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Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes

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: NCT00954447
Recruitment Status : Completed
First Posted : August 7, 2009
Results First Posted : September 27, 2012
Last Update Posted : December 30, 2013
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
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
Drug: Linagliptin
Enrollment 1263
Recruitment Details  
Pre-assignment Details Randomised, double-blind, placebo-controlled, parallel group study. Whilst 1263 were randomised, only 1261 were treated.
Arm/Group Title Placebo Linagliptin 5 mg
Hide Arm/Group Description Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted. Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Period Title: Overall Study
Started 630 631
Completed 520 543
Not Completed 110 88
Reason Not Completed
Adverse Event             33             25
Lack of Efficacy             17             3
Protocol Violation             5             7
Lost to Follow-up             8             14
Withdrawal by Subject             26             21
Other             21             18
Arm/Group Title Placebo Linagliptin 5 mg Total
Hide Arm/Group Description Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted. Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted. Total of all reporting groups
Overall Number of Baseline Participants 630 631 1261
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 630 participants 631 participants 1261 participants
60.4  (10.0) 59.7  (9.9) 60.0  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 630 participants 631 participants 1261 participants
Female
301
  47.8%
302
  47.9%
603
  47.8%
Male
329
  52.2%
329
  52.1%
658
  52.2%
Baseline HbA1c   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 630 participants 631 participants 1261 participants
8.29  (0.85) 8.31  (0.85) 8.30  (0.85)
[1]
Measure Description: Baseline HbA1c was defined as the last available HbA1c measurement prior to the start of randomised study treatment.There were 617 patients with non-missing baseline HbA1c in Placebo group and 618 patients with non-missing values in Linagliptin 5 mg.
1.Primary Outcome
Title Change From Baseline in HbA1c After 24 Weeks
Hide Description HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) with a last observation carried forward (LOCF) approach. The FAS comprises all randomised patients who were treated with at least one dose of study medication, had a baseline HbA1c measurement, and had at least one on-treatment HbA1c measurement within the first 24 weeks of double-blind treatment.
Arm/Group Title Placebo Linagliptin 5 mg
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed 617 618
Mean (Standard Error)
Unit of Measure: Percentage
0.07  (0.08) -0.58  (0.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Linagliptin 5 mg
Comments [Not Specified]
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 -0.65
Confidence Interval 95%
-0.74 to -0.55
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.05
Estimation Comments Linagliptin 5mg - Placebo
2.Secondary Outcome
Title Number of Patients With HbA1c < 7.0 Percent
Hide Description [Not Specified]
Time Frame 24 and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS using the non-completers considered failure (NCF) approach, in which missing data due to premature discontinuation of a patient were considered as failure.
Arm/Group Title Placebo Linagliptin 5 mg
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed 617 618
