Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00622284
First received: February 13, 2008
Last updated: December 11, 2013
Last verified: December 2013
Results First Received: November 30, 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: Placebo identical to BI 1356 5mg
Drug: Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg
Drug: BI 1356
Drug: Glimepiride

  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
There were in total 1560 patients randomised in the study. Of these, 1 patient was not treated. The remaining 8 patients not accounted for in the treated set were removed from all study analyses (explained in trial report) due to major good-clinical-practice violations at the site, and the inability to verify the validity of any patient level data.

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
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Participant Flow:   Overall Study
    Linagliptin     Glimepiride  
STARTED     776 [1]   775 [2]
COMPLETED     587 [3]   604 [3]
NOT COMPLETED     189     171  
Lack of Efficacy                 45                 15  
Adverse Event                 61                 90  
Protocol Violation                 12                 5  
Lost to Follow-up                 11                 13  
Withdrawal by Subject                 27                 24  
Other reason (not specified)                 33                 24  
[1] Number who started treatment. One patient in the Linagliptin group was randomized but not treated.
[2] Number who started treatment.
[3] Number who completed treatment.



  Baseline Characteristics
  Hide Baseline Characteristics

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
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin
Total Total of all reporting groups

Baseline Measures
    Linagliptin     Glimepiride     Total  
Number of Participants  
[units: participants]
  776     775     1551  
Age  
[units: Years]
Mean ± Standard Deviation
  59.8  ± 9.4     59.8  ± 9.4     59.8  ± 9.4  
Gender  
[units: Patients]
     
Female     314     304     618  
Male     462     471     933  
Body mass index (BMI) continuous  
[units: kg/m^2]
Mean ± Standard Deviation
  30.21  ± 4.77     30.31  ± 4.57     30.26  ± 4.67  
Weight  
[units: kg]
Mean ± Standard Deviation
  86.14  ± 17.57     86.77  ± 16.69     86.46  ± 17.14  
Glycosylated haemoglobin (HbA1c) [1]
[units: Percent]
Mean ± Standard Deviation
  7.69  ± 0.88     7.69  ± 0.86     7.69  ± 0.87  
Fasting blood plasma glucose (FPG) [2]
[units: mg/dL]
Mean ± Standard Deviation
  164.46  ± 42.83     166.09  ± 42.05     165.27  ± 42.43  
[1] Baseline HbA1c was available for 1519 patients in the Full Analysis Set (FAS), 764 treated with Linagliptin and 755 patients treated with Glimepiride.
[2] Baseline fasting plasma glucose (FPG) was available for 1475 patients in the FAS, 740 treated with Linagliptin and 735 patients treated with Glimepiride.



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   HbA1c Change From Baseline at Week 52   [ Time Frame: Baseline and week 52 ]

Measure Type Primary
Measure Title HbA1c Change From Baseline at Week 52
Measure Description This co-primary endpoint, change from baseline, reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
Time Frame Baseline and week 52  
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 and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  764     755  
HbA1c Change From Baseline at Week 52  
[units: Percent]
Mean ± Standard Error
  -0.36  ± 0.03     -0.57  ± 0.03  


Statistical Analysis 1 for HbA1c Change From Baseline at Week 52
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] ANCOVA
P Value [4] 0.0005
Least Squares Mean Difference [5] 0.22
Standard Error of the mean ± 0.04
97.5% Confidence Interval ( 0.13 to 0.31 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin versus Glimepiride
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  The null hypothesis of non-inferiority is rejected if the upper bound of the two-sided 97.5% confidence interval is less than 0.35%. Superiority testing was not part of the pre-specified Week 52 confirmatory analysis.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Due to multiple testing of the primary endpoints at weeks 52 and 104 a Bonferroni correction was applied and 97.5% confidence intervals produced. This 1-sided p-value for non-inferiority should be compared to the 1-sided threshold of 0.0125.
[5] Other relevant estimation information:
  No text entered.



2.  Primary:   HbA1c Change From Baseline at Week 104   [ Time Frame: Baseline and week 104 ]

Measure Type Primary
Measure Title HbA1c Change From Baseline at Week 104
Measure Description This co-primary endpoint, change from baseline, reflects the Week 104 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
Time Frame Baseline and week 104  
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 and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  764     755  
HbA1c Change From Baseline at Week 104  
[units: Percent]
Mean ± Standard Error
  -0.16  ± 0.03     -0.36  ± 0.03  


Statistical Analysis 1 for HbA1c Change From Baseline at Week 104
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] ANCOVA
P Value [4] 0.0004
Least Squares Mean Difference [5] 0.20
Standard Error of the mean ± 0.05
97.5% Confidence Interval ( 0.09 to 0.30 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin versus Glimepiride
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  The null hypothesis of non-inferiority is rejected if the upper bound of the two-sided 97.5% confidence interval is less than 0.35%. However, superiority testing is only applicable if the Linagliptin decrease is greater than that in Glimepiride.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  This 1-sided p-value should be compared to the 1-sided threshold of 0.0125 for non-inferiority. Due to the pre-specified hierarchial approach, further confirmatory analysis on the Week24 endpoints is only applicable if superiority is already met.
[5] Other relevant estimation information:
  No text entered.



3.  Secondary:   Body Weight Change From Baseline at Week 52   [ Time Frame: Baseline and week 52 ]

Measure Type Secondary
Measure Title Body Weight Change From Baseline at Week 52
Measure Description This key secondary endpoint, change from baseline, reflects the Week 52 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.
Time Frame Baseline and week 52  
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.
This population includes the FAS further restricted to patients with a baseline body weight and one on-treatment body weight measurement. Last observation carried forward (LOCF) was used as imputation rule.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  733     722  
Body Weight Change From Baseline at Week 52  
[units: kg]
Mean ± Standard Error
  -1.12  ± 0.13     1.38  ± 0.14  


Statistical Analysis 1 for Body Weight Change From Baseline at Week 52
Groups [1] All groups
Method [2] ANCOVA
P Value [3] <0.0001
Least Squares Mean Difference [4] -2.50
Standard Error of the mean ± 0.18
97.5% Confidence Interval ( -2.91 to -2.09 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin versus Glimepiride
[2] Other relevant method 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:
  This Week52 key secondary endpoint was only to be tested (2-sided threshold of 0.025 to allow for multiple testing within a visit) if the Week52 primary hypothesis was rejected.
[4] Other relevant estimation information:
  No text entered.



4.  Secondary:   Body Weight Change From Baseline at Week 104   [ Time Frame: Baseline and week 104 ]

Measure Type Secondary
Measure Title Body Weight Change From Baseline at Week 104
Measure Description This key secondary endpoint, change from baseline, reflects the Week 104 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.
Time Frame Baseline and week 104  
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.
This population includes the FAS further restricted to patients with a baseline body weight and one on-treatment body weight measurement. Last observation carried forward (LOCF) was used as imputation rule.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  733     722  
Body Weight Change From Baseline at Week 104  
[units: kg]
Mean ± Standard Error
  -1.39  ± 0.16     1.29  ± 0.16  


Statistical Analysis 1 for Body Weight Change From Baseline at Week 104
Groups [1] All groups
Method [2] ANCOVA
P Value [3] <0.0001
Least Squares Mean Difference [4] -2.68
Standard Error of the mean ± 0.22
97.5% Confidence Interval ( -3.17 to -2.19 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin versus Glimepiride
[2] Other relevant method 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:
  Due to testing of multiple endpoints within a visit a sequential testing strategy (at 2-sided threshold of 0.025) was applied to the key secondary endpoints.
[4] Other relevant estimation information:
  No text entered.



5.  Secondary:   Incidence of Hypoglycaemic Events up to 52 Weeks   [ Time Frame: Week 52 ]

Measure Type Secondary
Measure Title Incidence of Hypoglycaemic Events up to 52 Weeks
Measure Description A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a home blood glucose monitoring (HBGM) of below 55 mg/dl (3.1 mmol/L)
Time Frame Week 52  
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 treated set consisted of all patients treated with at least one dose of study drug

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  776     775  
Incidence of Hypoglycaemic Events up to 52 Weeks  
[units: Patients]
  41     249  


Statistical Analysis 1 for Incidence of Hypoglycaemic Events up to 52 Weeks
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin versus Glimepiride
[2] Other relevant method 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:
  This key secondary endpoint was only to be tested (comparing to a 2-sided threshold of 0.025) if the Week52 body weight change from baseline was confirmatory.



