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

Study Overview
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Brief Summary
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This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.

Official Title
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A Phase III Randomised, Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 10773 Compared to Glimepiride Administered Orally During 104 Weeks With a 104 Week Extension Period in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Metformin Treatment

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: BI 10773
* Drug: Glimepiride
* Drug: Placebo
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Diagnosis typ 2 diabetes mellitus Male and female on diet and exercise regimen, pre-treated with metformin 12 weeks prior to randomisation HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1 18 years or more BMI equal or less than 45Kg/m2 Exclusion criteria: Uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in Any other antidiabetic drug within 12 weeks prior to randomisation except metformin Acute coronary syndrome (non-STEMI, STEMI unstable angina pectoris), stroke or transient ischemic attack within 12 weeks of informed consent Indication of liver disease Moderate to severe renal impairment Bariatric surgery within past 2 years Medical history of cancer or treatment for cancer within last 5 years Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell Contraindications hypersensitivity to concomitant drugs Treatment with anti-obesity drugs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 10773 dose plus metformin<br>Patients receive one BI10773 tablet and one placebo Glimepiride capsule once daily | Drug: BI 10773<br>* Medium dose once daily<br>Drug: Placebo<br>* Placebo matching Glimepiride<br>|
| Active Comparator: Glimepiride 1-4 mg plus metformin<br>Patients receive one glimepiride capsule and one placebo tablet Bi 10773 once daily. | Drug: Glimepiride<br>* 1-4 mg once daily<br>Drug: Placebo<br>* Placebo matching BI 10773<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment. |  | Baseline and 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change in Body Weight From Baseline After 104 Weeks of Treatment. |  | baseline and 104 weeks | 
| The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment. |  | baseline and 104 weeks | 
| The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment. |  | baseline and 104 weeks | 
| The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment. |  | baseline and 104 weeks | 
| The Change From Baseline in HbA1c After 52 Weeks of Treatment. |  | baseline and 52 weeks | 
| The Change in Body Weight From Baseline After 52 Weeks of Treatment. |  | baseline and 52 weeks | 
| The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment. |  | baseline and 52 weeks | 
| The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment. |  | baseline and 52 weeks | 
| The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment. |  | baseline and 52 weeks |