Measure Type: Number
Unit of Measure: Participants
after 24 weeks of treatment 56 134
after 52 weeks of treatment 44 109
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Linagliptin 5 mg
Comments FAS with baseline HbA1c >= 7.0 percent (NCF); there are 593 available values for Placebo and 595 for Linagliptin 5mg
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 Logistic regression of HbA1c < 7.0 percent at week 52
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.935
Confidence Interval 95%
1.949 to 4.419
Estimation Comments Linagliptin 5mg vs. Placebo OR adjusted for baseline HbA1c, categorical renal function impairment, concomitant OADs and treatment
3.Secondary Outcome
Title Number of Patients Lowering HbA1c by at Least 0.5 Percent
Hide Description [Not Specified]
Time Frame 24 and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (NCF)
Arm/Group Title Placebo Linagliptin 5 mg
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed 617 618
Measure Type: Number
Unit of Measure: Participants
after 24 weeks of treatment 137 333
after 52 weeks of treatment 104 231
4.Secondary Outcome
Title Change From Baseline in HbA1c by Visit at Week 6
Hide Description Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (LOCF)
Arm/Group Title Placebo Linagliptin 5 mg
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed 617 618
Mean (Standard Error)
Unit of Measure: Percentage
0.00  (0.05) -0.45  (0.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Linagliptin 5 mg
Comments [Not Specified]
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 -0.45
Confidence Interval 95%
-0.51 to -0.39
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.03
Estimation Comments Linagliptin 5mg - Placebo
5.Secondary Outcome
Title Change From Baseline in HbA1c by Visit at Week 12
Hide Description Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (LOCF)
Arm/Group Title Placebo Linagliptin 5 mg
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed 617 618
Mean (Standard Error)
Unit of Measure: Percentage
0.02  (0.07) -0.59  (0.07)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Linagliptin 5 mg
Comments [Not Specified]
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 -0.61
Confidence Interval 95%
-0.69 to -0.52
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.04
Estimation Comments Linagliptin 5mg - Placebo
6.Secondary Outcome
Title Change From Baseline in HbA1c by Visit at Week 18
Hide Description Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Time Frame Baseline and 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (LOCF)
Arm/Group Title Placebo Linagliptin 5 mg
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed 617 618
Mean (Standard Error)
Unit of Measure: Percentage
0.03  (0.08) -0.64  (0.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Linagliptin 5 mg
Comments [Not Specified]
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 -0.67
Confidence Interval 95%
-0.76 to -0.57
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.05
Estimation Comments Linagliptin 5mg - Placebo
7.Secondary Outcome
Title Change From Baseline in HbA1c by Visit at Week 32
Hide Description Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Time Frame Baseline and 32 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (LOCF)
Arm/Group Title Placebo Linagliptin 5 mg
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed 617 618
Mean (Standard Error)
Unit of Measure: Percentage
0.01  (0.08) -0.56  (0.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Linagliptin 5 mg
Comments [Not Specified]
