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Japanese P III vs Voglibose and Placebo

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ClinicalTrials.gov Identifier: NCT00654381
Recruitment Status : Completed
First Posted : April 8, 2008
Results First Posted : August 2, 2011
Last Update Posted : January 27, 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: voglibose placebo
Drug: BI 1356 placebo
Drug: voglibose
Enrollment 561
Recruitment Details Total 6 groups (including sub-groups in placebo and voglibose groups)
Pre-assignment Details

Placebo group has 2 sub-groups, placebo-linagliptin 5mg (from 2nd stage) and placebo-linagliptin 10mg (from 2nd stage).

Both Linagliptin 5 mg and 10 mg groups don't have sub-group. Voglibose group has 2 sub-groups, voglibose-linagliptin 5mg (from 3rd stage) and voglibose-linagliptin 10mg (from 3rd stage).

Arm/Group Title Placebo - BI1356 (Linagliptin) 5mg - Linagliptin 5mg Placebo - Linagliptin 5mg - Linagliptin 10mg Linagliptin 5mg - Linagliptin 5mg - Linagliptin 5mg Linagliptin 10 mg - Linagliptin 10 mg - Linagliptin 10 mg Voglibose - Voglibose - Linagliptin 5mg Voglibose - Voglibose - Linagliptin 10mg
Hide Arm/Group Description Placebo in Stage 1 - 5 mg in Stage 2 - 5 mg in Stage 3 Placebo in Stage 1 - 10 mg in Stage 2 - 10 mg in Stage 3 5 mg in Stage 1 - 5 mg in Stage 2 - 5 mg in Stage 3 10 mg in Stage 1 - 10 mg in Stage 2 - 10 mg in Stage 3 Voglibose in Stage 1 - Voglibose in Stage 2 - 5 mg in Stage 3 Voglibose in Stage 1 - Voglibose in Stage 2 - 10 mg in Stage 3
Period Title: 1st Stage
Started 39 41 159 160 81 81
Completed 36 38 156 155 79 79
Not Completed 3 3 3 5 2 2
Reason Not Completed
Adverse Event             3             3             3             3             2             1
Withdrawal by Subject             0             0             0             1             0             1
Investigator's decision             0             0             0             1             0             0
Period Title: 2nd Stage
Started 36 38 156 155 79 79
Completed 34 38 153 151 71 76
Not Completed 2 0 3 4 8 3
Reason Not Completed
Adverse Event             2             0             2             3             7             2
Withdrawal by Subject             0             0             0             0             1             1
Investigator's decision             0             0             1             1             0             0
Period Title: Extension Stage
Started 34 38 153 151 71 76
Completed 33 36 142 142 68 73
Not Completed 1 2 11 9 3 3
Reason Not Completed
Adverse Event             1             2             9             7             1             1
Protocol Violation             0             0             0             1             0             0
Lack of Efficacy             0             0             1             0             0             0
Withdrawal by Subject             0             0             1             1             1             1
Closure of the trial site             0             0             0             0             1             1
Arm/Group Title Placebo Linagliptin 5mg Linagliptin 10 mg Voglibose Total
Hide Arm/Group Description The patients with placebo at the start of randomised study medication The patients with linagliptin 5 mg at the start of randomised study medication The patients with linagliptin 10 mg at the start of randomised study medication The patients with voglibose at the start of randomised study medication Total of all reporting groups
Overall Number of Baseline Participants 80 159 160 162 561
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants 159 participants 160 participants 162 participants 561 participants
59.7  (8.9) 60.3  (9.4) 61.3  (10) 58.5  (9.9) 60.0  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 159 participants 160 participants 162 participants 561 participants
Female
23
  28.7%
48
  30.2%
48
  30.0%
47
  29.0%
166
  29.6%
Male
57
  71.3%
111
  69.8%
112
  70.0%
115
  71.0%
395
  70.4%
1.Primary Outcome
Title Change From Baseline in HbA1c at Week 12
Hide Description Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.
Arm/Group Title Placebo Linagliptin 5mg Linagliptin 10 mg
Hide Arm/Group Description:
The patients with placebo at the start of randomised study medication
The patients with linagliptin 5 mg at the start of randomised study medication
The patients with linagliptin 10 mg at the start of randomised study medication
Overall Number of Participants Analyzed 80 159 157
Least Squares Mean (Standard Error)
Unit of Measure: Percent
0.63  (0.08) -0.24  (0.06) -0.25  (0.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Linagliptin 5mg
Comments Linagliptin 5 mg vs placebo at week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.87
Confidence Interval (2-Sided) 95%
-1.04 to -0.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Linagliptin 10 mg
Comments Linagliptin 10 mg vs placebo at week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.88
Confidence Interval (2-Sided) 95%
-1.05 to -0.71
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in HbA1c at Week 26
Hide Description Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward.
Arm/Group Title Linagliptin 5mg Linagliptin 10 mg Voglibose
Hide Arm/Group Description:
The patients with linagliptin 5 mg at the start of randomised study medication
The patients with linagliptin 10 mg at the start of randomised study medication
The patients with voglibose at the start of randomised study medication
Overall Number of Participants Analyzed 159 157 162
Least Squares Mean (Standard Error)
Unit of Measure: Percent
-0.13  (0.07) -0.19  (0.07) 0.19  (0.07)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Linagliptin 5mg, Voglibose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method ANCOVA
Comments Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-0.49 to -0.15
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Linagliptin 10 mg, Voglibose
Comments Linagliptin 10 mg vs voglibose at week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-0.56 to -0.21
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments [Not Specified]
3.Primary Outcome
Title Examination of Long-term Safety of Linagliptin (52-week Treatment)
Hide Description The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The patients who received at least one dose of linagliptin 5 mg or linagliptin 10 mg during the randomised treatment period
Arm/Group Title Linagliptin 5mg Linagliptin 10 mg
Hide Arm/Group Description:
The patients with linagliptin 5 mg at the start of randomised study medication
The patients with linagliptin 10 mg at the start of randomised study medication
Overall Number of Participants Analyzed 266 274
Measure Type: Number
Unit of Measure: participants
Nasopharyngitis 84 81
Back pain 15 21
Constipation 12 19
4.Secondary Outcome
Title Relative Efficacy Response of HbA1c at Week 12
Hide Description HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 12
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.
Arm/Group Title Placebo Linagliptin 5mg Linagliptin 10 mg
Hide Arm/Group Description:
The patients with placebo at the start of randomised study medication
The patients with linagliptin 5 mg at the start of randomised study medication
The patients with linagliptin 10 mg at the start of randomised study medication
Overall Number of Participants Analyzed 80 159 157
Measure Type: Number
Unit of Measure: Participants
HbA1c <7.0% 8 42 56
HbA1c <6.5% 0 15 18
HbA1c reduction from baseline ≥0.5% 7 91 94
5.Secondary Outcome
Title Relative Efficacy Response of HbA1c at Week 26
Hide Description HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 26
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward.
Arm/Group Title Linagliptin 5mg Linagliptin 10 mg Voglibose
Hide Arm/Group Description:
The patients with linagliptin 5 mg at the start of randomised study medication
The patients with linagliptin 10 mg at the start of randomised study medication
The patients with voglibose at the start of randomised study medication
Overall Number of Participants Analyzed 159 157 162
Measure Type: Number
Unit of Measure: Participants
HbA1c <7.0% 48 54 36
HbA1c <6.5% 15 21 7
HbA1c reduction from baseline ≥0.5% 91 84 61
6.Secondary Outcome
Title Relative Efficacy Response of HbA1c at Week 52
Hide Description HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 52
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For the 52-week analysis, it was planed to analyse for Linagliptin 5mg and 10mg. Then the patients with placebo and voglibose were excluded in this analysis. Full analysis set for 52-week treatment period with Last Observation Carried Forward
Arm/Group Title Linagliptin 5mg Linagliptin 10mg
Hide Arm/Group Description:
The patients with linagliptin 5 mg at the start of randomised study medication
The patients with linagliptin 10 mg at the start of randomised study medication
Overall Number of Participants Analyzed 159 157
Measure Type: Number
Unit of Measure: Participants
HbA1c <7.0% 38 29
HbA1c <6.5% 6 10
HbA1c reduction from baseline ≥0.5% 62 62
7.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Hide Description Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.
Arm/Group Title Placebo Linagliptin 5mg Linagliptin 10 mg
Hide Arm/Group Description:
The patients with placebo at the start of randomised study medication
The patients with linagliptin 5 mg at the start of randomised study medication
The patients with linagliptin 10 mg at the start of randomised study medication
Overall Number of Participants Analyzed 80 159 160
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
7.4  (2.5) -12.3  (1.9) -13.0  (1.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Linagliptin 5mg
Comments Linagliptin 5 mg vs placebo at week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Model includes treatment,baseline FPG, and number of previous antidiabetic medication
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -19.7
Confidence Interval (2-Sided) 95%
-25.4 to -14.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Linagliptin 10 mg
Comments Linagliptin 10 mg vs placebo at week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Model includes treatment,baseline FPG, and number of previous antidiabetic medication
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -20.4
Confidence Interval (2-Sided) 95%
-26.2 to -14.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.9
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Hide Description Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward
Arm/Group Title Linagliptin 5mg Linagliptin 10 mg Voglibose
Hide Arm/Group Description:
The patients with linagliptin 5 mg at the start of randomised study medication
The patients with linagliptin 10 mg at the start of randomised study medication
The patients with voglibose at the start of randomised study medication
Overall Number of Participants Analyzed 159 160 162
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-5.0  (2.4) -7.8  (2.4) 2.0  (2.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Linagliptin 5mg, Voglibose
Comments Linagliptin 5 mg vs Voglibose at week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0239
Comments [Not Specified]
Method ANCOVA
Comments Model includes treatment,baseline FPG, and number of previous antidiabetic medication
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -6.9
Confidence Interval (2-Sided) 95%
-13.0 to -0.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Linagliptin 10 mg, Voglibose
Comments Linagliptin 10 mg vs voglibose at week 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0015
Comments [Not Specified]
Method ANCOVA
Comments Model includes treatment,baseline FPG, and number of previous antidiabetic medication
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -9.8
Confidence Interval (2-Sided) 95%
-15.8 to -3.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.1
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Hide Description Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The patients who had at least one available baseline FPG measurement under the treatment with linagliptin
Arm/Group Title Linagliptin 5mg Linagliptin 10 mg
Hide Arm/Group Description:
The patients with linagliptin 5 mg at the start of randomised study medication
The patients with linagliptin 10 mg at the start of randomised study medication
Overall Number of Participants Analyzed 159 160
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-3.2  (2.7) -5.9  (2.7)
Time Frame 52 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo (1st Stage) Linagliptin 5mg (2nd-Extension Stage After Placebo) Linagliptin 10mg (2nd-Extension Stage After Placebo) Linagliptin 5mg (1st-2nd-Extension Stage) Linagliptin 10mg (1st-2nd-Extension Stage) Voglibose (1st-2nd Stage) Linagliptin 5mg (Extension Stage After Voglibose) Linagliptin 10mg (Extension Stage After Voglibose)
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Placebo (1st Stage) Linagliptin 5mg (2nd-Extension Stage After Placebo) Linagliptin 10mg (2nd-Extension Stage After Placebo) Linagliptin 5mg (1st-2nd-Extension Stage) Linagliptin 10mg (1st-2nd-Extension Stage) Voglibose (1st-2nd Stage) Linagliptin 5mg (Extension Stage After Voglibose) Linagliptin 10mg (Extension Stage After Voglibose)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo (1st Stage) Linagliptin 5mg (2nd-Extension Stage After Placebo) Linagliptin 10mg (2nd-Extension Stage After Placebo) Linagliptin 5mg (1st-2nd-Extension Stage) Linagliptin 10mg (1st-2nd-Extension Stage) Voglibose (1st-2nd Stage) Linagliptin 5mg (Extension Stage After Voglibose) Linagliptin 10mg (Extension Stage After Voglibose)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/80 (1.25%)   3/36 (8.33%)   1/38 (2.63%)   14/159 (8.81%)   10/160 (6.25%)   7/162 (4.32%)   3/71 (4.23%)   3/76 (3.95%) 
Cardiac disorders                 
Acute coronary syndrome  1  0/80 (0.00%)  0/36 (0.00%)  1/38 (2.63%)  0/159 (0.00%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Acute myocardial infarction  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  1/159 (0.63%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Angina pectoris  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  1/159 (0.63%)  0/160 (0.00%)  2/162 (1.23%)  0/71 (0.00%)  0/76 (0.00%) 
Angina unstable  1  0/80 (0.00%)  1/36 (2.78%)  0/38 (0.00%)  0/159 (0.00%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Arrhythmia  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  0/159 (0.00%)  1/160 (0.63%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Atrial fibrillation  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  1/159 (0.63%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Cardiac failure congestive  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  1/159 (0.63%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Coronary artery occlusion  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  1/159 (0.63%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Endocrine disorders                 
Hyperthyroidism  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  1/159 (0.63%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Eye disorders                 
Cataract  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  0/159 (0.00%)  1/160 (0.63%)  1/162 (0.62%)  0/71 (0.00%)  1/76 (1.32%) 
Gastrointestinal disorders                 
Abdominal hernia  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  1/159 (0.63%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Colonic polyp  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  1/159 (0.63%)  1/160 (0.63%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Gastric ulcer  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  1/159 (0.63%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Haemorrhoids  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  0/159 (0.00%)  1/160 (0.63%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Inguinal hernia  1  1/80 (1.25%)  0/36 (0.00%)  0/38 (0.00%)  0/159 (0.00%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Hepatobiliary disorders                 
Bile duct stone  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  1/159 (0.63%)  1/160 (0.63%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Cholangitis  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  1/159 (0.63%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Infections and infestations                 
Bronchitis  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  1/159 (0.63%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Herpes zoster  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  0/159 (0.00%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  1/76 (1.32%) 
Osteomyelitis  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  0/159 (0.00%)  1/160 (0.63%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Injury, poisoning and procedural complications                 
