Assessment of the Effect of Empagliflozin (BI 10773) as Single Dose on the QT Interval in Healthy Female and Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01195675
First received: September 3, 2010
Last updated: July 25, 2014
Last verified: July 2014
Results First Received: May 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Crossover Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Healthy
Interventions: Drug: BI 10773 (low)
Drug: Moxifloxacin
Drug: BI 10773 Placebo
Drug: BI 10773 (high)

  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
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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
Study Overall

Total number of patients randomised and treated in the study. This was a randomised, placebo controlled, 5-period crossover trial, participants were randomised to one of ten possible treatment sequences. The treatments administered were

  • 25mg empa administered orally on day 1 of the treatment period
  • 200mg empa administered orally on day 1 of the treatment period
  • 400mg moxifloxacin administered orally on day 1 of the treatment period
  • Placebo 1 administered orally on day 1 of the treatment period
  • Placebo 2 administered orally on day 1 of the treatment period

The trial was double-blind for the placebo and Empagliflozin (Empa) treatments, but open-label for the moxifloxacin treatment. A washout period of at least 1 week was respected between drug administrations.


Participant Flow:   Overall Study
    Study Overall  
STARTED     30  
Received Empa 25mg     28  
Received Empa 200mg     30  
Received Moxifloxacin     29  
Received Placebo 1     29  
Received Placebo 2     28  
COMPLETED     27  
NOT COMPLETED     3  
Adverse Event                 1  
Withdrawal by Subject                 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.
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Reporting Groups
  Description
Study Overall Total number of patients randomised and treated in the study.

Baseline Measures
    Study Overall  
Number of Participants  
[units: participants]
  30  
Age  
[units: years]
Mean ± Standard Deviation
  34.5  ± 10.6  
Gender  
[units: participants]
 
Female     14  
Male     16  



  Outcome Measures
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1.  Primary:   Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing   [ Time Frame: 60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose ]

2.  Primary:   Empa 200mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing   [ Time Frame: 60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose ]

3.  Secondary:   Empa 25 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing   [ Time Frame: 60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose ]

4.  Secondary:   Empa 200 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing   [ Time Frame: 60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose ]

5.  Secondary:   Mean QTcN Change From Baseline Between 2 and 4 Hours After Dosing   [ Time Frame: 60 minutes (min), 50min and 40 min before the first dose and 2 hour (h), 2.5h, 3h and 4h after the first dose ]

6.  Secondary:   Empa 25mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings   [ Time Frame: 60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose ]

7.  Secondary:   Empa 200mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings   [ Time Frame: 60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose ]

8.  Other Pre-specified:   Time-matched Change From Placebo in QTcN Between 30 Minutes and 24 Hours After Dosing.   [ Time Frame: 60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose ]

9.  Other Pre-specified:   Placebo Corrected Change From Mean Baseline at Any Time Point Between 30 Minutes and 24 Hours After Dosings.   [ Time Frame: 60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose ]

10.  Other Pre-specified:   Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator   [ Time Frame: Drug administration until beginning of next sequence/end of trial, up to 48 days ]


  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: NCT01195675     History of Changes
Other Study ID Numbers: 1245.16, 2010-018609-13
Study First Received: September 3, 2010
Results First Received: May 16, 2014
Last Updated: July 25, 2014
Health Authority: Germany: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)
United States: Food and Drug Administration