| Outcome Measures: |
Primary: Change from baseline in HbA1c, Baseline and Week 24 (end of treatment period 1) | Secondary: Change from baseline in HbA1c, Baseline and up to Week 56|Change from baseline in Fasting plasma glucose, Baseline and up to Week 56|Change from baseline in self-monitored blood glucose level, Baseline and up to Week 56|Change from baseline in leptin, Baseline and up to Week 52|Change from baseline in glycoalbumin, Baseline and up to Week 52|Change from baseline in adiponectin, Baseline and up to Week 52|Change from baseline in glucagon, Baseline and up to Week 52|Change from baseline in number of units of insulin administered concomitantly, Comprehensively assessed by basal insulin daily dose, bolus insulin daily dose and total insulin daily dose., Baseline and up to Week 56|Change from baseline in body weight, Baseline and up to Week 56|Change from baseline in waist circumference, Baseline and up to Week 52|Safety assessed by incidence of adverse events, Up to Week 56|Safety assessed by sitting blood pressure, Up to Week 56|Safety assessed by sitting pulse rate, Up to Week 56|Safety assessed by standard 12-lead electrocardiogram, Up to Week 56|Safety assessed by laboratory tests: Hematology, Up to Week 56|Safety assessed by laboratory tests: Biochemistry, Up to Week 56|Safety assessed by laboratory tests: Urinalysis, Up to Week 56
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| Locations: |
Site JP00005, Aichi, Japan|Site JP00028, Aichi, Japan|Site JP00003, Chiba, Japan|Site JP00013, Chiba, Japan|Site JP00035, Chiba, Japan|Site JP00022, Fukuoka, Japan|Site JP00023, Fukuoka, Japan|Site JP00031, Fukuoka, Japan|Site JP00002, Gunma, Japan|Site JP00011, Gunma, Japan|Site JP00006, Hiroshima, Japan|Site JP00033, Hokkaido, Japan|Site JP00034, Hokkaido, Japan|Site JP00021, Hyogo, Japan|Site JP00009, Ibaraki, Japan|Site JP00010, Ibaraki, Japan|Site JP00004, Kanagawa, Japan|Site JP00015, Kanagawa, Japan|Site JP00016, Kanagawa, Japan|Site JP00019, Mie, Japan|Site JP00008, Nagasaki, Japan|Site JP00024, Nagasaki, Japan|Site JP00025, Nagasaki, Japan|Site JP00032, Nagasaki, Japan|Site JP00026, Niigata, Japan|Site JP00020, Osaka, Japan|Site JP00029, Osaka, Japan|Site JP00036, Osaka, Japan|Site JP00012, Saitama, Japan|Site JP00017, Shizuoka, Japan|Site JP00018, Shizuoka, Japan|Site JP00001, Tochigi, Japan|Site JP00030, Tokushima, Japan|Site JP00014, Tokyo, Japan|Site JP00027, Toyama, Japan|Site JP00007, Yamaguchi, Japan
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