Post Prandial Glucose (PPG) Study of Empagliflozin in Japanese Patients With Type 2 Diabetes Mellitus

Inclusion criteria

• Diagnosis of type 2 diabetes mellitus prior to informed consent
• Male and female patients on diet and exercise regimen for 12 weeks prior to informed consent who are:

• drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to informed consent or,
• pre-treated with one oral antidiabetic drug (except sulfonylurea and thiazolidinedione); the present antidiabetic therapy has to be unchanged for at least 12 weeks prior to the informed consent. (Sulfonylurea is permitted as pre-treatment drug only if the dose is equal or less than a half of daily maximum approval dose.)
• Glycosylated haemoglobin (HbA1c) at Visit 1 (screening)

• for patients without antidiabetic therapy : HbA1c >=7.0 to =<10.0%
• for patients with one oral antidiabetic drug : HbA1c >=7.0 to =<9.5%

Exclusion criteria

• Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L)
• Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 (moderate and severe renal impairment, modification of diet in renal disease (MDRD) formula)
• 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)