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Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01368081
Recruitment Status : Completed
First Posted : June 7, 2011
Results First Posted : June 17, 2014
Last Update Posted : June 17, 2014
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Metformin
Drug: BI 10773
Drug: Placebo (low dose)
Drug: Placebo (high dose)

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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
First Submitted: May 19, 2011
First Posted: June 7, 2011
Results First Submitted: May 16, 2014
Results First Posted: June 17, 2014
Last Update Posted: June 17, 2014