Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients 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:
NCT01306214
First received: February 28, 2011
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
Conditions: Diabetes Mellitus, Type 2
Obesity
Interventions: Drug: Placebo
Drug: BI 10773

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
Empagliflozin 10 mg Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
Empagliflozin 25 mg Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily

Participant Flow:   Overall Study
    Placebo     Empagliflozin 10 mg     Empagliflozin 25 mg  
STARTED     189     187     190  
COMPLETED     161     159     168  
NOT COMPLETED     28     28     22  
Death                 0                 0                 1  
Lost to Follow-up                 3                 5                 4  
Withdrawal by Subject                 24                 22                 16  
Not treated                 1                 1                 1  



  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): FAS included all randomised and treated patients who had a baseline HbA1c value.

Reporting Groups
  Description
Placebo Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
Empagliflozin 10 mg Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
Empagliflozin 25 mg Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
Total Total of all reporting groups

Baseline Measures
    Placebo     Empagliflozin 10 mg     Empagliflozin 25 mg     Total  
Number of Participants  
[units: participants]
  188     186     189     563  
Age  
[units: years]
Mean ± Standard Deviation
  55.3  ± 10.1     56.7  ± 8.7     58.0  ± 9.4     56.7  ± 9.5  
Gender  
[units: participants]
       
Female     113     89     105     307  
Male     75     97     84     256  



  Outcome Measures
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1.  Primary:   Change From Baseline in HbA1c After 18 Weeks of Treatment   [ Time Frame: Baseline and 18 weeks ]

2.  Secondary:   Change From Baseline in Insulin Dose After 52 Weeks of Treatment   [ Time Frame: Baseline and 52 weeks ]

3.  Secondary:   Change From Baseline in Body Weight After 52 Weeks of Treatment   [ Time Frame: Baseline and 52 weeks ]

4.  Secondary:   Change From Baseline in HbA1c After 52 Weeks of Treatment   [ Time Frame: Baseline and 52 weeks ]


  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: NCT01306214     History of Changes
Other Study ID Numbers: 1245.49, 2010-019968-37
Study First Received: February 28, 2011
Results First Received: May 16, 2014
Last Updated: May 16, 2014
Health Authority: Belgium: Federal Agency for Medicinal and Health Products
Bulgaria: Bulgarian Drug Agency
Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Guatemala:
Mexico: Federal Commission for Protection Against Health Risks
Peru: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Spain: Spanish Agency of Medicines
Ukraine: State Pharmacological Center - Ministry of Health
United States: Food and Drug Administration