| Outcome Measures: |
Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs), An TEAE is any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have a causal relationship with this treatment. A serious TEAE is defined as any untoward medical occurrence that resulted in death, was life threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, led to a congenital anomaly/birth defect or was an important medical event that may have required intervention to prevent any of items above., 52 Weeks | Secondary: Change From Baseline in Glycosylated Hemoglobin (HbA1c), The change in the value of glycosylated hemoglobin collected at Week 52 or at the final visit relative to Baseline., Baseline and Week 52|Percentage of Participants With a Clinical Response, Clinical response is defined as an HbA1c level less than 5.8% or less than 6.5% at Week 52 or at the final visit., Week 52|Change From Baseline in Fasting Glucose, The change in the value of fasting glucose collected at Week 52 or the final visit relative to Baseline., Baseline and Week 52
|
| Locations: |
Nagoya-shi, Aichi, Japan|Fukuoka-shi, Fukuoka, Japan|Kurume-shi, Fukuoka, Japan|Sapporo-shi, Hokkaido, Japan|Kobe-shi, Hyogo, Japan|Kagoshima-shi, Kagoshima, Japan|Kumamoto-shi, Kumamoto, Japan|Osaki-shi, Miyagi, Japan|Minou-shi, Osaka, Japan|Osaka-shi, Osaka, Japan|Kamio-shi, Saitama, Japan|Koshigaya-shi, Saitama, Japan|Adachi-ku, Tokyo, Japan|Chuo-ku, Tokyo, Japan
|