Airway burns  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  0/159 (0.00%)  1/160 (0.63%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Clavicle fracture  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  0/159 (0.00%)  1/160 (0.63%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Contusion  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  1/159 (0.63%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Fall  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  1/159 (0.63%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Road traffic accident  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  0/159 (0.00%)  1/160 (0.63%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Metabolism and nutrition disorders                 
Diabetes mellitus  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  0/159 (0.00%)  0/160 (0.00%)  0/162 (0.00%)  1/71 (1.41%)  0/76 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Arthritis  1  0/80 (0.00%)  1/36 (2.78%)  0/38 (0.00%)  0/159 (0.00%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Back pain  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  1/159 (0.63%)  0/160 (0.00%)  0/162 (0.00%)  1/71 (1.41%)  0/76 (0.00%) 
Limb deformity  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  0/159 (0.00%)  0/160 (0.00%)  1/162 (0.62%)  0/71 (0.00%)  0/76 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Bladder cancer recurrent  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  0/159 (0.00%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  1/76 (1.32%) 
Gastric cancer  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  1/159 (0.63%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Gastric cancer recurrent  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  1/159 (0.63%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Large intestine carcinoma  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  1/159 (0.63%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Lung neoplasm malignant  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  0/159 (0.00%)  0/160 (0.00%)  1/162 (0.62%)  0/71 (0.00%)  0/76 (0.00%) 
Metastases to liver  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  0/159 (0.00%)  1/160 (0.63%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Pancreatic carcinoma  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  0/159 (0.00%)  1/160 (0.63%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Prostate cancer  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  1/159 (0.63%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Nervous system disorders                 
Carpal tunnel syndrome  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  0/159 (0.00%)  0/160 (0.00%)  1/162 (0.62%)  0/71 (0.00%)  0/76 (0.00%) 
Cerebral infarction  1  0/80 (0.00%)  1/36 (2.78%)  0/38 (0.00%)  0/159 (0.00%)  1/160 (0.63%)  0/162 (0.00%)  1/71 (1.41%)  0/76 (0.00%) 
Cerebral haemorrhage  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  1/159 (0.63%)  0/160 (0.00%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Renal and urinary disorders                 
Calculus ureteric  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  0/159 (0.00%)  0/160 (0.00%)  1/162 (0.62%)  0/71 (0.00%)  0/76 (0.00%) 
Nephrolithiasis  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  0/159 (0.00%)  1/160 (0.63%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Vascular disorders                 
Hypertension  1  0/80 (0.00%)  0/36 (0.00%)  0/38 (0.00%)  0/159 (0.00%)  1/160 (0.63%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 12.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (1st Stage) Linagliptin 5mg (2nd-Extension Stage After Placebo) Linagliptin 10mg (2nd-Extension Stage After Placebo) Linagliptin 5mg (1st-2nd-Extension Stage) Linagliptin 10mg (1st-2nd-Extension Stage) Voglibose (1st-2nd Stage) Linagliptin 5mg (Extension Stage After Voglibose) Linagliptin 10mg (Extension Stage After Voglibose)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23/80 (28.75%)   19/36 (52.78%)   21/38 (55.26%)   101/159 (63.52%)   107/160 (66.88%)   83/162 (51.23%)   28/71 (39.44%)   31/76 (40.79%) 
Eye disorders                 
Cataract  1  0/80 (0.00%)  0/36 (0.00%)  3/38 (7.89%)  2/159 (1.26%)  2/160 (1.25%)  2/162 (1.23%)  2/71 (2.82%)  1/76 (1.32%) 
Gastrointestinal disorders                 
Abdominal pain upper  1  0/80 (0.00%)  1/36 (2.78%)  2/38 (5.26%)  3/159 (1.89%)  3/160 (1.88%)  2/162 (1.23%)  2/71 (2.82%)  1/76 (1.32%) 
Constipation  1  5/80 (6.25%)  0/36 (0.00%)  4/38 (10.53%)  12/159 (7.55%)  12/160 (7.50%)  5/162 (3.09%)  0/71 (0.00%)  3/76 (3.95%) 
Dental caries  1  0/80 (0.00%)  0/36 (0.00%)  2/38 (5.26%)  7/159 (4.40%)  5/160 (3.13%)  4/162 (2.47%)  1/71 (1.41%)  0/76 (0.00%) 
Diarrhoea  1  1/80 (1.25%)  0/36 (0.00%)  0/38 (0.00%)  10/159 (6.29%)  6/160 (3.75%)  15/162 (9.26%)  0/71 (0.00%)  0/76 (0.00%) 
Flatulence  1  1/80 (1.25%)  0/36 (0.00%)  1/38 (2.63%)  4/159 (2.52%)  7/160 (4.38%)  10/162 (6.17%)  0/71 (0.00%)  0/76 (0.00%) 
Nausea  1  1/80 (1.25%)  2/36 (5.56%)  0/38 (0.00%)  1/159 (0.63%)  1/160 (0.63%)  1/162 (0.62%)  0/71 (0.00%)  1/76 (1.32%) 
Infections and infestations                 
Nasopharyngitis  1  10/80 (12.50%)  10/36 (27.78%)  8/38 (21.05%)  60/159 (37.74%)  57/160 (35.63%)  36/162 (22.22%)  14/71 (19.72%)  16/76 (21.05%) 
Rhinitis  1  0/80 (0.00%)  2/36 (5.56%)  2/38 (5.26%)  2/159 (1.26%)  3/160 (1.88%)  2/162 (1.23%)  1/71 (1.41%)  0/76 (0.00%) 
Bronchitis  1  0/80 (0.00%)  1/36 (2.78%)  2/38 (5.26%)  7/159 (4.40%)  6/160 (3.75%)  4/162 (2.47%)  1/71 (1.41%)  0/76 (0.00%) 
Cystitis  1  1/80 (1.25%)  0/36 (0.00%)  2/38 (5.26%)  3/159 (1.89%)  1/160 (0.63%)  4/162 (2.47%)  1/71 (1.41%)  2/76 (2.63%) 
Gastroenteritis  1  1/80 (1.25%)  1/36 (2.78%)  2/38 (5.26%)  4/159 (2.52%)  3/160 (1.88%)  2/162 (1.23%)  3/71 (4.23%)  1/76 (1.32%) 
Injury, poisoning and procedural complications                 
Contusion  1  1/80 (1.25%)  1/36 (2.78%)  2/38 (5.26%)  5/159 (3.14%)  4/160 (2.50%)  3/162 (1.85%)  0/71 (0.00%)  0/76 (0.00%) 
Metabolism and nutrition disorders                 
Diabetes mellitus  1  4/80 (5.00%)  3/36 (8.33%)  0/38 (0.00%)  7/159 (4.40%)  7/160 (4.38%)  7/162 (4.32%)  1/71 (1.41%)  4/76 (5.26%) 
Musculoskeletal and connective tissue disorders                 
Arthralgia  1  0/80 (0.00%)  1/36 (2.78%)  2/38 (5.26%)  4/159 (2.52%)  3/160 (1.88%)  2/162 (1.23%)  0/71 (0.00%)  1/76 (1.32%) 
Back pain  1  2/80 (2.50%)  1/36 (2.78%)  2/38 (5.26%)  11/159 (6.92%)  15/160 (9.38%)  6/162 (3.70%)  1/71 (1.41%)  4/76 (5.26%) 
Spinal osteoarthritis  1  0/80 (0.00%)  2/36 (5.56%)  0/38 (0.00%)  1/159 (0.63%)  2/160 (1.25%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Nervous system disorders                 
Dizziness  1  0/80 (0.00%)  0/36 (0.00%)  2/38 (5.26%)  3/159 (1.89%)  2/160 (1.25%)  4/162 (2.47%)  1/71 (1.41%)  0/76 (0.00%) 
Psychiatric disorders                 
Depression  1  0/80 (0.00%)  0/36 (0.00%)  2/38 (5.26%)  0/159 (0.00%)  1/160 (0.63%)  0/162 (0.00%)  0/71 (0.00%)  0/76 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Upper respiratory tract inflammation  1  0/80 (0.00%)  1/36 (2.78%)  2/38 (5.26%)  9/159 (5.66%)  10/160 (6.25%)  2/162 (1.23%)  2/71 (2.82%)  1/76 (1.32%) 
Skin and subcutaneous tissue disorders                 
Eczema  1  0/80 (0.00%)  2/36 (5.56%)  1/38 (2.63%)  6/159 (3.77%)  5/160 (3.13%)  2/162 (1.23%)  1/71 (1.41%)  0/76 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 12.1
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: NCT00654381    
Other Study ID Numbers: 1218.23
First Submitted: April 3, 2008
First Posted: April 8, 2008
Results First Submitted: May 18, 2011
Results First Posted: August 2, 2011
Last Update Posted: January 27, 2014