Post Prandial Glucose (PPG) Study of Empagliflozin in Japanese Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01947855
First received: September 18, 2013
Last updated: December 16, 2014
Last verified: December 2014
Results First Received: December 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Placebo
Drug: Empagliflozin

  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
Placebo Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
Empagliflozin 10 mg Empagliflozin 10 mg oral administration once daily
Empagliflozin 25 mg Empagliflozin 25mg oral administration once daily

Participant Flow:   Overall Study
    Placebo     Empagliflozin 10 mg     Empagliflozin 25 mg  
STARTED     21     20     19  
COMPLETED     20     20     19  
NOT COMPLETED     1     0     0  
Withdrawal by Subject                 1                 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.
Full analysis set: all patients treated with at least 1 dose of randomised study drug, and with a baseline AUC1-4h for plasma glucose.

Reporting Groups
  Description
Placebo Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
Empagliflozin 10 mg Empagliflozin 10 mg oral administration once daily
Empagliflozin 25 mg Empagliflozin 25mg oral administration once daily
Total Total of all reporting groups

Baseline Measures
    Placebo     Empagliflozin 10 mg     Empagliflozin 25 mg     Total  
Number of Participants  
[units: participants]
  21     20     19     60  
Age  
[units: years]
Mean ± Standard Deviation
  60.7  ± 10.8     64.8  ± 5.9     62.6  ± 7.8     62.7  ± 8.5  
Gender  
[units: participants]
       
Female     4     6     3     13  
Male     17     14     16     47  



  Outcome Measures

1.  Primary:   Change in Area Under the Concentration-time Curve (AUC1-4h) for Postprandial Plasma Glucose From Baseline After 28 Days of Treatment   [ Time Frame: 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day -1 (baseline), and 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day 28 ]


  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: NCT01947855     History of Changes
Other Study ID Numbers: 1245.35
Study First Received: September 18, 2013
Results First Received: December 16, 2014
Last Updated: December 16, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare