Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01167881
First received: July 15, 2010
Last updated: July 17, 2014
Last verified: July 2014
Results First Received: July 17, 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: BI 10773
Drug: Glimepiride
Drug: Placebo

  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
Empaglifozin 25 mg

Patients receive one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule once daily

Empagliflozin: 25 mg once daily

Placebo: Placebo matching Glimepiride

Glimepiride

Patients receive one Glimepiride capsule and one placebo Empagliflozin tablet once daily.

Glimepiride: 1-4 mg once daily

Placebo: Placebo matching Empagliflozin


Participant Flow:   Overall Study
    Empaglifozin 25 mg     Glimepiride  
STARTED     769     780  
COMPLETED     676     686  
NOT COMPLETED     93     94  
Not treated                 4                 0  
Lost to Follow-up                 19                 19  
Withdrawal by Subject                 57                 62  
Death                 4                 4  
Reason not defined above                 9                 9  



  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), All patients randomised, treated with at least one dose of study drug, and with a baseline HbA1c value.

Reporting Groups
  Description
Empaglifozin 25 mg

Patients receive one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule once daily

Empagliflozin: 25 mg once daily

Placebo: Placebo matching Glimepiride

Glimepiride

Patients receive one Glimepiride capsule and one placebo Empagliflozin tablet once daily.

Glimepiride: 1-4 mg once daily

Placebo: Placebo matching Empagliflozin

Total Total of all reporting groups

Baseline Measures
    Empaglifozin 25 mg     Glimepiride     Total  
Number of Participants  
[units: participants]
  765     780     1545  
Age  
[units: years]
Mean ± Standard Deviation
  56.2  ± 10.3     55.7  ± 10.4     55.9  ± 10.4  
Gender  
[units: participants]
     
Female     333     359     692  
Male     432     421     853  



  Outcome Measures
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1.  Primary:   The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.   [ Time Frame: Baseline and 104 weeks ]

2.  Secondary:   The Change in Body Weight From Baseline After 104 Weeks of Treatment.   [ Time Frame: baseline and 104 weeks ]

3.  Secondary:   The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment.   [ Time Frame: baseline and 104 weeks ]

4.  Secondary:   The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment.   [ Time Frame: baseline and 104 weeks ]

5.  Secondary:   The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment.   [ Time Frame: baseline and 104 weeks ]

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

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

8.  Secondary:   The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment.   [ Time Frame: baseline and 52 weeks ]

9.  Secondary:   The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment.   [ Time Frame: baseline and 52 weeks ]

10.  Secondary:   The Change in Diastolic Blood Pressure (DBP) From Baseline 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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