6.  Secondary:   Incidence of Hypoglycaemic Events up to 104 Weeks   [ Time Frame: Week 104 ]

Measure Type Secondary
Measure Title Incidence of Hypoglycaemic Events up to 104 Weeks
Measure Description A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a HBGM of below 55 mg/dl (3.1 mmol/L)
Time Frame Week 104  
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 treated set consisted of all patients treated with at least one dose of study drug

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  776     775  
Incidence of Hypoglycaemic Events up to 104 Weeks  
[units: Patients]
  58     280  


Statistical Analysis 1 for Incidence of Hypoglycaemic Events up to 104 Weeks
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin versus Glimepiride
[2] Other relevant method 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:
  Due to testing of multiple endpoints within a visit a sequential testing strategy (at 2-sided threshold of 0.025) was applied to the key secondary endpoints.



7.  Secondary:   Fasting Plasma Glucose (FPG) Change From Baseline at Week 52   [ Time Frame: Baseline and week 52 ]

Measure Type Secondary
Measure Title Fasting Plasma Glucose (FPG) Change From Baseline at Week 52
Measure Description This change from baseline reflects the Week 52 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and the number of previous anti-diabetic medications.
Time Frame Baseline and week 52  
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.
This population includes the FAS further restricted to patients with a baseline FPG and one on-treatment FPG measurement. Last observation carried forward (LOCF) was used as imputation rule.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  733     725  
Fasting Plasma Glucose (FPG) Change From Baseline at Week 52  
[units: mg/dL]
Mean ± Standard Error
  -8.40  ± 1.25     -15.24  ± 1.26  


Statistical Analysis 1 for Fasting Plasma Glucose (FPG) Change From Baseline at Week 52
Groups [1] All groups
Method [2] ANCOVA
P Value [3] <0.0001
Least Squares Mean Difference [4] 6.84
Standard Error of the mean ± 1.70
95% Confidence Interval ( 3.51 to 10.16 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin versus Glimepiride
[2] Other relevant method 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.



8.  Secondary:   Fasting Plasma Glucose (FPG) Change From Baseline at Week 104   [ Time Frame: Baseline and week 104 ]

Measure Type Secondary
Measure Title Fasting Plasma Glucose (FPG) Change From Baseline at Week 104
Measure Description This change from baseline reflects the Week 104 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and number of previous anti-diabetic medications.
Time Frame Baseline and week 104  
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.
This population includes the FAS further restricted to patients with a baseline FPG and one on-treatment FPG measurement. Last observation carried forward (LOCF) was used as imputation rule.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  733     725  
Fasting Plasma Glucose (FPG) Change From Baseline at Week 104  
[units: mg/dL]
Mean ± Standard Error
  -2.34  ± 1.46     -8.72  ± 1.47  


Statistical Analysis 1 for Fasting Plasma Glucose (FPG) Change From Baseline at Week 104
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0012
Least Squares Mean Difference [4] 6.38
Standard Error of the mean ± 1.97
95% Confidence Interval ( 2.51 to 10.25 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin versus Glimepiride
[2] Other relevant method 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.



9.  Secondary:   Percentage of Patients With HbA1c <7.0% at Week 52   [ Time Frame: Week 52 ]

Measure Type Secondary
Measure Title Percentage of Patients With HbA1c <7.0% at Week 52
Measure Description The percentage of patients with an HbA1c value below 7.0% at week 52, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.
Time Frame Week 52  
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.
Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=7.0%.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  592     599  
Percentage of Patients With HbA1c <7.0% at Week 52  
[units: Percentage of patients]
  29.6     38.9  


Statistical Analysis 1 for Percentage of Patients With HbA1c <7.0% at Week 52
Groups [1] All groups
Method [2] Regression, Logistic
P Value [3] 0.0004
Odds Ratio (OR) [4] 0.625
95% Confidence Interval ( 0.482 to 0.811 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin versus Glimepiride
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
[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.



10.  Secondary:   Percentage of Patients With HbA1c <7.0% at Week 104   [ Time Frame: Week 104 ]

Measure Type Secondary
Measure Title Percentage of Patients With HbA1c <7.0% at Week 104
Measure Description The percentage of patients with an HbA1c value below 7.0% at week 104, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.
Time Frame Week 104  
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.
Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=7.0%.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  591     593  
Percentage of Patients With HbA1c <7.0% at Week 104  
[units: Percentage of patients]
  21.0     28.3  


Statistical Analysis 1 for Percentage of Patients With HbA1c <7.0% at Week 104
Groups [1] All groups
Method [2] Regression, Logistic
P Value [3] 0.0030
Odds Ratio (OR) [4] 0.654
95% Confidence Interval ( 0.494 to 0.866 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin versus Glimepiride
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
[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.



11.  Secondary:   Percentage of Patients With HbA1c <6.5% at Week 52   [ Time Frame: Week 52 ]

Measure Type Secondary
Measure Title Percentage of Patients With HbA1c <6.5% at Week 52
Measure Description The percentage of patients with an HbA1c value below 6.5% at week 52, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.
Time Frame Week 52  
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.
Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=6.5%.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  738     740  
Percentage of Patients With HbA1c <6.5% at Week 52  
[units: Percentage of patients]
  16.9     22.7  


Statistical Analysis 1 for Percentage of Patients With HbA1c <6.5% at Week 52
Groups [1] All groups
Method [2] Regression, Logistic
P Value [3] 0.0025
Odds Ratio (OR) [4] 0.648
95% Confidence Interval ( 0.489 to 0.859 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin versus Glimepiride
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
[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.



12.  Secondary:   Percentage of Patients With HbA1c <6.5% at Week 104   [ Time Frame: Week 104 ]

Measure Type Secondary
Measure Title Percentage of Patients With HbA1c <6.5% at Week 104
Measure Description The percentage of patients with an HbA1c value below 6.5% at week 104, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.
Time Frame Week 104  
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.
Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=6.5%.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  736     734  
Percentage of Patients With HbA1c <6.5% at Week 104  
[units: Percentage of patients]
  10.9     14.7  


Statistical Analysis 1 for Percentage of Patients With HbA1c <6.5% at Week 104
Groups [1] All groups
Method [2] Regression, Logistic
P Value [3] 0.0240
Odds Ratio (OR) [4] 0.689
95% Confidence Interval ( 0.498 to 0.952 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin versus Glimepiride
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
[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.



13.  Secondary:   Percentage of Patients With HbA1c Lowering by 0.5% at Week 104   [ Time Frame: Week 104 ]

Measure Type Secondary
Measure Title Percentage of Patients With HbA1c Lowering by 0.5% at Week 104
Measure Description Occurrence of relative efficacy response, defined as a lowering of 0.5% HbA1c at week 104
Time Frame Week 104  
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.
FAS (NCF)

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  764     755  
Percentage of Patients With HbA1c Lowering by 0.5% at Week 104  
[units: Percentage of patients]
  26.2     33.5  


Statistical Analysis 1 for Percentage of Patients With HbA1c Lowering by 0.5% at Week 104
Groups [1] All groups
Method [2] Regression, Logistic
P Value [3] 0.0018
Odds Ratio (OR) [4] 0.700
95% Confidence Interval ( 0.560 to 0.875 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin versus Glimepiride
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
[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.



14.  Secondary:   2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104   [ Time Frame: Baseline and week 104 ]

Measure Type Secondary
Measure Title 2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104
Measure Description This change from baseline reflects the Week 104 2 hr PPG minus the Baseline 2hr PPG. Means are treatment adjusted for baseline HbA1c, baseline 2hr PPG and number of previous anti-diabetic medications.
Time Frame Baseline and week 104  
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 in the FAS with a valid meal tolerance test (MTT) at baseline and at least one valid on-treatment MTT (MTT104).

