A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01649297
First received: July 23, 2012
Last updated: June 26, 2015
Last verified: June 2015
Results First Received: June 26, 2015  
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
Drug: empagliflozin (low dose qd)
Drug: Empagliflozin (high dose qd)
Drug: empagliflozin (high dose bid)
Drug: empagliflozin (low dose bid)

  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
Empa 12.5mg BID Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
Empa 25mg QD Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
Empa 5mg BID Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
Empa 10mg QD Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
Placebo Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg

Participant Flow:   Overall Study
    Empa 12.5mg BID     Empa 25mg QD     Empa 5mg BID     Empa 10mg QD     Placebo  
STARTED     219 [1]   218 [1]   219 [1]   220 [1]   107 [1]
COMPLETED     205     205     202     201     103  
NOT COMPLETED     14     13     17     19     4  
Adverse Event                 5                 5                 4                 13                 1  
Lack of Efficacy                 0                 0                 0                 0                 1  
Non compliant with Protocol                 1                 0                 3                 2                 1  
Lost to Follow-up                 1                 1                 4                 3                 0  
Patient withdrawal (not due to AE)                 3                 6                 4                 1                 1  
For other reason                 4                 1                 2                 0                 0  
[1] randomised



  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 being defined as all patients randomised, treated with at least one dose of study drug, had a baseline Glycosylated Haemoglobin (HbA1c) and at least one on-treatment HbA1c assessment.

Reporting Groups
  Description
Empa 12.5mg BID Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
Empa 25mg QD Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
Empa 5mg BID Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
Empa 10mg QD Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
Placebo Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
Total Total of all reporting groups

Baseline Measures
    Empa 12.5mg BID     Empa 25mg QD     Empa 5mg BID     Empa 10mg QD     Placebo     Total  
Number of Participants  
[units: participants]
  215     214     215     214     107     965  
Age  
[units: years]
Mean (Standard Deviation)
  57.6  (9.9)     58.2  (10.2)     58.8  (9.8)     58.5  (10.8)     57.9  (11.2)     58.2  (10.3)  
Gender  
[units: participants]
           
Female     92     100     95     106     52     445  
Male     123     114     120     108     55     520  



  Outcome Measures
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1.  Primary:   HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16   [ Time Frame: Baseline and 16 weeks ]

2.  Secondary:   Fasting Plasma Glucose (FPG) Change From Baseline at Week 16   [ Time Frame: Baseline and 16 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
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01649297     History of Changes
Other Study ID Numbers: 1276.10, 2012-000905-53
Study First Received: July 23, 2012
Results First Received: June 26, 2015
Last Updated: June 26, 2015
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