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

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ClinicalTrials.gov Identifier: NCT01167881
Recruitment Status : Completed
First Posted : July 22, 2010
Results First Posted : August 8, 2014
Last Update Posted : September 2, 2016
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: BI 10773
Drug: Glimepiride
Drug: Placebo

  Participant Flow

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
An optional 2-year extension was implemented in this trial through a protocol amendment, which brought the total length of treatment to 4 years. However, some sites did not participate in the 2-year extension, and so considered patients to have completed treatment after 2 years.

Reporting Groups
  Description
Empaglifozin 25 mg

Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.

Empagliflozin: 25 mg once daily

Placebo: Placebo matching Glimepiride

Glimepiride

Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.

Glimepiride: 1-4 mg once daily

Placebo: Placebo matching Empagliflozin


Participant Flow:   Overall Study
    Empaglifozin 25 mg   Glimepiride
STARTED   769   780 
Completed After 2 Years Treatment   95   127 
Completed After 4 Years Treatment   515   462 
COMPLETED   610   589 
NOT COMPLETED   159   191 
Adverse Event                47                51 
Lack of Efficacy                4                7 
Non compliant with protocol                9                18 
Lost to Follow-up                19                20 
Patient refusal to cont., not due to AE                45                40 
Not treated                4                0 
Other not defined above                31                55 



  Baseline Characteristics

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 received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.

Empagliflozin: 25 mg once daily

Placebo: Placebo matching Glimepiride

Glimepiride

Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally 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 
Overall Participants Analyzed 
[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

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

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
It should be noted that not all patients were followed up for 4 years with regard to the frequencies of adverse events presented up to 4 years.


  More Information