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A Study to Determine Acute (After First Dose) and Chronic (After 28 Days) Effects of Empagliflozin (BI 10773) on Pre and Postprandial Glucose Homeostasis in Patients With Impaired Glucose Tolerance and Type 2 Diabetes Mellitus and Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01248364
First received: November 24, 2010
Last updated: August 29, 2014
Last verified: August 2014
Results First Received: August 29, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
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
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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
T2DM Naive Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
T2DM Metformin Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Impaired Glucose Tolerance Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Healthy Subjects Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.

Participant Flow:   Overall Study
    T2DM Naive     T2DM Metformin     Impaired Glucose Tolerance     Healthy Subjects  
STARTED     32     34     13     12  
Completed Acute Phase:Single Dose, Day 1     32     34     13     12  
Completed Chronic Phase:28-day Treatment     32     33     13     0  
COMPLETED     32     33     13     12  
NOT COMPLETED     0     1     0     0  
Adverse Event                 0                 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.
Treated set which included all patients/healthy subjects treated with at least one dose of empagliflozin.

Reporting Groups
  Description
T2DM Naive Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
T2DM Metformin Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Impaired Glucose Tolerance Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Healthy Subjects Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Total Total of all reporting groups

Baseline Measures
    T2DM Naive     T2DM Metformin     Impaired Glucose Tolerance     Healthy Subjects     Total  
Number of Participants  
[units: participants]
  32     34     13     12     91  
Age  
[units: years]
Mean ± Standard Deviation
  60.1  ± 7.0     63.3  ± 6.5     50.8  ± 9.8     47.7  ± 2.3     58.3  ± 8.9  
Gender  
[units: participants]
         
Female     11     10     5     2     28  
Male     21     24     8     10     63  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Fasting Plasma Glucose at Day 1   [ Time Frame: Baseline and day 1 ]

2.  Primary:   Change From Baseline in Fasting Plasma Glucose at Day 28   [ Time Frame: Baseline and day 28 ]

3.  Primary:   Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 1   [ Time Frame: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1 ]

4.  Primary:   Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 28   [ Time Frame: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28 ]

5.  Secondary:   Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 1   [ Time Frame: Baseline and day 1 ]

6.  Secondary:   Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 28   [ Time Frame: Baseline and day 28 ]

7.  Secondary:   Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 1   [ Time Frame: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1 ]

8.  Secondary:   Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 28   [ Time Frame: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28 ]

9.  Secondary:   Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 1   [ Time Frame: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and day 1 ]

10.  Secondary:   Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 28   [ Time Frame: 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and 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 by Boehringer Ingelheim

Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01248364     History of Changes
Other Study ID Numbers: 1245.39, 2010-018708-99
Study First Received: November 24, 2010
Results First Received: August 29, 2014
Last Updated: August 29, 2014
Health Authority: Austria: Medicines and Medical Devices Agency
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee