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Linagliptin 2.5 mg Twice Daily Versus 5 mg Once Daily as add-on Therapy to Twice Daily Metformin in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01012037
First received: November 10, 2009
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
Results First Received: September 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: linagliptin low dose
Drug: placebo
Drug: linagliptin medium dose

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Patients treated with matching placebo
Lina 2.5 Twice Daily (Bid) Patients treated with Linagliptin 2.5mg bid
Lina 5 Once Daily (qd) Patients treated with Linagliptin 5mg qd

Participant Flow:   Overall Study
    Placebo     Lina 2.5 Twice Daily (Bid)     Lina 5 Once Daily (qd)  
STARTED     44     223     224  
COMPLETED     43     207     214  
NOT COMPLETED     1     16     10  
Adverse Event                 0                 8                 3  
Protocol Violation                 0                 3                 5  
Withdrawal by Subject                 0                 4                 1  
Other reason (not specified)                 1                 1                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Placebo Patients treated with matching placebo
Lina 2.5 Twice Daily (Bid) Patients treated with Linagliptin 2.5mg bid
Lina 5 Once Daily (qd) Patients treated with Linagliptin 5mg qd
Total Total of all reporting groups

Baseline Measures
    Placebo     Lina 2.5 Twice Daily (Bid)     Lina 5 Once Daily (qd)     Total  
Number of Participants  
[units: participants]
 		  44     223     224     491  
Age  
[units: Years]
Mean ± Standard Deviation 		  59.9  ± 10.7     58.7  ± 9.9     58.4  ± 10.6     58.6  ± 10.3  
Gender  
[units: Patients]
 		       
Female     23     85     103     211  
Male     21     138     121     280  
Body Mass Index (BMI) continuous  
[units: kg/m^2]
Mean ± Standard Deviation 		  28.65  ± 5.53     29.77  ± 5.23     29.55  ± 4.95     29.57  ± 5.13  
Glycosylated hemoglobin (HbA1c) [1]
[units: percent]
Mean ± Standard Deviation 		  7.92  ± 0.74     7.96  ± 0.78     7.98  ± 0.72     7.97  ± 0.75  
Fasting blood plasma glucose (FPG) [2]
[units: mg/dL]
Mean ± Standard Deviation 		  166.2  ± 40.3     164.1  ± 41.8     165.8  ± 35.1     165.1  ± 38.6  
[1] Baseline HbA1c was determined for the Full Analysis Set with 43 patients treated with Placebo, 214 patients treated with Linagliptin 2.5 bid and 221 patients treated with Linagliptin 5mg qd (478 in total).
[2] Baseline FPG was determined for the Full Analysis Set (where FPG values were also available) with 41 patients treated with Placebo, 209 patients treated with Linagliptin 2.5 bid and 216 patients treated with Linagliptin 5mg qd (466 in total).



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   HbA1c Change From Baseline at Week 12   [ Time Frame: Baseline and week 12 ]

Measure Type Primary
Measure Title HbA1c Change From Baseline at Week 12
Measure Description HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Treatment means are adjusted for baseline HbA1c and use of prior oral antidiabetics (OADs) in addition to background metformin.
Time Frame Baseline and week 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set (FAS) included all 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.

Reporting Groups
  Description
Placebo Patients treated with matching placebo
Lina 2.5 Twice Daily (Bid) Patients treated with Linagliptin 2.5mg bid
Lina 5 Once Daily (qd) Patients treated with Linagliptin 5mg qd

Measured Values
    Placebo     Lina 2.5 Twice Daily (Bid)     Lina 5 Once Daily (qd)  
Number of Participants Analyzed  
[units: participants]
 		  43     214     221  
HbA1c Change From Baseline at Week 12  
[units: percent]
Mean ± Standard Error 		  0.28  ± 0.11     -0.46  ± 0.05     -0.52  ± 0.05  


Statistical Analysis 1 for HbA1c Change From Baseline at Week 12
Groups [1] Placebo vs. Lina 2.5 Twice Daily (Bid)
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Final Values) [4] -0.74
Standard Error of the mean ± 0.11
95% Confidence Interval ( -0.97 to -0.52 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin 2.5mg bid versus Placebo
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for HbA1c Change From Baseline at Week 12
Groups [1] Placebo vs. Lina 5 Once Daily (qd)
Method [2] ANCOVA
P Value [3] <0.0001
Mean Difference (Final Values) [4] -0.80
Standard Error of the mean ± 0.11
95% Confidence Interval ( -1.02 to -0.58 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin 5mg qd versus Placebo
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for HbA1c Change From Baseline at Week 12
Groups [1] Lina 2.5 Twice Daily (Bid) vs. Lina 5 Once Daily (qd)
Non-Inferiority/Equivalence Test [2] Yes
Mean Difference (Final Values) [3] 0.06
Standard Error of the mean ± 0.07
95% Confidence Interval ( -0.07 to 0.19 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin 2.5mg bid versus Linagliptin 5mg qd
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  The pre-defined non-inferiority margin was +0.35
[3] Other relevant estimation information:
  No text entered.



2.  Secondary:   HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis   [ Time Frame: Baseline and week 6 ]

Measure Type Secondary
Measure Title HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis
Measure Description Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
Time Frame Baseline and week 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. No imputation was performed. Patients without a Week 6 value were handled by the statistical model.

Reporting Groups
  Description
Placebo Patients treated with matching placebo
Lina 2.5 Twice Daily (Bid) Patients treated with Linagliptin 2.5mg bid
Lina 5 Once Daily (qd) Patients treated with Linagliptin 5mg qd

Measured Values
    Placebo     Lina 2.5 Twice Daily (Bid)     Lina 5 Once Daily (qd)  
Number of Participants Analyzed  
[units: participants]
 		  43     214     221  
HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis  
[units: percent]
Mean ± Standard Error 		  0.32  ± 0.08     -0.34  ± 0.04     -0.34  ± 0.04  


Statistical Analysis 1 for HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis
Groups [1] Placebo vs. Lina 2.5 Twice Daily (Bid)
Method [2] Mixed Models Analysis
P Value [3] <0.0001
Mean Difference (Final Values) [4] -0.66
Standard Error of the mean ± 0.09
95% Confidence Interval ( -0.83 to -0.48 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin 2.5mg bid versus Placebo
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis
Groups [1] Placebo vs. Lina 5 Once Daily (qd)
Method [2] Mixed Models Analysis
P Value [3] <0.0001
Mean Difference (Final Values) [4] -0.66
Standard Error of the mean ± 0.09
95% Confidence Interval ( -0.84 to -0.49 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin 5mg qd versus Placebo
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis
Groups [1] Lina 2.5 Twice Daily (Bid) vs. Lina 5 Once Daily (qd)
Non-Inferiority/Equivalence Test [2] Yes
Mean Difference (Final Values) [3] 0.00
Standard Error of the mean ± 0.05
95% Confidence Interval ( -0.10 to 0.10 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin 2.5mg bid versus Linagliptin 5mg qd
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  The pre-defined non-inferiority margin was +0.35
[3] Other relevant estimation information:
  No text entered.



3.  Secondary:   HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis   [ Time Frame: Baseline and week 12 ]

Measure Type Secondary
Measure Title HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis
Measure Description Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
Time Frame Baseline and week 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. No imputation was performed. Patients without a Week 12 value were handled by the statistical model.

Reporting Groups
  Description
Placebo Patients treated with matching placebo
Lina 2.5 Twice Daily (Bid) Patients treated with Linagliptin 2.5mg bid
Lina 5 Once Daily (qd) Patients treated with Linagliptin 5mg qd

Measured Values
    Placebo     Lina 2.5 Twice Daily (Bid)     Lina 5 Once Daily (qd)  
Number of Participants Analyzed  
[units: participants]
 		  43     214     221  
HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis  
[units: percent]
Mean ± Standard Error 		  0.27  ± 0.11     -0.51  ± 0.05     -0.55  ± 0.05  


Statistical Analysis 1 for HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis
Groups [1] Placebo vs. Lina 2.5 Twice Daily (Bid)
Method [2] Mixed Models Analysis
P Value [3] <0.0001
Mean Difference (Final Values) [4] -0.77
Standard Error of the mean ± 0.12
95% Confidence Interval ( -1.00 to -0.54 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin 2.5mg bid versus Placebo
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis
Groups [1] Placebo vs. Lina 5 Once Daily (qd)
Method [2] Mixed Models Analysis
P Value [3] <0.0001
Mean Difference (Final Values) [4] -0.82
Standard Error of the mean ± 0.12
95% Confidence Interval ( -1.05 to -0.59 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin 5mg qd versus Placebo
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis
Groups [1] Lina 2.5 Twice Daily (Bid) vs. Lina 5 Once Daily (qd)
Non-Inferiority/Equivalence Test [2] Yes
Mean Difference (Final Values) [3] 0.05
Standard Error of the mean ± 0.07
95% Confidence Interval ( -0.08 to 0.18 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin 2.5mg bid versus Linagliptin 5mg qd
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  The pre-defined non-inferiority margin was +0.35
[3] Other relevant estimation information:
  No text entered.



4.  Secondary:   FPG Change From Baseline at Week 12   [ Time Frame: Baseline and week 12 ]

Measure Type Secondary
Measure Title FPG Change From Baseline at Week 12
Measure Description Change from baseline reflects the Week 12 FPG minus the baseline FPG. Treatment means are adjusted for baseline HbA1c, baseline fasting plasma glucose and use of prior oral antidiabetics (OADs) in addition to background metformin.
Time Frame Baseline and week 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients from FAS with values for FPG at baseline and on-treatment. Last observation carried forward (LOCF) was used as the imputation rule.

Reporting Groups
  Description
Placebo Patients treated with matching placebo
Lina 2.5 Twice Daily (Bid) Patients treated with Linagliptin 2.5mg bid
Lina 5 Once Daily (qd) Patients treated with Linagliptin 5mg qd

Measured Values
    Placebo     Lina 2.5 Twice Daily (Bid)     Lina 5 Once Daily (qd)  
Number of Participants Analyzed  
[units: participants]
 		  40     203     213  
FPG Change From Baseline at Week 12  
[units: mg/dL]
Mean ± Standard Error 		  -3.5  ± 4.2     -17.2  ± 1.9     -21.3  ± 1.9  


Statistical Analysis 1 for FPG Change From Baseline at Week 12
Groups [1] Placebo vs. Lina 2.5 Twice Daily (Bid)
Method [2] ANCOVA
P Value [3] 0.0029
Mean Difference (Final Values) [4] -13.7
Standard Error of the mean ± 4.6
95% Confidence Interval ( -22.7 to -4.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin 2.5mg bid versus Placebo
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for FPG Change From Baseline at Week 12
Groups [1] Placebo vs. Lina 5 Once Daily (qd)
Method [2] ANCOVA
P Value [3] 0.0001
Mean Difference (Final Values) [4] -17.8
Standard Error of the mean ± 4.6
95% Confidence Interval ( -26.7 to -8.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin 5 mg qd versus Placebo
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for FPG Change From Baseline at Week 12
Groups [1] Lina 2.5 Twice Daily (Bid) vs. Lina 5 Once Daily (qd)
Mean Difference (Final Values) [2] 4.1
Standard Error of the mean ± 2.6
95% Confidence Interval ( -1.0 to 9.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin 2.5mg bid versus Linagliptin 5mg qd
[2] Other relevant estimation information:
  No non-inferiority margin was pre-defined for FPG



5.  Secondary:   FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis   [ Time Frame: Baseline and week 6 ]

Measure Type Secondary
Measure Title FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis
Measure Description Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
Time Frame Baseline and week 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients from FAS with values for FPG at baseline and on-treatment. No imputation was performed. Patients without a Week 12 value were handled by the statistical model.

Reporting Groups
  Description
Placebo Patients treated with matching placebo
Lina 2.5 Twice Daily (Bid) Patients treated with Linagliptin 2.5mg bid
Lina 5 Once Daily (qd) Patients treated with Linagliptin 5mg qd

Measured Values
    Placebo     Lina 2.5 Twice Daily (Bid)     Lina 5 Once Daily (qd)  
Number of Participants Analyzed  
[units: participants]
 		  40     203     213  
FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis  
[units: percent]
Mean ± Standard Error 		  -1.2  ± 4.1     -17.8  ± 1.9     -20.1  ± 1.8  


Statistical Analysis 1 for FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis
Groups [1] Placebo vs. Lina 2.5 Twice Daily (Bid)
Method [2] Mixed Models Analysis
P Value [3] 0.0002
Mean Difference (Final Values) [4] -16.6
Standard Error of the mean ± 4.4
95% Confidence Interval ( -25.3 to -7.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin 2.5mg bid versus Placebo
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis
Groups [1] Placebo vs. Lina 5 Once Daily (qd)
Method [2] Mixed Models Analysis
P Value [3] <0.0001
Mean Difference (Final Values) [4] -18.9
Standard Error of the mean ± 4.4
95% Confidence Interval ( -27.6 to -10.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin 5mg qd versus Placebo
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis
Groups [1] Lina 2.5 Twice Daily (Bid) vs. Lina 5 Once Daily (qd)
Mean Difference (Final Values) [2] 2.3
Standard Error of the mean ± 2.5
95% Confidence Interval ( -2.6 to 7.3 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin 2.5mg bid versus Linagliptin 5mg qd
[2] Other relevant estimation information:
  No non-inferiority margin was pre-defined for FPG



6.  Secondary:   FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis   [ Time Frame: Baseline and week 12 ]

Measure Type Secondary
Measure Title FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis
Measure Description Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.
Time Frame Baseline and week 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients from FAS with values for FPG at baseline and on-treatment. No imputation was performed. Patients without a Week 12 value were handled by the statistical model.

Reporting Groups
  Description
Placebo Patients treated with matching placebo
Lina 2.5 Twice Daily (Bid) Patients treated with Linagliptin 2.5mg bid
Lina 5 Once Daily (qd) Patients treated with Linagliptin 5mg qd

Measured Values
    Placebo     Lina 2.5 Twice Daily (Bid)     Lina 5 Once Daily (qd)  
Number of Participants Analyzed  
[units: participants]
 		  40     203     213  
FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis  
[units: percent]
Mean ± Standard Error 		  -8.7  ± 5.0     -18.7  ± 2.3     -23.9  ± 2.2  


Statistical Analysis 1 for FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis
Groups [1] Placebo vs. Lina 2.5 Twice Daily (Bid)
Method [2] Mixed Models Analysis
P Value [3] 0.0653
Mean Difference (Final Values) [4] -10.0
Standard Error of the mean ± 5.4
95% Confidence Interval ( -20.6 to 0.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin 2.5mg bid versus Placebo
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis
Groups [1] Placebo vs. Lina 5 Once Daily (qd)
Method [2] Mixed Models Analysis
P Value [3] 0.0047
Mean Difference (Final Values) [4] -15.3
Standard Error of the mean ± 5.4
95% Confidence Interval ( -25.8 to -4.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin 5mg qd versus Placebo
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis
Groups [1] Lina 2.5 Twice Daily (Bid) vs. Lina 5 Once Daily (qd)
Mean Difference (Final Values) [2] 5.3
Standard Error of the mean ± 3.0
95% Confidence Interval ( -0.7 to 11.3 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin 2.5mg bid versus Linagliptin 5mg qd
[2] Other relevant estimation information:
  No non-inferiority margin was pre-defined for FPG



7.  Secondary:   Percentage of Patients With HbA1c Lowering by 0.5% or More at Week 12   [ Time Frame: Week 12 ]

Measure Type Secondary
Measure Title Percentage of Patients With HbA1c Lowering by 0.5% or More at Week 12
Measure Description No text entered.
Time Frame Week 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. Patients without a value at Week 12 were analysed as non-responders

Reporting Groups
  Description
Placebo Patients treated with matching placebo
Lina 2.5 Twice Daily (Bid) Patients treated with Linagliptin 2.5mg bid
Lina 5 Once Daily (qd) Patients treated with Linagliptin 5mg qd

Measured Values
    Placebo     Lina 2.5 Twice Daily (Bid)     Lina 5 Once Daily (qd)  
Number of Participants Analyzed  
[units: participants]
 		  43     214     221  
Percentage of Patients With HbA1c Lowering by 0.5% or More at Week 12  
[units: percent]
 		  16.3     55.1     59.7  

No statistical analysis provided for Percentage of Patients With HbA1c Lowering by 0.5% or More at Week 12



8.  Secondary:   Percentage of Patients With Rescue Therapy   [ Time Frame: 12 weeks ]

Measure Type Secondary
Measure Title Percentage of Patients With Rescue Therapy
Measure Description No text entered.
Time Frame 12 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Patients treated with matching placebo
Lina 2.5 Twice Daily (Bid) Patients treated with Linagliptin 2.5mg bid
Lina 5 Once Daily (qd) Patients treated with Linagliptin 5mg qd

Measured Values
    Placebo     Lina 2.5 Twice Daily (Bid)     Lina 5 Once Daily (qd)  
Number of Participants Analyzed  
[units: participants]
 		  43     214     221  
Percentage of Patients With Rescue Therapy  
[units: percent]
 		  7.0     3.7     1.8  

No statistical analysis provided for Percentage of Patients With Rescue Therapy




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  Other Adverse Events
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided by Boehringer Ingelheim Pharmaceuticals

Publications automatically indexed to this study:


Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01012037     History of Changes
Other Study ID Numbers: 1218.62, 2009-013549-27
Study First Received: November 10, 2009
Results First Received: September 21, 2011
Last Updated: May 18, 2012
Health Authority: Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
India: Drugs Controller General of India
Italy: Ethics Committee
Malaysia: Ministry of Health
Netherlands: Central Committee Research Involving Human Subjects
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Ministry of Health