Safety and Efficacy of Empagliflozin (BI 10773) in Type 1 Diabetes Mellitus Patients With or Without Renal Hyperfiltration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01392560
First received: July 11, 2011
Last updated: May 16, 2014
Last verified: May 2014
Results First Received: May 16, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 1
Intervention: Drug: BI 10773

  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
Empagliflozin (BI 10773) 25 mg

Oral once daily

Empagliflozin 25 mg: Oral once daily


Participant Flow:   Overall Study
    Empagliflozin (BI 10773) 25 mg  
STARTED     52  
COMPLETED     40  
NOT COMPLETED     12  
Adverse Event                 2  
not entered                 8  
discontinued during placebo run-in                 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.
Treated Set

Reporting Groups
  Description
Empagliflozin (BI 10773) 25 mg

Oral once daily

Empagliflozin 25 mg: Oral once daily


Baseline Measures
    Empagliflozin (BI 10773) 25 mg  
Number of Participants  
[units: participants]
  42  
Age  
[units: years]
Mean ± Standard Deviation
  24.1  ± 5.0  
Gender  
[units: participants]
 
Female     22  
Male     20  



  Outcome Measures

1.  Primary:   Change in Glomerular Filtration Rate (GFR) After 8 Weeks of Treatment With Empagliflozin Under Controlled Conditions of Euglycaemia and Hyperglycaemia   [ Time Frame: Baseline and 8 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 by Boehringer Ingelheim

Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01392560     History of Changes
Other Study ID Numbers: 1245.46
Study First Received: July 11, 2011
Results First Received: May 16, 2014
Last Updated: May 16, 2014
Health Authority: Canada: Health Canada