformin 1000mg BID Patients treated with Linagliptin 5mg OD Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID Open label set: Linagliptin 2.5mg + Metformin 1000mg BID Total of all reporting groups
Overall Number of Baseline Participants 72 144 147 142 143 143 66 857
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 144 participants 147 participants 142 participants 143 participants 143 participants 66 participants 857 participants
55.7  (11.0) 52.9  (10.4) 55.2  (10.6) 56.2  (10.8) 55.6  (11.2) 56.4  (10.7) 53.5  (11.1) 55.2  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 144 participants 147 participants 142 participants 143 participants 143 participants 66 participants 857 participants
Female
36
  50.0%
62
  43.1%
69
  46.9%
62
  43.7%
70
  49.0%
66
  46.2%
40
  60.6%
405
  47.3%
Male
36
  50.0%
82
  56.9%
78
  53.1%
80
  56.3%
73
  51.0%
77
  53.8%
26
  39.4%
452
  52.7%
Body Mass Index (BMI) continuous  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 72 participants 144 participants 147 participants 142 participants 143 participants 143 participants 66 participants 857 participants
28.62  (5.17) 28.92  (4.83) 29.52  (5.31) 28.95  (4.67) 29.66  (5.31) 28.55  (4.80) 28.81  (4.93) 29.07  (4.97)
Glycosylated Hemoglobin A1 (HbA1C)  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 72 participants 144 participants 147 participants 142 participants 143 participants 143 participants 66 participants 857 participants
8.67  (0.95) 8.66  (0.90) 8.52  (0.87) 8.70  (0.97) 8.71  (0.95) 8.68  (1.03) 11.84  (1.42) 8.91  (1.31)
Fasting plasma glucose (FPG)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 72 participants 144 participants 147 participants 142 participants 143 participants 143 participants 66 participants 857 participants
203.7  (51.2) 191.2  (46.9) 192.3  (52.8) 195.3  (50.2) 198.6  (60.2) 196.9  (51.2) 261.8  (80.9) 200.2  (57.3)
1.Primary Outcome
Title HbA1c Change From Baseline at Week 24
Hide Description 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.
Time Frame Baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo M500BID M1000BID Lina5 L2.5+M500BID L2.5+M1000BID
Hide Arm/Group Description:
Patients treated with matching placebo
Patients treated with Metformin 500mg BID
Patients treated with Metformin 1000mg BID
Patients treated with Linagliptin 5mg OD
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
Overall Number of Participants Analyzed 65 141 138 135 137 140
Mean (Standard Error)
Unit of Measure: Percent
0.13  (0.11) -0.64  (0.08) -1.07  (0.08) -0.45  (0.08) -1.22  (0.08) -1.59  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M500BID, L2.5+M500BID
Comments Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments hierarchical testing, no adjustment of p-values
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.58
Confidence Interval 95%
-0.79 to -0.36
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M1000BID, L2.5+M1000BID
Comments Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments hierarchical testing, no adjustment of p-values
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.51
Confidence Interval 95%
-0.73 to -0.30
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M500BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments hierarchical testing, no adjustment of p-values
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.77
Confidence Interval 95%
-0.99 to -0.55
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M1000BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments hierarchical testing, no adjustment of p-values
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.14
Confidence Interval 95%
-1.36 to -0.92
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
2.Secondary Outcome
Title HbA1c Change From Baseline at Week 6
Hide Description 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.
Time Frame Baseline and week 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo M500BID M1000BID Lina5 L2.5+M500BID L2.5+M1000BID
Hide Arm/Group Description:
Patients treated with matching placebo
Patients treated with Metformin 500mg BID
Patients treated with Metformin 1000mg BID
Patients treated with Linagliptin 5mg OD
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
Overall Number of Participants Analyzed 65 141 138 135 137 140
Mean (Standard Error)
Unit of Measure: Percent
0.03  (0.08) -0.45  (0.05) -0.61  (0.05) -0.36  (0.06) -0.86  (0.05) -1.00  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M500BID, L2.5+M500BID
Comments Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.41
Confidence Interval 95%
-0.56 to -0.26
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M1000BID, L2.5+M1000BID
Comments Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.38
Confidence Interval 95%
-0.53 to -0.23
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M500BID
Comments Linagliptin 5mg vs Linagliptin 2.5mg with metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.50
Confidence Interval 95%
-0.65 to -0.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M1000BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.64
Confidence Interval 95%
-0.79 to -0.48
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.08
Estimation Comments [Not Specified]
3.Secondary Outcome
Title HbA1c Change From Baseline at Week 12
Hide Description 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.
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo M500BID M1000BID Lina5 L2.5+M500BID L2.5+M1000BID
Hide Arm/Group Description:
Patients treated with matching placebo
Patients treated with Metformin 500mg BID
Patients treated with Metformin 1000mg BID
Patients treated with Linagliptin 5mg OD
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
Overall Number of Participants Analyzed 65 141 138 135 137 140
Mean (Standard Error)
Unit of Measure: Percent
0.16  (0.11) -0.61  (0.07) -0.95  (0.07) -0.42  (0.07) -1.13  (0.07) -1.37  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M500BID, L2.5+M500BID
Comments Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.51
Confidence Interval 95%
-0.72 to -0.31
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M1000BID, L2.5+M1000BID
Comments Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.42
Confidence Interval 95%
-0.63 to -0.22
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M500BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.71
Confidence Interval 95%
-0.92 to -0.51
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M1000BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.95
Confidence Interval 95%
-1.16 to -0.75
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments [Not Specified]
4.Secondary Outcome
Title HbA1c Change From Baseline at Week 18
Hide Description 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.
Time Frame Baseline and week 18
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo M500BID M1000BID Lina5 L2.5+M500BID L2.5+M1000BID
Hide Arm/Group Description:
Patients treated with matching placebo
Patients treated with Metformin 500mg BID
Patients treated with Metformin 1000mg BID
Patients treated with Linagliptin 5mg OD
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
Overall Number of Participants Analyzed 65 141 138 135 137 140
Mean (Standard Error)
Unit of Measure: Percent
0.16  (0.12) -0.66  (0.08) -1.06  (0.08) -0.45  (0.08) -1.17  (0.08) -1.54  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M500BID, L2.5+M500BID
Comments Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.51
Confidence Interval 95%
-0.73 to -0.29
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M1000BID, L2.5+M1000BID
Comments Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.47
Confidence Interval 95%
-0.69 to -0.26
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M500BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.72
Confidence Interval 95%
-0.94 to -0.49
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M1000BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.08
Confidence Interval 95%
-1.30 to -0.86
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
5.Secondary Outcome
Title FPG Change From Baseline at Week 24
Hide Description 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.
Time Frame Baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
Arm/Group Title Placebo M500BID M1000BID Lina5 L2.5+M500BID L2.5+M1000BID
Hide Arm/Group Description:
Patients treated with matching placebo
Patients treated with Metformin 500mg BID
Patients treated with Metformin 1000mg BID
Patients treated with Linagliptin 5mg OD
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
Overall Number of Participants Analyzed 61 136 132 134 135 136
Mean (Standard Error)
Unit of Measure: mg/dL
10.2  (5.3) -15.8  (3.5) -32.2  (3.6) -8.6  (3.6) -33.2  (3.5) -49.4  (3.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M500BID, L2.5+M500BID
Comments Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.4
Confidence Interval 95%
-27.2 to -7.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M1000BID, L2.5+M1000BID
Comments Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.2
Confidence Interval 95%
-27.1 to -7.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.0
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M500BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -24.6
Confidence Interval 95%
-34.4 to -14.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.0
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M1000BID
Comments Linagliptin 5mg vs. linagliptin 2.5mg with metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -40.8
Confidence Interval 95%
-50.6 to -31.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.0
Estimation Comments [Not Specified]
6.Secondary Outcome
Title FPG Change From Baseline at Week 2
Hide Description 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.
Time Frame Baseline and week 2
Hide Outcome Measure Data
Hide Analysis Population Description
This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
Arm/Group Title Placebo M500BID M1000BID Lina5 L2.5+M500BID L2.5+M1000BID
Hide Arm/Group Description:
Patients treated with matching placebo
Patients treated with Metformin 500mg BID
Patients treated with Metformin 1000mg BID
Patients treated with Linagliptin 5mg OD
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
Overall Number of Participants Analyzed 61 136 132 134 135 136
Mean (Standard Error)
Unit of Measure: mg/dL
5.3  (4.3) -19.6  (2.9) -21.8  (2.9) -13.0  (2.9) -34.5  (2.9) -38.6  (2.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M500BID, L2.5+M500BID
Comments Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.9
Confidence Interval 95%
-22.9 to -6.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M1000BID, L2.5+M1000BID
Comments Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.8
Confidence Interval 95%
-24.9 to -8.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M500BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -21.5
Confidence Interval 95%
-29.5 to -13.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.1
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M1000BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -25.6
Confidence Interval 95%
-33.6 to -17.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.1
Estimation Comments [Not Specified]
7.Secondary Outcome
Title FPG Change From Baseline at Week 6
Hide Description 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.
