Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01581658
First received: April 17, 2012
Last updated: May 16, 2014
Last verified: May 2014
Results First Received: May 16, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Intervention: Drug: BI10773

  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
Normal Renal Function 25 mg empagliflozin taken as a single dose for patients with normal renal function
Mild Renal Impairment 25 mg empagliflozin taken as a single dose for patients with mild renal impairment
Moderate Renal Impairment 25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
Severe Renal Impairment 25 mg empagliflozin taken as a single dose for patients with severe renal impairment

Participant Flow:   Overall Study
    Normal Renal Function     Mild Renal Impairment     Moderate Renal Impairment     Severe Renal Impairment  
STARTED     8     8     8     8  
COMPLETED     8     8     8     8  
NOT COMPLETED     0     0     0     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
Normal Renal Function 25 mg empagliflozin taken as a single dose for patients with normal renal function
Mild Renal Impairment 25 mg empagliflozin taken as a single dose for patients with mild renal impairment
Moderate Renal Impairment 25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
Severe Renal Impairment 25 mg empagliflozin taken as a single dose for patients with severe renal impairment
Total Total of all reporting groups

Baseline Measures
    Normal Renal Function     Mild Renal Impairment     Moderate Renal Impairment     Severe Renal Impairment     Total  
Number of Participants  
[units: participants]
  8     8     8     8     32  
Age  
[units: years]
Mean ± Standard Deviation
  66.8  ± 3.1     67.5  ± 4.4     65.9  ± 5.5     62.0  ± 7.9     65.5  ± 5.6  
Gender  
[units: participants]
         
Female     4     3     0     2     9  
Male     4     5     8     6     23  



  Outcome Measures
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1.  Primary:   Change From Baseline in Total Urinary Glucose Excretion (UGE)   [ Time Frame: baseline and 24 hours ]

2.  Primary:   Area Under the Concentration Time Curve of the Analyte in Plasma   [ Time Frame: Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration ]

3.  Primary:   Maximum Concentration   [ Time Frame: Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration ]


  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: NCT01581658     History of Changes
Other Study ID Numbers: 1245.53
Study First Received: April 17, 2012
Results First Received: May 16, 2014
Last Updated: May 16, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare