Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01826370
First received: April 4, 2013
Last updated: September 17, 2014
Last verified: September 2014
Results First Received: September 10, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Diabetes Mellitus, Type 2
Intervention: Drug: Linagliptin

  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
Linagliptin Linagliptin 5 mg was administered orally once a day for 24 weeks

Participant Flow:   Overall Study
    Linagliptin  
STARTED     678  
COMPLETED     658  
NOT COMPLETED     20  
Protocol Violation                 6  
Lost to Follow-up                 12  
Other reason not defined above                 2  



  Baseline Characteristics
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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.
Safety analysis set which consisted of all patients who have taken at least one dose of linagliptin and participated in the follow-up visit, thus, having a baseline and end-point evaluation.

Reporting Groups
  Description
Linagliptin Linagliptin 5 mg was administered orally once a day for 24 weeks

Baseline Measures
    Linagliptin  
Number of Participants  
[units: participants]
  660  
Age [1]
[units: years]
Mean ± Standard Deviation
  57.67  ± 13.3  
Gender [2]
[units: participants]
 
Female     360  
Male     296  
[1] Age information is missing for 5 patients
[2] Gender information is missing for 4 patients



  Outcome Measures
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1.  Primary:   Frequency of Adverse Events and Serious Adverse Events   [ Time Frame: Week 24 ]

2.  Secondary:   Change From Baseline to Week 24 of HbA1c   [ Time Frame: Baseline and 24 weeks ]

3.  Secondary:   Change From Baseline to Week 24 of Fasting Blood Sugar   [ Time Frame: Baseline and 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


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
ClinicalTrials.gov Identifier: NCT01826370     History of Changes
Other Study ID Numbers: 1218.94
Study First Received: April 4, 2013
Results First Received: September 10, 2014
Last Updated: September 17, 2014
Health Authority: Philippines: Bureau of Food and Drugs