Time Frame Baseline and week 6
Hide Outcome Measure Data
Hide Analysis Population Description
This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
Arm/Group Title Placebo M500BID M1000BID Lina5 L2.5+M500BID L2.5+M1000BID
Hide Arm/Group Description:
Patients treated with matching placebo
Patients treated with Metformin 500mg BID
Patients treated with Metformin 1000mg BID
Patients treated with Linagliptin 5mg OD
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
Overall Number of Participants Analyzed 61 136 132 134 135 136
Mean (Standard Error)
Unit of Measure: mg/dL
6.2  (4.7) -20.8  (3.2) -31.6  (3.2) -10.8  (3.2) -38.7  (3.2) -48.3  (3.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M500BID, L2.5+M500BID
Comments Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.9
Confidence Interval 95%
-26.7 to -9.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M1000BID, L2.5+M1000BID
Comments Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.8
Confidence Interval 95%
-25.6 to -7.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.5
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M500BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -27.9
Confidence Interval 95%
-36.7 to -19.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.5
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M1000BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -37.6
Confidence Interval 95%
-46.4 to -28.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.5
Estimation Comments [Not Specified]
8.Secondary Outcome
Title FPG Change From Baseline at Week 12
Hide Description 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.
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
Arm/Group Title Placebo M500BID M1000BID Lina5 L2.5+M500BID L2.5+M1000BID
Hide Arm/Group Description:
Patients treated with matching placebo
Patients treated with Metformin 500mg BID
Patients treated with Metformin 1000mg BID
Patients treated with Linagliptin 5mg OD
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
Overall Number of Participants Analyzed 61 136 132 134 135 136
Mean (Standard Error)
Unit of Measure: mg/dL
8.9  (5.0) -21.8  (3.3) -31.9  (3.4) -8.4  (3.4) -36.2  (3.4) -49.9  (3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M500BID, L2.5+M500BID
Comments Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.4
Confidence Interval 95%
-23.7 to -5.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M1000BID, L2.5+M1000BID
Comments Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -18.0
Confidence Interval 95%
-27.4 to -8.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.8
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M500BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -27.8
Confidence Interval 95%
-37.1 to -18.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.7
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M1000BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -41.5
Confidence Interval 95%
-50.8 to -32.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.7
Estimation Comments [Not Specified]
9.Secondary Outcome
Title FPG Change From Baseline at Week 18
Hide Description 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.
Time Frame Baseline and week 18
Hide Outcome Measure Data
Hide Analysis Population Description
This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.
Arm/Group Title Placebo M500BID M1000BID Lina5 L2.5+M500BID L2.5+M1000BID
Hide Arm/Group Description:
Patients treated with matching placebo
Patients treated with Metformin 500mg BID
Patients treated with Metformin 1000mg BID
Patients treated with Linagliptin 5mg OD
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
Overall Number of Participants Analyzed 61 136 132 134 135 136
Mean (Standard Error)
Unit of Measure: mg/dL
7.3  (5.1) -13.7  (3.4) -30.3  (3.5) -9.2  (3.4) -34.6  (3.4) -48.1  (3.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M500BID, L2.5+M500BID
Comments Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -20.9
Confidence Interval 95%
-30.4 to -11.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M1000BID, L2.5+M1000BID
Comments Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.9
Confidence Interval 95%
-27.4 to -8.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.9
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M500BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -25.4
Confidence Interval 95%
-35.0 to -15.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.9
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M1000BID
Comments Linagliptin 5 mg vs. Linagliptin 2.5 mg with Metformin 1000 mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -39.0
Confidence Interval 95%
-48.5 to -29.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.9
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Patients With HbA1c <7.0% at Week 24
Hide Description 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%.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS treated and randomised patients with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).
Arm/Group Title Placebo M500BID M1000BID Lina5 L2.5+M500BID L2.5+M1000BID
Hide Arm/Group Description:
Patients treated with matching placebo
Patients treated with Metformin 500mg BID
Patients treated with Metformin 1000mg BID
Patients treated with Linagliptin 5mg OD
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
Overall Number of Participants Analyzed 65 140 137 135 136 138
Measure Type: Number
Unit of Measure: percentage of patients
10.8 18.6 30.7 10.4 30.1 53.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M500BID, L2.5+M500BID
Comments Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0062
Comments [Not Specified]
Method Regression, Logistic
Comments The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.372
Confidence Interval 95%
1.278 to 4.402
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M1000BID, L2.5+M1000BID
Comments Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.163
Confidence Interval 95%
2.343 to 7.397
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M500BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.854
Confidence Interval 95%
2.363 to 9.973
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M1000BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 17.094
Confidence Interval 95%
8.238 to 35.471
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Patients With HbA1c<7.0 at Week 24
Hide Description 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%.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Placebo M500BID M1000BID Lina5 L2.5+M500BID L2.5+M1000BID
Hide Arm/Group Description:
Patients treated with matching placebo
Patients treated with Metformin 500mg BID
Patients treated with Metformin 1000mg BID
Patients treated with Linagliptin 5mg OD
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
Overall Number of Participants Analyzed 65 141 138 135 137 140
Measure Type: Number
Unit of Measure: percentage of patients
10.8 19.1 31.2 10.4 30.7 54.3
12.Secondary Outcome
Title Percentage of Patients With HbA1c <6.5% at Week 24
Hide Description 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%
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS treated and randomised patients with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).
Arm/Group Title Placebo M500BID M1000BID Lina5 L2.5+M500BID L2.5+M1000BID
Hide Arm/Group Description:
Patients treated with matching placebo
Patients treated with Metformin 500mg BID
Patients treated with Metformin 1000mg BID
Patients treated with Linagliptin 5mg OD
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
Overall Number of Participants Analyzed 65 141 138 135 137 140
Measure Type: Number
Unit of Measure: percentage of patients
3.1 5.0 12.3 3.7 13.1 27.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M500BID, L2.5+M500BID
Comments Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0102
Comments [Not Specified]
Method Regression, Logistic
Comments The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.465
Confidence Interval 95%
1.342 to 8.943
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M1000BID, L2.5+M1000BID
Comments Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Regression, Logistic
Comments The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.521
Confidence Interval 95%
1.747 to 7.094
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M500BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0053
Comments [Not Specified]
Method Regression, Logistic
Comments The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.521
Confidence Interval 95%
1.564 to 13.069
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M1000BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 11.947
Confidence Interval 95%
4.314 to 33.080
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Patients With HbA1c < 6.5% at Week 24
Hide Description 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%
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Placebo M500BID M1000BID Lina5 L2.5+M500BID L2.5+M1000BID
Hide Arm/Group Description:
Patients treated with matching placebo
Patients treated with Metformin 500mg BID
Patients treated with Metformin 1000mg BID
Patients treated with Linagliptin 5mg OD
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
Overall Number of Participants Analyzed 65 141 138 135 137 140
Measure Type: Number
Unit of Measure: percentage of patients
3.1 5.0 12.3 3.7 13.1 27.1
14.Secondary Outcome
Title Percentage of Patients With HbA1c Lowering by 0.5% at Week 24
Hide Description 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%.
Time Frame Baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Placebo M500BID M1000BID Lina5 L2.5+M500BID L2.5+M1000BID
Hide Arm/Group Description:
Patients treated with matching placebo
Patients treated with Metformin 500mg BID
Patients treated with Metformin 1000mg BID
Patients treated with Linagliptin 5mg OD
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
Overall Number of Participants Analyzed 65 141 138 135 137 140
Measure Type: Number
Unit of Measure: percentage of patients
29.2 46.1 65.9 42.2 71.5 81.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M500BID, L2.5+M500BID
Comments Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.181
Confidence Interval 95%
1.903 to 5.316
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M1000BID, L2.5+M1000BID
Comments Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0027
Comments [Not Specified]
Method Regression, Logistic
Comments The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.382
Confidence Interval 95%
1.352 to 4.196
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M500BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.622
Confidence Interval 95%
2.153 to 6.093
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M1000BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.529
Confidence Interval 95%
3.724 to 11.445
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Adjusted Means for 2h Post-Prandial Glucose (PPG) Change From Baseline at Week 24
Hide Description 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.
Time Frame Baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Meal tolerance test (MTT) set (patients with adequate MTT results available at the beginning and end of the randomised treatment period)
Arm/Group Title Placebo M500BID M1000BID Lina5 L2.5+M500BID L2.5+M1000BID
Hide Arm/Group Description:
Patients treated with matching placebo
Patients treated with Metformin 500mg BID
Patients treated with Metformin 1000mg BID
Patients treated with Linagliptin 5mg OD
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
Overall Number of Participants Analyzed 6 15 14 12 10 12
Mean (Standard Error)
Unit of Measure: mg/dL
-35.4  (23.2) -82.9  (14.4) -87.2  (14.8) -35.3  (16.1) -86.0  (17.5) -109.2  (16.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M500BID, L2.5+M500BID
Comments Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8893
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.2
Confidence Interval 95%
-48.5 to 42.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 22.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M1000BID, L2.5+M1000BID
Comments Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3234
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -22.0
Confidence Interval 95%
-66.2 to 22.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 22.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M500BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0373
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -50.8
Confidence Interval 95%
-98.5 to -3.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 23.8
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M1000BID
Comments Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0018
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -73.9
Confidence Interval 95%
-119.3 to -28.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 22.7
Estimation Comments [Not Specified]
16.Secondary Outcome
Title HbA1c Change From Baseline at Week 24 for Open-label Patients
Hide Description 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.
Time Frame Baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title OL: L2.5+M1000BID
Hide Arm/Group Description:
Open label set: Linagliptin 2.5mg + Metformin 1000mg twice daily (BID)
Overall Number of Participants Analyzed 65
Mean (Standard Deviation)
Unit of Measure: Percent
-3.19  (2.04)
17.Secondary Outcome
Title FPG Change From Baseline at Week 24 for Open-label Patients
Hide Description This change from baseline reflects the Week 24 FPG minus the baseline FPG. Mean is unadjusted.
Time Frame Baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title OL: L2.5+M1000BID
Hide Arm/Group Description:
Open label set: Linagliptin 2.5mg + Metformin 1000mg twice daily (BID)
Overall Number of Participants Analyzed 55
Mean (Standard Deviation)
Unit of Measure: mg/dL
-73.58  (70.94)
18.Secondary Outcome
Title Use of Rescue Therapy
Hide Description 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.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Percentage of patients requiring rescue therapy
Arm/Group Title Placebo M500BID M1000BID Lina5 L2.5+M500BID L2.5+M1000BID
Hide Arm/Group Description:
Patients treated with matching placebo
Patients treated with Metformin 500mg BID
Patients treated with Metformin 1000mg BID
Patients treated with Linagliptin 5mg OD
Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
Overall Number of Participants Analyzed 65 141 138 135 137 140
Measure Type: Number
Unit of Measure: percentage of participants
29.2 13.5 8.0 11.1 7.3 4.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M1000BID, L2.5+M1000BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0445
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.326
Confidence Interval (2-Sided) 95%
0.109 to 0.973
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M1000BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0151
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.274
Confidence Interval (2-Sided) 95%
0.096 to 0.779
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection M500BID, L2.5+M500BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0490
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.420
Confidence Interval (2-Sided) 95%
0.177 to 0.996
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lina5, L2.5+M500BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2617
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.598
Confidence Interval (2-Sided) 95%
0.244 to 1.467
Estimation Comments [Not Specified]
Time Frame Day of first dose until day of last dose plus 7 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo M500 BID M1000 BID Lina 5 L2.5+M500 BID L2.5 + M1000 BID OL: L2.5+M1000 BID
Hide Arm/Group Description Patients treated with matching placebo Patients treated with Metformin 500 mg BID Patients treated with Metformin 1000 mg bis in die (BID) Patients treated with Linagliptin 5 mg once daily (OD) Patients treated with Linagliptin 2.5 mg + Metformin 500 mg bis in die (BID) Patients treated with Linagliptin 2.5 mg + Metformin 1000 mg bis in die (BID) Open label set: Linagliptin 2.5 mg + Metformin 1000 mg bis in die (BID)
All-Cause Mortality
Placebo M500 BID M1000 BID Lina 5 L2.5+M500 BID L2.5 + M1000 BID OL: L2.5+M1000 BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo M500 BID M1000 BID Lina 5 L2.5+M500 BID L2.5 + M1000 BID OL: L2.5+M1000 BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/72 (1.39%)   3/144 (2.08%)   6/147 (4.08%)   3/142 (2.11%)   2/143 (1.40%)   2/143 (1.40%)   1/66 (1.52%) 
Blood and lymphatic system disorders               
Thrombocytopenia  0/72 (0.00%)  1/144 (0.69%)  0/147 (0.00%)  0/142 (0.00%)  0/143 (0.00%)  0/143 (0.00%)  0/66 (0.00%) 
Cardiac disorders               
Angina pectoris  0/72 (0.00%)  0/144 (0.00%)  0/147 (0.00%)  0/142 (0.00%)  0/143 (0.00%)  1/143 (0.70%)  0/66 (0.00%) 
Angina unstable  0/72 (0.00%)  0/144 (0.00%)  0/147 (0.00%)  1/142 (0.70%)  0/143 (0.00%)  0/143 (0.00%)  0/66 (0.00%) 
Bradycardia  1/72 (1.39%)  0/144 (0.00%)  0/147 (0.00%)  0/142 (0.00%)  0/143 (0.00%)  0/143 (0.00%)  0/66 (0.00%) 
Cardiac failure congestive  0/72 (0.00%)  0/144 (0.00%)  0/147 (0.00%)  0/142 (0.00%)  0/143 (0.00%)  1/143 (0.70%)  0/66 (0.00%) 
Left ventricular failure  0/72 (0.00%)  0/144 (0.00%)  0/147 (0.00%)  1/142 (0.70%)  0/143 (0.00%)  0/143 (0.00%)  0/66 (0.00%) 
Myocardial infarction  0/72 (0.00%)  0/144 (0.00%)  1/147 (0.68%)  1/142 (0.70%)  0/143 (0.00%)  0/143 (0.00%)  0/66 (0.00%) 
Myocardial ischaemia  0/72 (0.00%)  0/144 (0.00%)  0/147 (0.00%)  1/142 (0.70%)  0/143 (0.00%)  1/143 (0.70%)  0/66 (0.00%) 
Endocrine disorders               
Hyperparathyroidism primary  0/72 (0.00%)  0/144 (0.00%)  0/147 (0.00%)  0/142 (0.00%)  1/143 (0.70%)  0/143 (0.00%)  0/66 (0.00%) 
Gastrointestinal disorders               
Haemorrhoids  0/72 (0.00%)  0/144 (0.00%)  1/147 (0.68%)  0/142 (0.00%)  0/143 (0.00%)  0/143 (0.00%)  0/66 (0.00%) 
Infections and infestations               
Erysipelas  0/72 (0.00%)  0/144 (0.00%)  1/147 (0.68%)  0/142 (0.00%)  0/143 (0.00%)  0/143 (0.00%)  0/66 (0.00%) 
Malaria  0/72 (0.00%)  1/144 (0.69%)  0/147 (0.00%)  0/142 (0.00%)  0/143 (0.00%)  0/143 (0.00%)  0/66 (0.00%) 
Plasmodium falciparum infection  0/72 (0.00%)  1/144 (0.69%)  0/147 (0.00%)  0/142 (0.00%)  0/143 (0.00%)  0/143 (0.00%)  0/66 (0.00%) 
