Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01177813
First received: July 29, 2010
Last updated: May 16, 2014
Last verified: May 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 identical to BI10773 high dose
Drug: BI 10773
Drug: BI 10773 open label
Drug: Placebo identical to BI10773 low dose
Drug: Placebo identical to Sitagliptin 100mg
Drug: BI10773
Drug: Sitagliptin

  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 Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
Empagliflozin10 mg Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
Empagliflozin 25 mg Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
Sitagliptin 100 mg Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
Empagliflozin 25 mg OL Patients receive 25 mg Empagliflozin in tablets open label (OL) once daily in the morning.

Participant Flow:   Overall Study
    Placebo     Empagliflozin10 mg     Empagliflozin 25 mg     Sitagliptin 100 mg     Empagliflozin 25 mg OL  
STARTED     228     224     224     223     87  
COMPLETED     187     206     204     206     78  
NOT COMPLETED     41     18     20     17     9  
Adverse Event                 8                 2                 4                 6                 3  
Lack of Efficacy                 1                 0                 0                 0                 0  
Protocol Violation                 3                 2                 2                 0                 1  
Lost to Follow-up                 12                 5                 6                 3                 0  
Withdrawal by Subject                 12                 7                 6                 5                 3  
Other reason not defined above                 5                 2                 2                 3                 2  



  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.
Full analysis set (FAS) including all randomised and treated patients who had a baseline HbA1c value (non-open label groups) and Open-label set including all patients entered in the empagliflozin 25 mg open-label treatment arm.

Reporting Groups
  Description
Placebo Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
Empagliflozin10 mg Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
Empagliflozin 25 mg Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
Sitagliptin 100 Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
Empagliflozin 25 mg OL Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
Total Total of all reporting groups

Baseline Measures
    Placebo     Empagliflozin10 mg     Empagliflozin 25 mg     Sitagliptin 100     Empagliflozin 25 mg OL     Total  
Number of Participants  
[units: participants]
  228     224     224     223     87     986  
Age [1]
[units: years]
Mean ± Standard Deviation
  54.9  ± 10.9     56.2  ± 11.6     53.8  ± 11.6     55.1  ± 9.9     50.2  ± 11.3     55.0  ± 11.0  
Gender  
[units: participants]
           
Female     105     82     79     82     23     371  
Male     123     142     145     141     64     615  
[1] The descriptive statistics for Total refers to the 4 non-open label groups (Placebo, Empagliflozin 10mg and 25 mg, Sitagliptin)



  Outcome Measures
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1.  Primary:   Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks   [ Time Frame: Baseline and day 169 ]

2.  Secondary:   Change From Baseline to Week 24 in Body Weight   [ Time Frame: Baseline and day 169 ]

3.  Secondary:   Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP)   [ Time Frame: Baseline and week 24 ]

4.  Other Pre-specified:   Confirmed Hypoglycaemic Adverse Events   [ Time Frame: From first drug intake until 7 days after last medication intake, up to 219 days ]


  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: NCT01177813     History of Changes
Other Study ID Numbers: 1245.20, 2009-016243-20
Study First Received: July 29, 2010
Results First Received: May 16, 2014
Last Updated: May 16, 2014
Health Authority: Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
China: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
India: Drugs Controller General of India
Ireland: Irish Medicines Board
Japan: Ministry of Health, Labor and Welfare
Switzerland: Swissmedic
United States: Food and Drug Administration