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Study Results
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This study has been completed.
Study NCT00309608   Information provided by Boehringer Ingelheim Pharmaceuticals

First Received on March 31, 2006.   Last Updated on July 6, 2011   History of Changes
Results First Received: May 13, 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: 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
No text entered.

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 Patients randomized to receive treatment with matching placebo
Linagliptin 1 mg Patients randomized to receive treatment with Linagliptin 1 mg
Linagliptin 5 mg Patients randomized to receive treatment with Linagliptin 5 mg
Linagliptin 10 mg Patients randomized to receive treatment with Linagliptin 10 mg
Glimepiride Patients randomized to receive treatment with Glimepiride

Participant Flow:   Overall Study
    Placebo     Linagliptin 1 mg     Linagliptin 5 mg     Linagliptin 10 mg     Glimepiride  
STARTED     71     65     66     66     65  
COMPLETED     57     52     56     60     61  
NOT COMPLETED     14     13     10     6     4  
Adverse Event                 1                 5                 3                 2                 3  
Protocol Violation                 2                 0                 0                 0                 0  
Lost to Follow-up                 0                 0                 2                 0                 1  
Withdrawal by Subject                 1                 4                 2                 0                 0  
Other incl. Lack of efficacy                 10                 4                 3                 4                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Patients randomized to receive treatment with matching placebo
Linagliptin 1 mg Patients randomized to receive treatment with Linagliptin 1 mg
Linagliptin 5 mg Patients randomized to receive treatment with Linagliptin 5 mg
Linagliptin 10 mg Patients randomized to receive treatment with Linagliptin 10 mg
Glimepiride Patients randomized to receive treatment with Glimepiride

Baseline Measures
    Placebo     Linagliptin 1 mg     Linagliptin 5 mg     Linagliptin 10 mg     Glimepiride     Total  
Number of Participants  
[units: participants]
  71     65     66     66     65     333  
Age  
[units: Years]
Mean ± Standard Deviation
  60.1  ± 8.1     59.2  ± 8.4     59.6  ± 9.8     61.8  ± 8.8     59.4  ± 9.9     60.0  ± 9.0  
Gender  
[units: participants]
           
Female     27     29     29     31     24     140  
Male     44     36     37     35     41     193  
Body Mass Index (BMI) continuous  
[units: kg/m^2]
Mean ± Standard Deviation
  32.2  ± 4.2     32.3  ± 4.3     31.7  ± 4.5     31.7  ± 4.5     31.5  ± 4.2     31.9  ± 4.3  
Glycosylated Hemoglobin A1 (HbA1C) continuous  
[units: Percent]
Mean ± Standard Deviation
  8.37  ± 0.74     8.24  ± 0.74     8.46  ± 0.85     8.35  ± 0.73     8.22  ± 0.70     8.33  ± 0.75  
Fasting plasma glucose (FPG) continuous  
[units: mg/dL]
Mean ± Standard Deviation
  185.5  ± 38.8     182.3  ± 42.0     189.3  ± 42.4     188.7  ± 42.4     179.9  ± 40.4     185.1  ± 41.0  



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

2.  Secondary:   Percentage of Patients With HbA1c<=7.0% at Week 12   [ Time Frame: week 12 ]

3.  Secondary:   Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12   [ Time Frame: Baseline and week 12 ]


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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
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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


Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00309608     History of Changes
Other Study ID Numbers: 1218.6, 2005-004597-24
Study First Received: March 31, 2006
Results First Received: May 13, 2011
Last Updated: July 6, 2011
Health Authority: France: AFSSAPS;   Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte;   Great Britain: MHRA;   Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26;   Sweden: Medical Products Agency;   Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)