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A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00740051
First received: August 21, 2008
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
Results First Received: August 3, 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
Drug: Linagliptin Placebo
Drug: Glimepiride

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo/Glimepiride Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
Linagliptin Patients treated with Linagliptin 5mg once daily (up to 52 weeks)

Participant Flow:   Overall Study
    Placebo/Glimepiride     Linagliptin  
STARTED     76     151  
COMPLETED     58     119  
NOT COMPLETED     18     32  
Lack of Efficacy                 2                 5  
Adverse Event                 1                 4  
Protocol Violation                 2                 6  
Lost to Follow-up                 3                 8  
Withdrawal by Subject                 6                 8  
Other reason (not specified)                 4                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo/Glimepiride Patients treated with matching placebo (up to 18 weeks) followed by Glimepiride (after 18 weeks to 52 weeks)
Linagliptin Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
Total Total of all reporting groups

Baseline Measures
    Placebo/Glimepiride     Linagliptin     Total  
Number of Participants  
[units: participants]
 		  76     151     227  
Age  
[units: Years]
Mean ± Standard Deviation 		  56.7  ± 9.7     56.4  ± 10.6     56.5  ± 10.3  
Gender  
[units: Patients]
 		     
Female     43     96     139  
Male     33     55     88  
Body Mass Index (BMI) continuous  
[units: kg/m^2]
Mean ± Standard Deviation 		  30.19  ± 4.97     29.09  ± 5.62     29.46  ± 5.42  
Glycosylated hemoglobin (HbA1c) [1]
[units: percent]
Mean ± Standard Deviation 		  8.06  ± 0.89     8.11  ± 0.95     8.09  ± 0.93  
Fasting blood plasma (FPG) glucose [2]
[units: mg/dL]
Mean ± Standard Deviation 		  180.5  ± 44.7     183.3  ± 46.4     182.4  ± 45.8  
[1] Baseline HbA1c was determined for the Full Analysis Set with a total of 73 patients treated with Placebo and 147 patients treated with Linagliptin (220 in total).
[2] Baseline fasting blood plasma glucose was determined for the Full Analysis Set with a total of 73 patients treated with Placebo and 147 patients treated with Linagliptin (220 in total).



  Outcome Measures
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1.  Primary:   HbA1c Change From Baseline at Week 18 (Interim Analysis)   [ Time Frame: Baseline and week 18 ]
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2.  Primary:   HbA1c Change From Baseline at Week 18 (Final Analysis)   [ Time Frame: Baseline and week 18 ]
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3.  Secondary:   Fasting Plasma Glucose (FPG) Change From Baseline at Week 18   [ Time Frame: Baseline and week 18 ]
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4.  Secondary:   Percentage of Patients With HbA1c<7.0 at Week 18   [ Time Frame: Week 18 ]
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5.  Secondary:   Percentage of Patients With HbA1c<6.5 at Week 18   [ Time Frame: Week 18 ]
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6.  Secondary:   Percentage of Patients With HbA1c Lowering by 0.5% at Week 18   [ Time Frame: Week 18 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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