Dataset from 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.

本研究旨在明确日本2型糖尿病(Type 2 Diabetes Mellitus, T2DM)患者首个治疗周期中BI 10773的最适宜治疗剂量。根据ICH E1指南要求，需设置第二个治疗周期，以获取日本2型糖尿病患者使用BI 10773满一年的充分安全性数据。