| Outcome Measures: |
Primary: Change in HbA1c From Baseline at the End of Treatment Period I (End of Treatment Period I - End of the Screening Period), End of the screening period (Week 0) and End of Treatment Period I (Up to Week 12)|Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs) That Occurred Before Start of Treatment Period II, Reported data is the number of participants reporting one or more TEAEs that occurred before start of Treatment Period II in Treatment Group I and Treatment Group II., Up to Week 12 | Secondary: Change From Baseline in HbA1c, Reported data was the change from baseline in HbA1c at each time point., Baseline and Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, End of Treatment Period I (Up to Week 12) and End of Treatment Period II (Up to Week 52)|Change From Baseline in Fasting Plasma Glucose, Reported data was the change from baseline in fasting plasma glucose at each time point., Baseline and Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 53, End of Treatment Period I (Up to Week 12) and End of Treatment Period II (Up to Week 52)|Change From Baseline in Plasma Glucose Measured by the Meal Tolerance Test in Treatment Period I, Reported data was the change from pre-meal in plasma glucose measured by the meal tolerance test at each time point., Pre-meal and 0.5, 1, and 2 hr after-meal at Week 0 and 0.5, 1, and 2 hr after-meal at the End of Treatment Period I (Up to Week 12)|Number of Participants With Markedly Abnormal Values of Vital Signs Before Start of Treatment Period II, Here "mmHg" is Millimeter of mercury., Up to Week 12|Number of Participants With Markedly Abnormal Values of ECG Parameters Before Start of Treatment Period II, Here "QTcF" is Corrected QT interval by Fridericia formula, and "msec" is millisecond., Up to Week 12|Number of Participants With Markedly Abnormal Values of Laboratory Parameters (Total Bilirubin >2.0) Before Start of Treatment Period II, Up to Week 12|Number of Participants With Total Hypoglycaemia After 1st Dose of Study Drug and Before Start of Treatment Period II, Up to Week 53|Change From Baseline in Self-Monitoring of Blood Glucose Before Breakfast, Reported data was the change from baseline in self-monitoring of blood glucose before breakfast., Baseline and Day 2, 3, 4, 5, 6, 7, and 8 in each Treatment Period (I and II) (Totally up to Week 17)
|
| Locations: |
Nagoya, Aichi, Japan|Hirosaki, Aomori, Japan|Kurume, Fukuoka, Japan|Sapporo, Hokkaido, Japan|Koga, Ibaragi, Japan|Mito, Ibaragi, Japan|Naka, Ibaragi, Japan|Tsuchiura, Ibaragi, Japan|Ushiku, Ibaragi, Japan|Kanazawa, Ishikawa, Japan|Satsumakawauchi, Kagoshima, Japan|Chigasaki, Kanagawa, Japan|Fujisawa, Kanagawa, Japan|Sendai, Miyagi, Japan|Hirakata, Osaka, Japan|Kashiwara, Osaka, Japan|Suita, Osaka, Japan|Ageo, Saitama, Japan|Sangou, Saitama, Japan|Hamamatsu, Shizuoka, Japan|Shimada, Shizuoka, Japan|Koyama, Tochigi, Japan|Shimono, Tochigi, Japan|Chiyoda-ku, Tokyo, Japan|Nerima-ku, Tokyo, Japan|Shinjuku-ku, Tokyo, Japan|Suginami-ku, Tokyo, Japan|Tama, Tokyo, Japan|Shimonoseki, Yamaguchi, Japan|Shunann, Yamaguchi, Japan|Ageo, Japan|Aomori, Japan|Chiba, Japan|Chigasaki, Japan|Chiyoda-ku, Japan|Fujisawa, Japan|Fukuoka, Japan|Hamamatsu, Japan|Hirakata, Japan|Hirosaki, Japan|Kagoshima, Japan|Kanazawa, Japan|Kashiwara, Japan|Koga, Japan|Koyama, Japan|Kumamoto, Japan|Kurume, Japan|Kyoto, Japan|Mito, Japan|Nagoya, Japan|Naka, Japan|Nerima-ku, Japan|Osaka, Japan|Sangou, Japan|Satsumakawauchi, Japan|Sendai, Japan|Shimada, Japan|Shimonoseki, Japan|Shimono, Japan|Shinjuku-ku, Japan|Shizuoka, Japan|Suginami-ku, Japan|Tama, Japan|Toyama, Japan|Tsuchiura, Japan
|