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 -0.57
Confidence Interval 95%
-0.67 to -0.47
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.05
Estimation Comments Linagliptin 5mg - Placebo
8.Secondary Outcome
Title Change From Baseline in HbA1c by Visit at Week 40
Hide Description Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Time Frame Baseline and 40 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (LOCF)
Arm/Group Title Placebo Linagliptin 5 mg
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed 617 618
Mean (Standard Error)
Unit of Measure: Percentage
0.05  (0.08) -0.50  (0.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Linagliptin 5 mg
Comments [Not Specified]
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 -0.55
Confidence Interval 95%
-0.65 to -0.45
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.05
Estimation Comments Linagliptin 5mg - Placebo
9.Secondary Outcome
Title Change From Baseline in HbA1c by Visit at Week 52
Hide Description Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (LOCF)
Arm/Group Title Placebo Linagliptin 5 mg
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed 617 618
Mean (Standard Error)
Unit of Measure: Percentage
0.05  (0.08) -0.48  (0.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Linagliptin 5 mg
Comments [Not Specified]
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 -0.53
Confidence Interval 95%
-0.64 to -0.43
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.05
Estimation Comments Linagliptin 5mg - Placebo
10.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment
Hide Description Means adjusted for treatment, baseline HbA1c, baseline FPG, categorical renal function impairment and concomitant OADs
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (LOCF), further restricted to patients with a baseline FPG measurement and at least one on-treatment FPG measurement
Arm/Group Title Placebo Linagliptin 5 mg
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed 609 614
Mean (Standard Error)
Unit of Measure: mg/dL
4.52  (3.94) -7.09  (3.97)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Linagliptin 5 mg
Comments [Not Specified]
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 -11.60
Confidence Interval 95%
-16.49 to -6.71
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.49
Estimation Comments Linagliptin 5mg - Placebo
11.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment
Hide Description [Not Specified]
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (LOCF), further restricted to patients with a baseline FPG measurement and at least one on-treatment FPG measurement
Arm/Group Title Placebo Linagliptin 5 mg
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed 609 614
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.63  (56.44) -2.55  (55.01)
12.Secondary Outcome
Title Change From Baseline in FPG
Hide Description [Not Specified]
Time Frame Baseline, 6, 12, 18, 24, 32 and 40 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS, observed cases (OC)
Arm/Group Title Placebo Linagliptin 5 mg
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed 600 606
Mean (Standard Deviation)
Unit of Measure: mg/dL
after 6 weeks of treatment 2.97  (50.89) -5.29  (44.74)
after 12 weeks of treatment (N=556, N=590) -0.33  (51.09) -7.59  (48.50)
after 18 weeks of treatment (N=533, N=567) 2.10  (53.21) -3.30  (55.51)
after 24 weeks of treatment (N=499, N=533) 0.04  (54.94) -7.07  (44.70)
after 32 weeks of treatment (N=436, N=491) -2.67  (52.43) -6.30  (48.16)
after 40 weeks of treatment (N=357, N=429) -3.99  (50.29) -6.50  (50.00)
13.Secondary Outcome
Title Change From Baseline in Mean Insulin Dose at 52 Weeks of Treatment
Hide Description Means adjusted for treatment, continous baseline HbA1c, continous baseline weight, continous baseline Insulin, categorical renal function impairment and concomitant OADs
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (LOCF)
Arm/Group Title Placebo Linagliptin 5 mg
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed 617 618
Mean (Standard Error)
Unit of Measure: International units (IU)
4.18  (0.84) 2.60  (0.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Linagliptin 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0029
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.58
Confidence Interval 95%
-2.61 to -0.54
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.53
Estimation Comments Linagliptin 5mg - Placebo
14.Secondary Outcome
Title Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment
Hide Description Mean Daily Glucose was calculated using the 8-point blood glucose profile
Time Frame Baseline, 24 and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (OC)
Arm/Group Title Placebo Linagliptin 5 mg
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed 55 52
Mean (Standard Deviation)
Unit of Measure: mmol*hr/L
after 24 weeks of treatment 0.03  (2.28) -0.01  (1.98)
after 52 weeks of treatment (N=25, N=15) 0.10  (3.06) -0.50  (2.35)
15.Secondary Outcome
Title Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment
Hide Description [Not Specified]
Time Frame Baseline and 24 weeks: post-breakfast, post-lunch, post-dinner
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (OC)
Arm/Group Title Placebo Linagliptin 5 mg
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed 60 61
Mean (Standard Deviation)
Unit of Measure: mmol*hr/L
post-breakfast incremental glucose 9.31  (44.02) -3.78  (63.63)
post-lunch incremental glucose (N=34, N=41) -17.80  (61.94) -11.00  (68.04)
post-dinner incremental glucose (N=46, N=57) -1.71  (68.15) -3.26  (66.51)
16.Other Pre-specified Outcome
Title Number of Patients With HbA1c < 6.5 Percent
Hide Description [Not Specified]
Time Frame 24 and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (NCF)
Arm/Group Title Placebo Linagliptin 5 mg
Hide Arm/Group Description:
Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
Overall Number of Participants Analyzed 617 618
Measure Type: Number
Unit of Measure: Participants
after 24 weeks of treatment 10 50
after 52 weeks of treatment 12 46
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Linagliptin 5 mg
Comments FAS with baseline HbA1c >= 6.5 percent (NCF); there are 615 available values for Placebo and 616 for Linagliptin 5mg
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 Logistic regression of HbA1c < 6.5 percent at week 52
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.327
Confidence Interval 95%
2.221 to 8.430
Estimation Comments Linagliptin 5mg vs. Placebo OR adjusted for baseline HbA1c, categorical renal function impairment, concomitant OADs and treatment
Time Frame 52 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Linagliptin 5 mg
Hide Arm/Group Description Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted. Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
All-Cause Mortality
Placebo Linagliptin 5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Linagliptin 5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   83/630 (13.17%)   87/631 (13.79%) 
Blood and lymphatic system disorders     
Anaemia  1  1/630 (0.16%)  0/631 (0.00%) 