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  212     222  
2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104  
[units: mg/dL]
Mean ± Standard Error
  -28.47  ± 4.32     -18.72  ± 4.28  


Statistical Analysis 1 for 2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0918
Least Squares Mean Difference [4] -9.47
Standard Error of the mean ± 5.77
95% Confidence Interval ( -21.07 to 1.59 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Linagliptin versus Glimepiride
[2] Other relevant method 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.



15.  Secondary:   HbA1c Change at Week 4   [ Time Frame: Baseline and week 4 ]

Measure Type Secondary
Measure Title HbA1c Change at Week 4
Measure Description Difference of base percent value [Week x(%) - baseline (%)]
Time Frame Baseline and week 4  
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 and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  764     755  
HbA1c Change at Week 4  
[units: Percent]
Mean ± Standard Deviation
  -0.26  ± 0.41     -0.33  ± 0.46  

No statistical analysis provided for HbA1c Change at Week 4



16.  Secondary:   HbA1c Change at Week 8   [ Time Frame: Baseline and week 8 ]

Measure Type Secondary
Measure Title HbA1c Change at Week 8
Measure Description No text entered.
Time Frame Baseline and week 8  
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 and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  764     755  
HbA1c Change at Week 8  
[units: Percent]
Mean ± Standard Deviation
  -0.37  ± 0.59     -0.58  ± 0.62  

No statistical analysis provided for HbA1c Change at Week 8



17.  Secondary:   HbA1c Change at Week 12   [ Time Frame: Baseline and week 12 ]

Measure Type Secondary
Measure Title HbA1c Change at Week 12
Measure Description No text entered.
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 and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  764     755  
HbA1c Change at Week 12  
[units: Percent]
Mean ± Standard Deviation
  -0.43  ± 0.64     -0.75  ± 0.69  

No statistical analysis provided for HbA1c Change at Week 12



18.  Secondary:   HbA1c Change at Week 16   [ Time Frame: Baseline and week 16 ]

Measure Type Secondary
Measure Title HbA1c Change at Week 16
Measure Description No text entered.
Time Frame Baseline and week 16  
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 and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  764     755  
HbA1c Change at Week 16  
[units: Percent]
Mean ± Standard Deviation
  -0.45  ± 0.66     -0.78  ± 0.73  

No statistical analysis provided for HbA1c Change at Week 16



19.  Secondary:   HbA1c Change at Week 28   [ Time Frame: Baseline and week 28 ]

Measure Type Secondary
Measure Title HbA1c Change at Week 28
Measure Description No text entered.
Time Frame Baseline and week 28  
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 and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  764     755  
HbA1c Change at Week 28  
[units: Percent]
Mean ± Standard Deviation
  -0.43  ± 0.73     -0.74  ± 0.81  

No statistical analysis provided for HbA1c Change at Week 28



20.  Secondary:   HbA1c Change at Week 40   [ Time Frame: Baseline and week 40 ]

Measure Type Secondary
Measure Title HbA1c Change at Week 40
Measure Description No text entered.
Time Frame Baseline and week 40  
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 and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  764     755  
HbA1c Change at Week 40  
[units: Percent]
Mean ± Standard Deviation
  -0.42  ± 0.77     -0.69  ± 0.83  

No statistical analysis provided for HbA1c Change at Week 40



21.  Secondary:   HbA1c Change at Week 52   [ Time Frame: Baseline and week 52 ]

Measure Type Secondary
Measure Title HbA1c Change at Week 52
Measure Description No text entered.
Time Frame Baseline and week 52  
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 and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  764     755  
HbA1c Change at Week 52  
[units: Percent]
Mean ± Standard Deviation
  -0.41  ± 0.82     -0.63  ± 0.85  

No statistical analysis provided for HbA1c Change at Week 52



22.  Secondary:   HbA1c Change at Week 65   [ Time Frame: Baseline and week 65 ]

Measure Type Secondary
Measure Title HbA1c Change at Week 65
Measure Description No text entered.
Time Frame Baseline and week 65  
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 and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  764     755  
HbA1c Change at Week 65  
[units: Percent]
Mean ± Standard Deviation
  -0.32  ± 0.91     -0.53  ± 0.87  

No statistical analysis provided for HbA1c Change at Week 65



23.  Secondary:   HbA1c Change at Week 78   [ Time Frame: Baseline and week 78 ]

Measure Type Secondary
Measure Title HbA1c Change at Week 78
Measure Description No text entered.
Time Frame Baseline and week 78  
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 and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  764     755  
HbA1c Change at Week 78  
[units: Percent]
Mean ± Standard Deviation
  -0.22  ± 0.92     -0.43  ± 0.90  

No statistical analysis provided for HbA1c Change at Week 78



24.  Secondary:   HbA1c Change at Week 91   [ Time Frame: Baseline and week 91 ]

Measure Type Secondary
Measure Title HbA1c Change at Week 91
Measure Description No text entered.
Time Frame Baseline and week 91  
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 and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  764     755  
HbA1c Change at Week 91  
[units: Percent]
Mean ± Standard Deviation
  -0.21  ± 0.94     -0.43  ± 0.90  

No statistical analysis provided for HbA1c Change at Week 91



25.  Secondary:   HbA1c Change at Week 104   [ Time Frame: Baseline and week 104 ]

Measure Type Secondary
Measure Title HbA1c Change at Week 104
Measure Description The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as imputation rule.
Time Frame Baseline and week 104  
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 and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  764     755  
HbA1c Change at Week 104  
[units: Percent]
Mean ± Standard Deviation
  -0.21  ± 0.95     -0.41  ± 0.93  

No statistical analysis provided for HbA1c Change at Week 104



26.  Secondary:   Change in Baseline Lipid Parameter Cholesterol at Week 104   [ Time Frame: Baseline and week 104 ]

Measure Type Secondary
Measure Title Change in Baseline Lipid Parameter Cholesterol at Week 104
Measure Description No text entered.
Time Frame Baseline and week 104  
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.
This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  741     726  
Change in Baseline Lipid Parameter Cholesterol at Week 104  
[units: mg/dL]
Mean ± Standard Deviation
  0  ± 14     1  ± 14  

No statistical analysis provided for Change in Baseline Lipid Parameter Cholesterol at Week 104



27.  Secondary:   Change in Baseline Lipid Parameter HDL at Week 104   [ Time Frame: Baseline and week 104 ]

Measure Type Secondary
Measure Title Change in Baseline Lipid Parameter HDL at Week 104
Measure Description No text entered.
Time Frame Baseline and week 104  
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.
This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  740     725  
Change in Baseline Lipid Parameter HDL at Week 104  
[units: mg/dl]
Mean ± Standard Deviation
  1  ± 9     0  ± 9  

No statistical analysis provided for Change in Baseline Lipid Parameter HDL at Week 104



28.  Secondary:   Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104   [ Time Frame: Baseline and week 104 ]

Measure Type Secondary
Measure Title Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104
Measure Description No text entered.
Time Frame Baseline and week 104  
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.
This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  734     720  
Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104  
[units: mg/dL]
Mean ± Standard Deviation
  1  ± 23     3  ± 25  

No statistical analysis provided for Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104



29.  Secondary:   Change in Baseline Lipid Parameter Triglyceride at Week 104   [ Time Frame: Baseline and week 104 ]

Measure Type Secondary
Measure Title Change in Baseline Lipid Parameter Triglyceride at Week 104
Measure Description No text entered.
Time Frame Baseline and week 104  
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.
This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.

Reporting Groups
  Description
Linagliptin Patients randomized to receive Linagliptin 5mg and metformin
Glimepiride Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values
    Linagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  740     725  
Change in Baseline Lipid Parameter Triglyceride at Week 104  
[units: mg/dL]
Mean ± Standard Deviation
  -11  ± 153     -7  ± 148  

No statistical analysis provided for Change in Baseline Lipid Parameter Triglyceride at Week 104




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
With the exception of HbA1c<6.5% and HbA1c<7.0% at Week52, all other endpoints are presented in the Week52 repeated analysis within the final clinical trial report, where discrepancies between interim and final results are also explained.


  More Information