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Effect of Empagliflozin Kinetics on Renal Glucose Reabsorption in Patients With Type II Diabetes and Healthy Controls

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01867307
First received: May 21, 2013
Last updated: March 31, 2017
Last verified: March 2017
Results First Received: March 31, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Diabetes Mellitus, Type 2
Healthy
Interventions: Drug: Empagliflozin
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
39 subjects were enrolled in the trial; 37 subjects were treated with the trial treatment, 2 subjects were not treated with the trial treatment (1 subject from type 2 diabetes mellitus (T2DM) patients arm and 1 subject from the Healthy subjects arm were not treated)

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
T2DM Patients Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days
Healthy Subjects Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days

Participant Flow:   Overall Study
    T2DM Patients   Healthy Subjects
STARTED   18 [1]   19 [1] 
COMPLETED   15   16 
NOT COMPLETED   3   3 
Protocol Violation                2                0 
Other Adverse Event                1                3 
[1] Started are the treated patients



  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.
The treated set (TS) consisted of all subjects and patients who were treated with at least one dose of empagliflozin.

Reporting Groups
  Description
T2DM Patients Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days
Healthy Subjects Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
Total Total of all reporting groups

Baseline Measures
   T2DM Patients   Healthy Subjects   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   19   37 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.1  (5.5)   56.7  (6.3)   55.9  (5.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  27.8%      7  36.8%      12  32.4% 
Male      13  72.2%      12  63.2%      25  67.6% 


  Outcome Measures

1.  Primary:   Change From Baseline of Renal Tubular Maximum Reabsorptive Capacity for Glucose (TmG) at End of Empagliflozin Treatment (Day 14)   [ Time Frame: Baseline and Day 14 ]


  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
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01867307     History of Changes
Other Study ID Numbers: 1245.66
Study First Received: May 21, 2013
Results First Received: March 31, 2017
Last Updated: March 31, 2017