Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The objective of the study is to investigate the long-term safety and efficacy of BI 10773 given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Official Title
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A 52-week, Randomised, Multi-centre, Parallel Group Study to Investigate the Safety and Efficacy of BI 10773 (10 mg or 25 mg Administered Orally Once Daily) as add-on Therapy to an Oral Antidiabetic Drug (Sulfonylurea, Biguanide, Thiazolidinedione, Alpha Glucosidase Inhibitor, DPP-IV Inhibitor, or Glinide) in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Metformin
* Drug: BI 10773
* Drug: Placebo (low dose)
* Drug: BI 10773
* Drug: Placebo (high dose)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: .Diagnosis of type 2 diabetes mellitus prior to informed consent Male and female patients, on diet and exercise regimen, who are pre-treated with one of the following oral antidiabetic drugs: sulfonylurea, glinide, biguanide, Alpha-glucosidase inhibitor (a-GI), dipeptidyl peptidase-IV (DPP-IV) inhibitor or thiazolidinedione glycosylated haemoglobin (HbA1c) at Visit 1: >=7.0 to =<10.0% (national glycohemoglobin standardization program) Exclusion criteria: Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L) Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)

Ages Eligible for Study
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Minimum Age: 20 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 low dose<br>BI 10773 low dose tablet once daily | Drug: BI 10773<br>* BI 10773 low dose tablet once daily<br>Drug: Placebo (high dose)<br>* Placebo tablets once daily<br>|
| Experimental: BI 10773 high dose<br>BI 10773 high dose tablet once daily | Drug: Placebo (low dose)<br>* Placebo tablets once daily<br>Drug: BI 10773<br>* BI 10773 high dose tablet once daily<br>|
| Active Comparator: Metformin<br>Metformin tablets 500-2250 mg a day (twice or three times per day) | Drug: Metformin<br>* Metformin tablets 500-2250 mg a day (twice or three times per day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Drug Related Adverse Events | Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days | After the first drug intake until 7 days after the last treatment administration, up to 383 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c | Change from baseline in HbA1c after 52 weeks of treatment | Baseline and 52 weeks |