Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus

A Double-blind, Randomised, Parallel Group Efficacy and Safety Study of BI 10773 (5 mg, 10 mg, 25 mg, and 50 mg) Compared to Placebo When Administered Orally Once Daily Over 12 Weeks, as Monotherapy, in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Diet and Exercise, Followed by a 40 Week Randomised Extension Study to Assess Long Term Safety of BI 10773 (10 mg and 25 mg)

This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in Japanese patients with T2DM at first treatment period. The second treatment period is required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese patients with T2DM according to the ICH E1 guideline.

Inclusion criteria:

• Diagnosis of type 2 diabetes mellitus prior to informed consent

• Male and female patients on diet and exercise regimen who are:

  1. drug-naïve, defined as no antidiabetic drugs for 10 weeks prior to informed consent.
  2. pre-treated with one oral antidiabetic drug; the present antidiabetic therapy has to be unchanged for 10 weeks prior to informed consent.

• HbA1c at Visit 1a:

  1. for patients who are drug naïve: HbA1c >=7.0 to =<10.0%
  2. for patients treated with one oral antidiabetic drug: HbA1c >=6.5 to =<9.0%

• HbA1c of >=7.0% and =<10% at Visit 2 (start of run-in)

Exclusion criteria:

• Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L) after an overnight fast during wash-out/placebo run-in period and confirmed by a second measurement (not on the same day).
• Acute coronary syndromes, stroke or transient ischaemic attack within 12 weeks prior to informed consent
• Impaired renal function, defined as calculated eGFR <60 ml/min (MDRD formula) during screening and/or wash-out period and/or run-in phase.
• Bariatric surgery within the past 2 years and other gastrointestinal surgeries that induce chronic malabsorption
• Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
• Treatment with anti-obesity drugs (e.g. sibutramine, mazindol) 12 weeks prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight