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Trial record 70 of 10868 for:    Placebo AND once

Efficacy vs Placebo as Initial Combination Therapy With Pioglitazone

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ClinicalTrials.gov Identifier: NCT00641043
Recruitment Status : Completed
First Posted : March 21, 2008
Results First Posted : June 7, 2011
Last Update Posted : February 17, 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: placebo + pioglitazone (30 mg)
Drug: Linagliptin + pioglitazone (30 mg)
Enrollment 389
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo + Pioglitazone Linagliptin + Pioglitazone
Hide Arm/Group Description Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
Period Title: Overall Study
Started 130 [1] 259 [1]
Completed 111 [2] 244 [2]
Not Completed 19 15
Reason Not Completed
Adverse Event             6             4
Protocol Violation             2             3
Lost to Follow-up             3             2
Withdrawal by Subject             4             4
Other incl. lack of efficacy             4             2
[1]
number who started treatment
[2]
number who completed treatment
Arm/Group Title Placebo + Pioglitazone Linagliptin + Pioglitazone Total
Hide Arm/Group Description Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg Total of all reporting groups
Overall Number of Baseline Participants 130 259 389
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 130 participants 259 participants 389 participants
57.1  (10.1) 57.7  (9.6) 57.5  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 259 participants 389 participants
Female
45
  34.6%
107
  41.3%
152
  39.1%
Male
85
  65.4%
152
  58.7%
237
  60.9%
Body mass index continuous  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 130 participants 259 participants 389 participants
29.72  (4.84) 28.68  (4.82) 29.02  (4.85)
Glycosylated haemoglobin A1 (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 130 participants 259 participants 389 participants
8.58  (0.87) 8.60  (0.79) 8.59  (0.82)
Fasting Plasma Glucose (FPG)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 130 participants 259 participants 389 participants
190.3  (43.8) 189.8  (42.7) 189.9  (43.0)
1.Primary Outcome
Title HbA1c Change From Baseline to 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 + Pioglitazone Linagliptin + Pioglitazone
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
Overall Number of Participants Analyzed 128 252
Mean (Standard Error)
Unit of Measure: Percent
-0.56  (0.09) -1.06  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Pioglitazone, Linagliptin + Pioglitazone
Comments Linagliptin vs. Placebo
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%
-0.71 to -0.30
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments [Not Specified]
2.Secondary Outcome
Title HbA1c Change From Baseline to 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 randomised and treated 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 + Pioglitazone Linagliptin + Pioglitazone
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
Overall Number of Participants Analyzed 128 252
Mean (Standard Error)
Unit of Measure: Percent
-0.03  (0.06) -0.41  (0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Pioglitazone, Linagliptin + Pioglitazone
Comments Linagliptin vs. Placebo
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%
-0.52 to -0.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.07
Estimation Comments [Not Specified]
3.Secondary Outcome
Title HbA1c Change From Baseline to 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 randomised and treated 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 + Pioglitazone Linagliptin + Pioglitazone
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
Overall Number of Participants Analyzed 128 252
Mean (Standard Error)
Unit of Measure: Percent
-0.35  (0.07) -0.85  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Pioglitazone, Linagliptin + Pioglitazone
Comments Linagliptin vs. Placebo
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%
-0.67 to -0.32
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.09
Estimation Comments [Not Specified]
4.Secondary Outcome
Title HbA1c Change From Baseline to 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 + Pioglitazone Linagliptin + Pioglitazone
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
Overall Number of Participants Analyzed 128 252
Mean (Standard Error)
Unit of Measure: Percent
-0.55  (0.08) -1.06  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Pioglitazone, Linagliptin + Pioglitazone
Comments Linagliptin vs. Placebo
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%
-0.70 to -0.32
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.10
Estimation Comments [Not Specified]
5.Secondary Outcome
Title FPG Change From Baseline to 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 + Pioglitazone Linagliptin + Pioglitazone
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
Overall Number of Participants Analyzed 122 243
Mean (Standard Error)
Unit of Measure: mg/dL
-18.4  (3.0) -32.6  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Pioglitazone, Linagliptin + Pioglitazone
Comments Linagliptin vs. Placebo
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 -14.2
Confidence Interval 95%
-21.1 to -7.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.5
Estimation Comments [Not Specified]
6.Secondary Outcome
Title FPG Change From Baseline to 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 + Pioglitazone Linagliptin + Pioglitazone
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
Overall Number of Participants Analyzed 122 243
Mean (Standard Error)
Unit of Measure: mg/dL
-17.0  (2.5) -33.3  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Pioglitazone, Linagliptin + Pioglitazone
Comments Linagliptin vs. Placebo
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 -16.4
Confidence Interval 95%
-22.3 to -10.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.0
Estimation Comments [Not Specified]
7.Secondary Outcome
Title FPG Change From Baseline to 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 + Pioglitazone Linagliptin + Pioglitazone
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
Overall Number of Participants Analyzed 122 243
Mean (Standard Error)
Unit of Measure: mg/dL
-20.5  (2.7) -33.8  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Pioglitazone, Linagliptin + Pioglitazone
Comments Linagliptin vs. Placebo
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 -13.2
Confidence Interval 95%
-19.5 to -7.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.2
Estimation Comments [Not Specified]
8.Secondary Outcome
Title FPG Change From Baseline to 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-diabetes 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 + Pioglitazone Linagliptin + Pioglitazone
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
Overall Number of Participants Analyzed 122 243
Mean (Standard Error)
Unit of Measure: mg/dL
-19.3  (2.9) -33.2  (2.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Pioglitazone, Linagliptin + Pioglitazone
Comments Linagliptin vs. Placebo
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 -13.9
Confidence Interval 95%
-20.5 to -7.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.4
Estimation Comments [Not Specified]
9.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%. Only patients with baseline HbA1c >= 7%
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).
Arm/Group Title Placebo + Pioglitazone Linagliptin + Pioglitazone
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
Overall Number of Participants Analyzed 128 252
Measure Type: Number
Unit of Measure: percentage of patients
30.5 42.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Pioglitazone, Linagliptin + Pioglitazone
Comments

Linagliptin vs. Placebo

The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0051
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.103
Confidence Interval 95%
1.25 to 3.539
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
This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).
Arm/Group Title Placebo + Pioglitazone Linagliptin + Pioglitazone
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
Overall Number of Participants Analyzed 128 252
Measure Type: Number
Unit of Measure: percentage of patients
30.5 42.9
11.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
This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).
Arm/Group Title Placebo + Pioglitazone Linagliptin + Pioglitazone
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
Overall Number of Participants Analyzed 128 252
Measure Type: Number
Unit of Measure: percentage of patients
14.1 17.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Pioglitazone, Linagliptin + Pioglitazone
Comments

Linagliptin vs. Placebo

The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3547
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.348
Confidence Interval 95%
0.716 to 2.537
Estimation Comments [Not Specified]
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%
Time Frame Baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
This population includes the Full Analysis Set (FAS). Non-completers were considered as failure imputation (NCF).
Arm/Group Title Placebo + Pioglitazone Linagliptin + Pioglitazone
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
Overall Number of Participants Analyzed 128 252
Measure Type: Number
Unit of Measure: percentage of patients
14.1 17.5
13.Secondary Outcome
Title Percentage of Patients Who Have an 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 Full Analysis Set (FAS) included all 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 + Pioglitazone Linagliptin + Pioglitazone
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg
Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
Overall Number of Participants Analyzed 128 252
Measure Type: Number
Unit of Measure: percentage of patients
50.8 75.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Pioglitazone, Linagliptin + Pioglitazone
Comments

Linagliptin vs. Placebo

The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication.

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 [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.823
Confidence Interval 95%
2.286 to 6.394
Estimation Comments [Not Specified]
Time Frame From day of first dose until 7 days after last dose, up to 202 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo + Pioglitazone Linagliptin + Pioglitazone
Hide Arm/Group Description Patients randomized to receive treatment with matching placebo (to Linagliptin 5 mg) and Pioglitazone 30 mg Patients randomized to receive treatment with Linagliptin 5 mg and Pioglitazone 30 mg
All-Cause Mortality
Placebo + Pioglitazone Linagliptin + Pioglitazone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo + Pioglitazone Linagliptin + Pioglitazone
Affected / at Risk (%) Affected / at Risk (%)
Total   3/130 (2.31%)   8/259 (3.09%) 
Cardiac disorders     
Acute coronary syndrome  1  0/130 (0.00%)  1/259 (0.39%) 
Eye disorders     
Glaucoma  1  1/130 (0.77%)  0/259 (0.00%) 
Gastrointestinal disorders     
Abdominal pain upper  1  0/130 (0.00%)  1/259 (0.39%) 
Colonic polyp  1  0/130 (0.00%)  1/259 (0.39%) 
Vomiting  1  0/130 (0.00%)  1/259 (0.39%) 
Hepatobiliary disorders     
Cholecystitis acute  1  1/130 (0.77%)  0/259 (0.00%) 
Cholelithiasis  1  1/130 (0.77%)  1/259 (0.39%) 
Musculoskeletal and connective tissue disorders     
Tendonitis  1  1/130 (0.77%)  0/259 (0.00%) 
Nervous system disorders     
Carotid artery stenosis  1  0/130 (0.00%)  1/259 (0.39%) 
Hypoaesthesia  1  0/130 (0.00%)  1/259 (0.39%) 
Surgical and medical procedures     
Meniscus removal  1  0/130 (0.00%)  1/259 (0.39%) 
Vascular disorders     
Varicose vein  1  0/130 (0.00%)  1/259 (0.39%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo + Pioglitazone Linagliptin + Pioglitazone
Affected / at Risk (%) Affected / at Risk (%)
Total   21/130 (16.15%)   33/259 (12.74%) 
Infections and infestations     
Nasopharyngitis  1  11/130 (8.46%)  24/259 (9.27%) 
Upper respiratory tract infection  1  10/130 (7.69%)  9/259 (3.47%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00641043     History of Changes
Other Study ID Numbers: 1218.15
2007-002456-41 ( EudraCT Number: EudraCT )
First Submitted: February 29, 2008
First Posted: March 21, 2008
Results First Submitted: May 13, 2011
Results First Posted: June 7, 2011
Last Update Posted: February 17, 2014