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

• Frequency of number of adverse events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
• Frequency of hypoglycaemic events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
• Frequency of protocol specified significant adverse events (decreased renal function and hepatic injury) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
• Frequency of cardiovascular events (defined based on adjudication results of clinical event committee) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
• Change from baseline in vital signs (blood pressure and pulse rate) [ Time Frame: Baseline and 52 weeks at the maximum ] [ Designated as safety issue: Yes ]
• Change from baseline in laboratory values [ Time Frame: Baseline and 52 weeks at the maximum ] [ Designated as safety issue: Yes ]

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.

• Drug: Metformin
  Metformin tablets 500-2250 mg a day (twice or three times per day)
• Drug: BI 10773
  BI 10773 low dose tablet once daily
• Drug: Placebo (low dose)
  Placebo tablets once daily
• Drug: BI 10773
  BI 10773 high dose tablet once daily
• Drug: Placebo (high dose)
  Placebo tablets once daily

• Experimental: BI 10773 low dose
  BI 10773 low dose tablet once daily
  Interventions:

  • Drug: BI 10773
  • Drug: Placebo (high dose)
• Experimental: BI 10773 high dose
  BI 10773 high dose tablet once daily
  Interventions:

  • Drug: Placebo (low dose)
  • Drug: BI 10773
• Active Comparator: Metformin
  Metformin tablets 500-2250 mg a day (twice or three times per day)
  Intervention: Drug: Metformin

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)