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4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00885118
First received: April 20, 2009
Last updated: November 13, 2014
Last verified: November 2014
Results First Received: May 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 (middle dose)
Drug: Placebo
Drug: BI 10773
Drug: Placebo (high dose)
Drug: Placebo (low dose)

  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 Treatment with placebo once daily
Empa 1 mg Treatment with Empa 1 mg once daily
Empa 5 mg Treatment with Empa 5 mg once daily
Empa 10 mg Treatment with Empa 10 mg once daily
Empa 25 mg Treatment with Empa 25 mg once daily

Participant Flow:   Overall Study
    Placebo     Empa 1 mg     Empa 5 mg     Empa 10 mg     Empa 25 mg  
STARTED     21     19     21     20     19  
COMPLETED     20     19     20     20     18  
NOT COMPLETED     1     0     1     0     1  
Adverse Event                 1                 0                 0                 0                 0  
Withdrawal by Subject                 0                 0                 0                 0                 1  
Other reason not defined above                 0                 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.
No text entered.

Reporting Groups
  Description
Placebo Treatment with placebo once daily
Empa 1 mg Treatment with Empa 1 mg once daily
Empa 5 mg Treatment with Empa 5 mg once daily
Empa 10 mg Treatment with Empa 10 mg once daily
Empa 25 mg Treatment with Empa 25 mg once daily
Total Total of all reporting groups

Baseline Measures
    Placebo     Empa 1 mg     Empa 5 mg     Empa 10 mg     Empa 25 mg     Total  
Number of Participants  
[units: participants]
  21     19     21     20     19     100  
Age  
[units: years]
Mean ± Standard Deviation
  57.2  ± 10.0     58.6  ± 8.2     53.9  ± 9.9     55.8  ± 8.0     60.8  ± 8.7     57.2  ± 9.2  
Gender  
[units: participants]
           
Female     5     3     1     3     4     16  
Male     16     16     20     17     15     84  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Urine Glucose Excretion   [ Time Frame: baseline and 28 days ]

2.  Primary:   Change From Baseline in Fasting Plasma Glucose   [ Time Frame: baseline and 28 days ]

3.  Primary:   Change From Baseline in 8-point Glucose   [ Time Frame: baseline and 27 days ]

4.  Secondary:   Change From Baseline in HbA1c   [ Time Frame: baseline and 28 days ]

5.  Secondary:   Change From Baseline in Fructosamine   [ Time Frame: baseline and 28 days ]

6.  Secondary:   Change From Baseline in 1,5-anhydroglucitol   [ Time Frame: baseline and 28 days ]

7.  Secondary:   Change From Baseline in Fasting Insulin   [ Time Frame: baseline and 28 days ]

8.  Secondary:   Change From Baseline in the Area Under the Curve of Plasma Glucose Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)   [ Time Frame: baseline and 28 days ]

9.  Secondary:   Change From Baseline in the Area Under the Curve of Glucagon Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)   [ Time Frame: baseline and 28 days ]

10.  Secondary:   Change From Baseline in the Area Under the Curve of Insulin Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)   [ Time Frame: baseline and 28 days ]

11.  Secondary:   AUCτ,1   [ Time Frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration ]

12.  Secondary:   AUC0-tz   [ Time Frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration ]

13.  Secondary:   AUC0-∞   [ Time Frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration ]

14.  Secondary:   Cmax   [ Time Frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration ]

15.  Secondary:   t1/2   [ Time Frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration ]

16.  Secondary:   CL/F   [ Time Frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration ]

17.  Secondary:   Vz/F   [ Time Frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration ]

18.  Secondary:   Ae0-24   [ Time Frame: 0-5, 5-12, 12-24 hour after first drug administration ]

19.  Secondary:   fe0-24   [ Time Frame: 0-5, 5-12, 12-24 hour after first drug administration ]

20.  Secondary:   CLR,0-24   [ Time Frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min, 0-5h, 5-12h, 12-24h after first drug administration ]

21.  Secondary:   AUCτ,ss   [ Time Frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration ]

22.  Secondary:   Cmax,ss   [ Time Frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration ]

23.  Secondary:   t1/2,ss   [ Time Frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration ]

24.  Secondary:   CL/F,ss   [ Time Frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration ]

25.  Secondary:   Vz/F,ss   [ Time Frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration ]

26.  Secondary:   RA,Cmax   [ Time Frame: Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration ]

27.  Secondary:   RA,AUC   [ Time Frame: Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration ]

28.  Secondary:   Ae0-24,ss   [ Time Frame: 0-5, 5-12, 12-24 hour after last drug administration ]

29.  Secondary:   fe0-24,ss   [ Time Frame: 0-5, 5-12, 12-24 hour after last drug administration ]

30.  Secondary:   CLR,ss   [ Time Frame: Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 0-5h, 5-12h, 12-24h after last drug administration ]


  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
Additional secondary endpoints were listed in the original protocol. Those endpoints are of exploratory nature only and were not considered relevant for trial conclusions. For more information see tab “Full Text Review”, section “More Information”.


  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: NCT00885118     History of Changes
Other Study ID Numbers: 1245.15
Study First Received: April 20, 2009
Results First Received: May 16, 2014
Last Updated: November 13, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare