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Pharmacokinetics of Fixed Dose Combination (FDC) Tablets of Linagliptin /Metformin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01540487
First received: February 23, 2012
Last updated: June 6, 2013
Last verified: June 2013
Results First Received: June 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Healthy
Interventions: Drug: linagliptin/metformin(high dose)
Drug: Linagliptin/metformin(low dose)

  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
No text entered.

Reporting Groups
  Description
Lina 2.5mg, Metformin 850mg All patients receiving Linagliptin 2.5mg and Metformin 850mg.
Lina 2.5mg, Metformin 500mg All patients receiving Linagliptin 2.5mg and Metformin 500mg.

Participant Flow:   Overall Study
    Lina 2.5mg, Metformin 850mg   Lina 2.5mg, Metformin 500mg
STARTED   24   24 
COMPLETED   23   24 
NOT COMPLETED   1   0 
Protocol Violation                1                0 



  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.
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Reporting Groups
  Description
Lina 2.5mg, Metformin 850mg All patients receiving Linagliptin 2.5mg and Metformin 850mg.
Lina 2.5mg, Metformin 500mg All patients receiving Linagliptin 2.5mg and Metformin 500mg.
Total Total of all reporting groups

Baseline Measures
   Lina 2.5mg, Metformin 850mg   Lina 2.5mg, Metformin 500mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   24   48 
Age 
[Units: Years]
Mean (Standard Deviation)
 27.8  (4.4)   28.6  (4.8)   28.2  (4.6) 
Gender 
[Units: Participants]
     
Female   12   12   24 
Male   12   12   24 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72)   [ Time Frame: 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter. ]

2.  Primary:   Maximum Measured Concentration (Cmax) of Linagliptin.   [ Time Frame: 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter. ]

3.  Primary:   Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval 0 to the Last Quantifiable Concentration (AUC0-tz)   [ Time Frame: 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter. ]

4.  Primary:   Maximum Measured Concentration (Cmax) of Metformin   [ Time Frame: 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter. ]

5.  Secondary:   Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) for Linagliptin   [ Time Frame: 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter. ]

6.  Secondary:   AUC(0-infinity) for Metformin   [ Time Frame: 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter. ]

7.  Secondary:   AUC0-tz for Linagliptin   [ Time Frame: 1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter. ]


  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



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01540487     History of Changes
Other Study ID Numbers: 1288.5
Study First Received: February 23, 2012
Results First Received: June 6, 2013
Last Updated: June 6, 2013