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BI 10773 add-on to Metformin in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00749190
Recruitment Status : Completed
First Posted : September 9, 2008
Results First Posted : June 13, 2014
Last Update Posted : June 13, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: BI 10773
Drug: placebo
Drug: sitagliptin

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Placebo Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
Empagliflozin 1 mg Patients receive 1 mg Empagliflozin in tablets once daily.
Empagliflozin 5 mg Patients receive 5 mg Empagliflozin in tablets once daily.
Empagliflozin 10 mg Patients receive 10 mg Empagliflozin in tablets once daily.
Empagliflozin 25 mg Patients receive 25 mg Empagliflozin in tablets once daily.
Empagliflozin 50 mg Patients receive 50 mg Empagliflozin in tablets once daily.
Sitagliptin OL Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.

Participant Flow:   Overall Study
    Placebo   Empagliflozin 1 mg   Empagliflozin 5 mg   Empagliflozin 10 mg   Empagliflozin 25 mg   Empagliflozin 50 mg   Sitagliptin OL
STARTED   71   71   71   71   70   70   71 
COMPLETED   66   66   70   66   70   65   70 
NOT COMPLETED   5   5   1   5   0   5   1 
Adverse Event                0                2                0                4                0                3                0 
Lack of Efficacy                3                1                1                0                0                1                0 
Withdrawal by Subject                2                1                0                0                0                1                0 
Protocol Violation                0                1                0                0                0                0                1 
Other reason not defined above                0                0                0                1                0                0                0 



  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.
Treated Set (TS) consisting of all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.

Reporting Groups
  Description
Placebo Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily.
Empa 1 mg Patients receive 1 mg Empagliflozin in tablets once daily.
Empa 5 mg Patients receive 5 mg Empagliflozin in tablets once daily.
Empa 10 mg Patients receive 10 mg Empagliflozin in tablets once daily.
Empa 25 mg Patients receive 25 mg Empagliflozin in tablets once daily.
Empa 50 mg Patients receive 50 mg Empagliflozin in tablets once daily.
Sitag Patients receive 100 mg Sitagliptin (open-label) in tablets once daily.
Total Total of all reporting groups

Baseline Measures
   Placebo   Empa 1 mg   Empa 5 mg   Empa 10 mg   Empa 25 mg   Empa 50 mg   Sitag   Total 
Overall Participants Analyzed 
[Units: Participants]
 71   71   71   71   70   70   71   495 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.7  (8.5)   57.4  (8.8)   59.7  (7.3)   59.0  (9.0)   58.7  (8.1)   55.9  (9.4)   57.6  (10.1)   58.3  (8.8) 
Gender 
[Units: Participants]
               
Female   38   30   42   38   33   31   33   245 
Male   33   41   29   33   37   39   38   250 


  Outcome Measures

1.  Primary:   Change From Baseline in HbA1c After 12 Weeks of Treatment   [ Time Frame: Baseline and 12 weeks ]

2.  Secondary:   Change of FPG From Baseline After 12 Weeks of Treatment   [ Time Frame: Baseline and 12 weeks ]

3.  Secondary:   Change of HbA1c From Baseline Over Time   [ Time Frame: Baseline and weeks 4, 8 and 12 ]

4.  Secondary:   Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment   [ Time Frame: Baseline and 12 weeks ]

5.  Secondary:   Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment   [ Time Frame: Baseline and 12 weeks ]

6.  Secondary:   Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)   [ Time Frame: Baseline and 12 weeks ]

7.  Secondary:   Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)   [ Time Frame: Baseline and 12 weeks ]

8.  Secondary:   Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)   [ Time Frame: Baseline and 12 weeks ]

9.  Secondary:   Change of Body Weight After 12 Weeks of Treatment   [ Time Frame: Baseline and 12 weeks ]

10.  Secondary:   Trough Concentrations of Empagliflozin in Plasma   [ Time Frame: Days 28, 56 and 84 ]


  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, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00749190     History of Changes
Other Study ID Numbers: 1245.10
EudraCT 2008-000641-54
First Submitted: September 8, 2008
First Posted: September 9, 2008
Results First Submitted: May 16, 2014
Results First Posted: June 13, 2014
Last Update Posted: June 13, 2014