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Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects 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:
NCT01368081
First received: May 19, 2011
Last updated: May 16, 2014
Last verified: May 2014
History of Changes
Results First Received: May 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Metformin
Drug: BI 10773
Drug: Placebo (low dose)
Drug: Placebo (high 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
Sulfonylurea: Empa 10mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
Sulfonylurea: Empa 25mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
Sulfonylurea: Metformin 250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
Biguanide: Empa 10mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
Biguanide: Empa 25mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
Thiazolidinedione: Empa 10mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
Thiazolidinedione: Empa 25mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
Alpha Glucosidase Inhibitor: Empa 10mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
Alpha Glucosidase Inhibitor: Empa 25mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
DPP−IV Inhibitor: Empa 10mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP−IV) inhibitor
DPP−IV Inhibitor: Empa 25mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP−IV) inhibitor
Glinide: Empa 10mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
Glinide: Empa 25mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide

Participant Flow:   Overall Study
    Sulfonylurea: Empa 10mg     Sulfonylurea: Empa 25mg     Sulfonylurea: Metformin     Biguanide: Empa 10mg     Biguanide: Empa 25mg     Thiazolidinedione: Empa 10mg     Thiazolidinedione: Empa 25mg     Alpha Glucosidase Inhibitor: Empa 10mg     Alpha Glucosidase Inhibitor: Empa 25mg     DPP−IV Inhibitor: Empa 10mg     DPP−IV Inhibitor: Empa 25mg     Glinide: Empa 10mg     Glinide: Empa 25mg  
STARTED     136     137     63     68     65     137     136     69     70     68     71     70     70  
COMPLETED     126     128     59     63     63     127     124     62     62     58     62     67     63  
NOT COMPLETED     10     9     4     5     2     10     12     7     8     10     9     3     7  
Adverse Event                 4                 4                 3                 2                 2                 5                 6                 2                 3                 5                 6                 1                 3  
Lack of Efficacy                 0                 1                 0                 1                 0                 0                 0                 2                 0                 0                 0                 0                 0  
Protocol Violation                 0                 0                 0                 0                 0                 1                 0                 1                 0                 0                 0                 0                 0  
Lost to Follow-up                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 1  
Withdrawal by Subject                 4                 4                 1                 1                 0                 3                 4                 2                 5                 4                 3                 2                 0  
Other reason not defined above                 2                 0                 0                 1                 0                 1                 2                 0                 0                 1                 0                 0                 3  



  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
Sulfonylurea: Empa 10mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
Sulfonylurea: Empa 25mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
Sulfonylurea: Metformin 250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
Biguanide: Empa 10mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
Biguanide: Empa 25mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
Thiazolidinedione: Empa 10mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
Thiazolidinedione: Empa 25mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
Alpha Glucosidase Inhibitor: Empa 10mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
Alpha Glucosidase Inhibitor: Empa 25mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
DPP−IV Inhibitor: Empa 10mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
DPP−IV Inhibitor: Empa 25mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
Glinide: Empa 10mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
Glinide: Empa 25mg One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
Total Total of all reporting groups

Baseline Measures
    Sulfonylurea: Empa 10mg     Sulfonylurea: Empa 25mg     Sulfonylurea: Metformin     Biguanide: Empa 10mg     Biguanide: Empa 25mg     Thiazolidinedione: Empa 10mg     Thiazolidinedione: Empa 25mg     Alpha Glucosidase Inhibitor: Empa 10mg     Alpha Glucosidase Inhibitor: Empa 25mg     DPP−IV Inhibitor: Empa 10mg     DPP−IV Inhibitor: Empa 25mg     Glinide: Empa 10mg     Glinide: Empa 25mg     Total  
Number of Participants  
[units: participants]
 		  136     137     63     68     65     137     136     69     70     68     71     70     70     1160  
Age  
[units: years]
Mean (Standard Deviation) 		  61.3  (9.9)     61.8  (9.6)     60.0  (10.2)     56.9  (9.5)     57.3  (11.4)     60.4  (10.1)     59.7  (9.9)     63.5  (8.8)     61.9  (11.7)     63.3  (9.9)     59.1  (10.3)     59.2  (12.1)     57.7  (11.8)     60.3  (10.4)  
Gender  
[units: participants]
 		                           
Female     37     41     16     30     22     23     34     18     18     27     23     23     13     325  
Male     99     96     47     38     43     114     102     51     52     41     48     47     57     835  



  Outcome Measures
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1.  Primary:   Number of Patients With Drug Related Adverse Events   [ Time Frame: After the first drug intake until 7 days after the last treatment administration, up to 383 days ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in HbA1c   [ Time Frame: Baseline and 52 weeks ]
  Show Outcome Measure 2

3.  Other Pre-specified:   Confirmed Hypoglycaemic Adverse Events   [ Time Frame: After the first drug intake until 7 days after the last treatment administration, up to 383 days ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01368081     History of Changes
Other Study ID Numbers: 1245.52
Study First Received: May 19, 2011
Results First Received: May 16, 2014
Last Updated: May 16, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare