Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01383356
First received: June 27, 2011
Last updated: February 27, 2014
Last verified: February 2014
Results First Received: December 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Metformin Single Tablet
Drug: Linagliptin/Metformin Combo
Drug: Linagliptin Single Tablet

  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
18 subjects were enrolled in the original study (June 2011 to July 2011) and 40 in the add-on study (November 2011 to December 2011) which was an option provided by protocol to increase the subject number. As no significant STUDY and STUDY-by-TREATMENT effect was revealed in analysis of pooled data, final analysis was performed on pooled data.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This is a 2 period, 2 sequence, 2 treatment crossover. Subjects were randomized to one of the two sequences AB or BA. The duration of washout was at least 35 days between dosing.

Reporting Groups
  Description
Lina/Met 2.5mg/500mg Then Lina 2.5mg Plus Met 500mg Combination tablet Linagliptin (Lina) /Metformin (Met) 2.5mg/500mg followed by single tablets Linagliptin 2.5mg plus Metformin 500mg
Lina 2.5mg Plus Met 500mg Then Lina/Met 2.5mg/500mg Single tablets Linagliptin 2.5mg plus Metformin 500mg followed by combination tablet Linagliptin/Metformin 2.5mg/500mg

Participant Flow for 3 periods

Period 1:   Period 1
    Lina/Met 2.5mg/500mg Then Lina 2.5mg Plus Met 500mg     Lina 2.5mg Plus Met 500mg Then Lina/Met 2.5mg/500mg  
STARTED     29 [1]   29 [1]
COMPLETED     21 [2]   23 [2]
NOT COMPLETED     8     6  
Adverse Event                 5                 3  
Non-compliance                 3                 0  
Out of Range Mid-study-Test                 0                 1  
Personal                 0                 2  
[1] Entered and treated.
[2] Completed period 1.

Period 2:   Washout Period (at Least 35 Days)
    Lina/Met 2.5mg/500mg Then Lina 2.5mg Plus Met 500mg     Lina 2.5mg Plus Met 500mg Then Lina/Met 2.5mg/500mg  
STARTED     21     23  
COMPLETED     21     23  
NOT COMPLETED     0     0  

Period 3:   Period 2
    Lina/Met 2.5mg/500mg Then Lina 2.5mg Plus Met 500mg     Lina 2.5mg Plus Met 500mg Then Lina/Met 2.5mg/500mg  
STARTED     21 [1]   23 [1]
COMPLETED     21 [2]   23 [2]
NOT COMPLETED     0     0  
[1] Entered and treated.
[2] Completed period 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.
Dosed participants from combined studies

Reporting Groups
  Description
Entire Study Population Total number of subjects randomised and treated in the study.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  58  
Age  
[units: years]
Mean ± Standard Deviation
  35  ± 9  
Gender  
[units: Participants]
 
Female     32  
Male     26  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Plasma Concentration (Cmax)   [ Time Frame: Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period ]

2.  Primary:   Area Under the Curve 0 to Last Measurable Value (AUC0-t)   [ Time Frame: Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period ]

3.  Secondary:   Area Under the Curve 0 to Inf (AUC0-inf)   [ Time Frame: Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


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: NCT01383356     History of Changes
Other Study ID Numbers: 1288.19
Study First Received: June 27, 2011
Results First Received: December 18, 2012
Last Updated: February 27, 2014
Health Authority: Canada: Health Canada