Urinary tract infection  0/72 (0.00%)  1/144 (0.69%)  0/147 (0.00%)  0/142 (0.00%)  0/143 (0.00%)  0/143 (0.00%)  0/66 (0.00%) 
Injury, poisoning and procedural complications               
Femoral neck fracture  0/72 (0.00%)  0/144 (0.00%)  1/147 (0.68%)  0/142 (0.00%)  0/143 (0.00%)  0/143 (0.00%)  0/66 (0.00%) 
Femur fracture  0/72 (0.00%)  0/144 (0.00%)  0/147 (0.00%)  0/142 (0.00%)  1/143 (0.70%)  0/143 (0.00%)  0/66 (0.00%) 
Metabolism and nutrition disorders               
Hyperglycaemia  0/72 (0.00%)  1/144 (0.69%)  0/147 (0.00%)  0/142 (0.00%)  0/143 (0.00%)  0/143 (0.00%)  0/66 (0.00%) 
Musculoskeletal and connective tissue disorders               
Rotator cuff syndrome  0/72 (0.00%)  0/144 (0.00%)  1/147 (0.68%)  0/142 (0.00%)  0/143 (0.00%)  0/143 (0.00%)  0/66 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Bile duct cancer  0/72 (0.00%)  1/144 (0.69%)  0/147 (0.00%)  0/142 (0.00%)  0/143 (0.00%)  0/143 (0.00%)  0/66 (0.00%) 
Breast cancer stage III  0/72 (0.00%)  0/144 (0.00%)  0/147 (0.00%)  1/142 (0.70%)  0/143 (0.00%)  0/143 (0.00%)  0/66 (0.00%) 
Hodgkin's disease  0/72 (0.00%)  0/144 (0.00%)  0/147 (0.00%)  0/142 (0.00%)  0/143 (0.00%)  1/143 (0.70%)  0/66 (0.00%) 
Renal and urinary disorders               
Haematuria  0/72 (0.00%)  1/144 (0.69%)  0/147 (0.00%)  0/142 (0.00%)  0/143 (0.00%)  0/143 (0.00%)  0/66 (0.00%) 
Nephrolithiasis  0/72 (0.00%)  0/144 (0.00%)  1/147 (0.68%)  0/142 (0.00%)  0/143 (0.00%)  0/143 (0.00%)  0/66 (0.00%) 
Renal colic  0/72 (0.00%)  0/144 (0.00%)  1/147 (0.68%)  0/142 (0.00%)  0/143 (0.00%)  0/143 (0.00%)  0/66 (0.00%) 
Surgical and medical procedures               
Abortion induced  1  0/72 (0.00%)  0/144 (0.00%)  0/147 (0.00%)  0/142 (0.00%)  0/143 (0.00%)  0/143 (0.00%)  1/66 (1.52%) 
Vascular disorders               
Hypertension  0/72 (0.00%)  0/144 (0.00%)  0/147 (0.00%)  1/142 (0.70%)  0/143 (0.00%)  0/143 (0.00%)  0/66 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo M500 BID M1000 BID Lina 5 L2.5+M500 BID L2.5 + M1000 BID OL: L2.5+M1000 BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/72 (27.78%)   27/144 (18.75%)   27/147 (18.37%)   31/142 (21.83%)   31/143 (21.68%)   36/143 (25.17%)   18/66 (27.27%) 
Gastrointestinal disorders               
Diarrhoea  1  2/72 (2.78%)  3/144 (2.08%)  8/147 (5.44%)  5/142 (3.52%)  7/143 (4.90%)  11/143 (7.69%)  4/66 (6.06%) 
Infections and infestations               
Nasopharyngitis  1  1/72 (1.39%)  4/144 (2.78%)  4/147 (2.72%)  8/142 (5.63%)  12/143 (8.39%)  6/143 (4.20%)  2/66 (3.03%) 
Urinary tract infection  1  2/72 (2.78%)  3/144 (2.08%)  3/147 (2.04%)  2/142 (1.41%)  2/143 (1.40%)  7/143 (4.90%)  4/66 (6.06%) 
Investigations               
Glomerular filtration rate decreased  1  4/72 (5.56%)  4/144 (2.78%)  3/147 (2.04%)  5/142 (3.52%)  2/143 (1.40%)  6/143 (4.20%)  1/66 (1.52%) 
Metabolism and nutrition disorders               
Hyperglycaemia  1  10/72 (13.89%)  11/144 (7.64%)  3/147 (2.04%)  5/142 (3.52%)  5/143 (3.50%)  2/143 (1.40%)  7/66 (10.61%) 
Musculoskeletal and connective tissue disorders               
Back pain  1  2/72 (2.78%)  0/144 (0.00%)  5/147 (3.40%)  5/142 (3.52%)  2/143 (1.40%)  8/143 (5.59%)  2/66 (3.03%) 
Vascular disorders               
Hypertension  1  4/72 (5.56%)  5/144 (3.47%)  4/147 (2.72%)  3/142 (2.11%)  5/143 (3.50%)  5/143 (3.50%)  3/66 (4.55%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00798161     History of Changes
Other Study ID Numbers: 1218.46
2008-001640-40 ( EudraCT Number: EudraCT )
First Submitted: November 24, 2008
First Posted: November 25, 2008
Results First Submitted: May 20, 2011
Results First Posted: August 4, 2011
Last Update Posted: January 28, 2014