Iron deficiency anaemia  1  1/630 (0.16%)  0/631 (0.00%) 
Pancytopenia  1  1/630 (0.16%)  0/631 (0.00%) 
Cardiac disorders     
Acute coronary syndrome  1  1/630 (0.16%)  1/631 (0.16%) 
Acute myocardial infarction  1  0/630 (0.00%)  2/631 (0.32%) 
Angina pectoris  1  1/630 (0.16%)  2/631 (0.32%) 
Angina unstable  1  1/630 (0.16%)  3/631 (0.48%) 
Arteriosclerosis coronary artery  1  1/630 (0.16%)  1/631 (0.16%) 
Atrial fibrillation  1  1/630 (0.16%)  1/631 (0.16%) 
Cardiac failure  1  2/630 (0.32%)  3/631 (0.48%) 
Cardiac failure congestive  1  2/630 (0.32%)  1/631 (0.16%) 
Cardiogenic shock  1  0/630 (0.00%)  1/631 (0.16%) 
Coronary artery disease  1  3/630 (0.48%)  2/631 (0.32%) 
Coronary artery occlusion  1  1/630 (0.16%)  1/631 (0.16%) 
Coronary artery stenosis  1  1/630 (0.16%)  1/631 (0.16%) 
Myocardial infarction  1  1/630 (0.16%)  1/631 (0.16%) 
Myocardial ischaemia  1  2/630 (0.32%)  1/631 (0.16%) 
Silent myocardial infarction  1  0/630 (0.00%)  1/631 (0.16%) 
Sinus tachycardia  1  1/630 (0.16%)  0/631 (0.00%) 
Endocrine disorders     
Hyperthyroidism  1  0/630 (0.00%)  1/631 (0.16%) 
Eye disorders     
Cataract  1  0/630 (0.00%)  2/631 (0.32%) 
Diplopia  1  1/630 (0.16%)  1/631 (0.16%) 
Retinal detachment  1  1/630 (0.16%)  0/631 (0.00%) 
Retinopathy proliferative  1  1/630 (0.16%)  0/631 (0.00%) 
Vitreous adhesions  1  0/630 (0.00%)  1/631 (0.16%) 
Vitreous haemorrhage  1  0/630 (0.00%)  1/631 (0.16%) 
Gastrointestinal disorders     
Abdominal hernia  1  1/630 (0.16%)  0/631 (0.00%) 
Abdominal pain  1  0/630 (0.00%)  1/631 (0.16%) 
Abdominal pain lower  1  1/630 (0.16%)  0/631 (0.00%) 
Diverticulum intestinal haemorrhagic  1  1/630 (0.16%)  1/631 (0.16%) 
Duodenal ulcer  1  0/630 (0.00%)  1/631 (0.16%) 
Gastric ulcer  1  1/630 (0.16%)  2/631 (0.32%) 
Gastritis erosive  1  0/630 (0.00%)  1/631 (0.16%) 
Mallory-Weiss syndrome  1  0/630 (0.00%)  1/631 (0.16%) 
Megacolon  1  0/630 (0.00%)  1/631 (0.16%) 
Nausea  1  1/630 (0.16%)  0/631 (0.00%) 
Oesophageal varices haemorrhage  1  0/630 (0.00%)  1/631 (0.16%) 
Pancreatitis  1  1/630 (0.16%)  1/631 (0.16%) 
Pancreatitis chronic  1  0/630 (0.00%)  1/631 (0.16%) 
Umbilical hernia  1  1/630 (0.16%)  0/631 (0.00%) 
Upper gastrointestinal haemorrhage  1  0/630 (0.00%)  1/631 (0.16%) 
Vomiting  1  1/630 (0.16%)  1/631 (0.16%) 
General disorders     
Chest pain  1  1/630 (0.16%)  1/631 (0.16%) 
Death  1  1/630 (0.16%)  0/631 (0.00%) 
Non-cardiac chest pain  1  1/630 (0.16%)  0/631 (0.00%) 
Pyrexia  1  1/630 (0.16%)  0/631 (0.00%) 
Sudden death  1  0/630 (0.00%)  2/631 (0.32%) 
Hepatobiliary disorders     
Cholecystitis acute  1  1/630 (0.16%)  1/631 (0.16%) 
Cholelithiasis  1  0/630 (0.00%)  1/631 (0.16%) 
Hepatic cyst  1  0/630 (0.00%)  1/631 (0.16%) 
Infections and infestations     
Appendicitis perforated  1  1/630 (0.16%)  0/631 (0.00%) 
Beta haemolytic streptococcal infection  1  1/630 (0.16%)  0/631 (0.00%) 
Bronchitis  1  0/630 (0.00%)  2/631 (0.32%) 
Bronchopneumonia  1  1/630 (0.16%)  0/631 (0.00%) 
Cellulitis  1  1/630 (0.16%)  0/631 (0.00%) 
Cellulitis of male external genital organ  1  1/630 (0.16%)  0/631 (0.00%) 
Clostridium difficile colitis  1  1/630 (0.16%)  0/631 (0.00%) 
Erysipelas  1  2/630 (0.32%)  1/631 (0.16%) 
Gangrene  1  1/630 (0.16%)  0/631 (0.00%) 
Gastroenteritis  1  2/630 (0.32%)  2/631 (0.32%) 
Infected skin ulcer  1  0/630 (0.00%)  1/631 (0.16%) 
Influenza  1  1/630 (0.16%)  0/631 (0.00%) 
Localised infection  1  0/630 (0.00%)  1/631 (0.16%) 
Meningitis streptococcal  1  1/630 (0.16%)  0/631 (0.00%) 
Orchitis  1  1/630 (0.16%)  0/631 (0.00%) 
Osteomyelitis  1  1/630 (0.16%)  0/631 (0.00%) 
Pneumonia  1  4/630 (0.63%)  3/631 (0.48%) 
Pneumonia staphylococcal  1  0/630 (0.00%)  1/631 (0.16%) 
Staphylococcal infection  1  0/630 (0.00%)  1/631 (0.16%) 
Streptococcal infection  1  0/630 (0.00%)  1/631 (0.16%) 
Upper respiratory tract infection  1  0/630 (0.00%)  1/631 (0.16%) 
Urinary tract infection  1  2/630 (0.32%)  1/631 (0.16%) 
Urosepsis  1  1/630 (0.16%)  0/631 (0.00%) 
Injury, poisoning and procedural complications     
Alcohol poisoning  1  0/630 (0.00%)  1/631 (0.16%) 
Ankle fracture  1  2/630 (0.32%)  0/631 (0.00%) 
Contusion  1  0/630 (0.00%)  2/631 (0.32%) 
Electric shock  1  0/630 (0.00%)  1/631 (0.16%) 
Excoriation  1  0/630 (0.00%)  1/631 (0.16%) 
Fall  1  4/630 (0.63%)  3/631 (0.48%) 
Fibula fracture  1  0/630 (0.00%)  1/631 (0.16%) 
Fractured ischium  1  0/630 (0.00%)  1/631 (0.16%) 
Head injury  1  1/630 (0.16%)  0/631 (0.00%) 
Joint sprain  1  0/630 (0.00%)  1/631 (0.16%) 
Laceration  1  1/630 (0.16%)  0/631 (0.00%) 
Ligament injury  1  0/630 (0.00%)  1/631 (0.16%) 
Lower limb fracture  1  0/630 (0.00%)  1/631 (0.16%) 
Meniscus lesion  1  1/630 (0.16%)  0/631 (0.00%) 
Muscle injury  1  1/630 (0.16%)  1/631 (0.16%) 
Muscle rupture  1  0/630 (0.00%)  1/631 (0.16%) 
Muscle strain  1  1/630 (0.16%)  0/631 (0.00%) 
Pelvic fracture  1  0/630 (0.00%)  1/631 (0.16%) 
Road traffic accident  1  1/630 (0.16%)  2/631 (0.32%) 
Scapula fracture  1  1/630 (0.16%)  0/631 (0.00%) 
Subdural haematoma  1  1/630 (0.16%)  2/631 (0.32%) 
Tendon rupture  1  1/630 (0.16%)  0/631 (0.00%) 
Tibia fracture  1  1/630 (0.16%)  1/631 (0.16%) 
Toxicity to various agents  1  0/630 (0.00%)  1/631 (0.16%) 
Wrist fracture  1  1/630 (0.16%)  1/631 (0.16%) 
Investigations     
Blood creatine phosphokinase increased  1  0/630 (0.00%)  1/631 (0.16%) 
Colonoscopy  1  0/630 (0.00%)  1/631 (0.16%) 
Metabolism and nutrition disorders     
Dehydration  1  0/630 (0.00%)  1/631 (0.16%) 
Diabetes mellitus  1  1/630 (0.16%)  0/631 (0.00%) 
Hyperglycaemia  1  2/630 (0.32%)  0/631 (0.00%) 
Hypoglycaemia  1  1/630 (0.16%)  3/631 (0.48%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/630 (0.00%)  1/631 (0.16%) 
Flank pain  1  0/630 (0.00%)  1/631 (0.16%) 
Musculoskeletal chest pain  1  1/630 (0.16%)  0/631 (0.00%) 
Musculoskeletal pain  1  1/630 (0.16%)  0/631 (0.00%) 
Neck pain  1  0/630 (0.00%)  1/631 (0.16%) 
Osteoarthritis  1  3/630 (0.48%)  2/631 (0.32%) 
Osteolysis  1  1/630 (0.16%)  0/631 (0.00%) 
Spinal column stenosis  1  1/630 (0.16%)  0/631 (0.00%) 
Tendonitis  1  0/630 (0.00%)  1/631 (0.16%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bile duct cancer  1  0/630 (0.00%)  1/631 (0.16%) 
Colon cancer  1  0/630 (0.00%)  1/631 (0.16%) 
Gastric cancer  1  0/630 (0.00%)  1/631 (0.16%) 
Hepatic neoplasm malignant  1  1/630 (0.16%)  0/631 (0.00%) 
Leiomyosarcoma metastatic  1  1/630 (0.16%)  0/631 (0.00%) 
Lung adenocarcinoma  1  1/630 (0.16%)  1/631 (0.16%) 
Non-small cell lung cancer metastatic  1  2/630 (0.32%)  0/631 (0.00%) 
Ovarian adenoma  1  1/630 (0.16%)  2/631 (0.32%) 
Renal cancer  1  1/630 (0.16%)  0/631 (0.00%) 
Squamous cell carcinoma  1  0/630 (0.00%)  1/631 (0.16%) 
Uterine cancer  1  0/630 (0.00%)  1/631 (0.16%) 
Uterine leiomyoma  1  0/630 (0.00%)  1/631 (0.16%) 
Nervous system disorders     
Cerebrovascular accident  1  0/630 (0.00%)  2/631 (0.32%) 
Cerebrovascular disorder  1  1/630 (0.16%)  0/631 (0.00%) 
Cranial nerve paralysis  1  0/630 (0.00%)  1/631 (0.16%) 
Dizziness  1  0/630 (0.00%)  1/631 (0.16%) 
Embolic stroke  1  1/630 (0.16%)  0/631 (0.00%) 
Haemorrhagic stroke  1  1/630 (0.16%)  1/631 (0.16%) 
Ischaemic stroke  1  2/630 (0.32%)  0/631 (0.00%) 
Loss of consciousness  1  0/630 (0.00%)  1/631 (0.16%) 
Syncope  1  1/630 (0.16%)  0/631 (0.00%) 
Transient ischaemic attack  1  0/630 (0.00%)  1/631 (0.16%) 
Psychiatric disorders     
Alcohol abuse  1  1/630 (0.16%)  0/631 (0.00%) 
Depression  1  1/630 (0.16%)  0/631 (0.00%) 
Mental disorder due to a general medical condition  1  1/630 (0.16%)  0/631 (0.00%) 
Suicide attempt  1  0/630 (0.00%)  1/631 (0.16%) 
Renal and urinary disorders     
Calculus ureteric  1  0/630 (0.00%)  1/631 (0.16%) 
Glomerulonephritis  1  1/630 (0.16%)  0/631 (0.00%) 
Haematuria  1  0/630 (0.00%)  1/631 (0.16%) 
Hydronephrosis  1  1/630 (0.16%)  0/631 (0.00%) 
Nephrolithiasis  1  0/630 (0.00%)  2/631 (0.32%) 
Renal colic  1  1/630 (0.16%)  1/631 (0.16%) 
Renal failure acute  1  3/630 (0.48%)  0/631 (0.00%) 
Renal failure chronic  1  1/630 (0.16%)  0/631 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/630 (0.16%)  0/631 (0.00%) 
Penile pain  1  1/630 (0.16%)  0/631 (0.00%) 
Prostatitis  1  1/630 (0.16%)  0/631 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  1/630 (0.16%)  0/631 (0.00%) 
Asthma  1  1/630 (0.16%)  0/631 (0.00%) 
Asthmatic crisis  1  0/630 (0.00%)  1/631 (0.16%) 
Atelectasis  1  0/630 (0.00%)  1/631 (0.16%) 
Chronic obstructive pulmonary disease  1  1/630 (0.16%)  1/631 (0.16%) 
Dyspnoea  1  1/630 (0.16%)  0/631 (0.00%) 
Nasal polyps  1  1/630 (0.16%)  0/631 (0.00%) 
Organising pneumonia  1  1/630 (0.16%)  0/631 (0.00%) 
Pulmonary embolism  1  1/630 (0.16%)  0/631 (0.00%) 
Pulmonary oedema  1  1/630 (0.16%)  0/631 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin ulcer  1  0/630 (0.00%)  1/631 (0.16%) 
Surgical and medical procedures     
Ureteral catheterisation  1  1/630 (0.16%)  0/631 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  0/630 (0.00%)  1/631 (0.16%) 
Embolism  1  0/630 (0.00%)  1/631 (0.16%) 
Extremity necrosis  1  0/630 (0.00%)  1/631 (0.16%) 
Hypertensive crisis  1  2/630 (0.32%)  0/631 (0.00%) 
Hypotension  1  1/630 (0.16%)  0/631 (0.00%) 
Intermittent claudication  1  1/630 (0.16%)  0/631 (0.00%) 
Lymphoedema  1  1/630 (0.16%)  0/631 (0.00%) 
Peripheral ischaemia  1  0/630 (0.00%)  1/631 (0.16%) 
Venous thrombosis limb  1  1/630 (0.16%)  0/631 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Linagliptin 5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   354/630 (56.19%)   354/631 (56.10%) 
Gastrointestinal disorders     
Diarrhoea  1  30/630 (4.76%)  33/631 (5.23%) 
Infections and infestations     
Influenza  1  33/630 (5.24%)  26/631 (4.12%) 
Nasopharyngitis  1  62/630 (9.84%)  71/631 (11.25%) 
Urinary tract infection  1  43/630 (6.83%)  30/631 (4.75%) 
Metabolism and nutrition disorders     
Hyperglycaemia  1  112/630 (17.78%)  90/631 (14.26%) 
Hypoglycaemia  1  197/630 (31.27%)  191/631 (30.27%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  30/630 (4.76%)  34/631 (5.39%) 
Nervous system disorders     
Dizziness  1  30/630 (4.76%)  33/631 (5.23%) 
Headache  1  27/630 (4.29%)  35/631 (5.55%) 
Vascular disorders     
Hypertension  1  35/630 (5.56%)  30/631 (4.75%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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
ClinicalTrials.gov Identifier: NCT00954447    
Other Study ID Numbers: 1218.36
2008-008296-33 ( EudraCT Number: EudraCT )
First Submitted: August 6, 2009
First Posted: August 7, 2009
Results First Submitted: August 28, 2012
Results First Posted: September 27, 2012
Last Update Posted: December 30, 2013