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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:
ClinicalTrials.gov Identifier:
NCT01649297
First Posted: July 25, 2012
Last Update Posted: July 23, 2015
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.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
Results First Submitted: June 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   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
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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
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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01649297     History of Changes
Other Study ID Numbers: 1276.10
2012-000905-53 ( EudraCT Number: EudraCT )
First Submitted: July 23, 2012
First Posted: July 25, 2012
Results First Submitted: June 26, 2015
Results First Posted: July 23, 2015
Last Update Posted: July 23, 2015