| Outcome Measures: |
Primary: Change from baseline in insulin dose, Baseline and Week 24|Percent change from baseline in insulin dose, Baseline and Week 24 | Secondary: Change from baseline in insulin dose, Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20 and the last assessment during the treatment period (up to Week 24)|Percent change from baseline in insulin dose, Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20 and the last assessment during the treatment period (up to Week 24)|Change from baseline in HbA1c, Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)|Change from baseline in fasting plasma glucose, Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)|Change from baseline in cholesterol, Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)|Change from baseline in glycoalbumin, Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)|Change from baseline in leptin, Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)|Change from baseline in adiponectin, Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)|Change from baseline in glucagon, Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)|Change from baseline in C-peptide, Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)|Change from baseline in body weight, Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)|Change from baseline in waist circumference, Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)|Change from baseline in blood pressure, Baseline and Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and the last assessment during the treatment period (up to Week 24)|Change from baseline in DTSQ, DTSQ: Diabetes treatment satisfaction questionnaire, Baseline and Week 24 and the last assessment during the treatment period (up to Week 24)|Number of subjects achieving withdrawal of insulin therapy, Up to Week 24|Percent of subjects achieving withdrawal of insulin therapy, Up to Week 24|Safety assessed by incidence of Adverse events, Up to Week 24|Safety assessed by blood pressure in a sitting position, Up to Week 24|Safety assessed by pulse rate in a sitting position, Up to Week 24|Safety assessed by Hematology, Up to Week 24|Safety assessed by biochemistry, Up to Week 24
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| Locations: |
Site JP00007, Gunma, Japan|Site JP00008, Hiroshima, Japan|Site JP00009, Hyogo, Japan|Site JP00010, Kanagawa, Japan|Site JP00003, Mie, Japan|Site JP00004, Osaka, Japan|Site JP00015, Shiga, Japan|Site JP00002, Tochigi, Japan|Site JP00005, Tochigi, Japan|Site JP00013, Tochigi, Japan|Site JP00001, Tokyo, Japan|Site JP00006, Tokyo, Japan|Site JP00011, Tokyo, Japan|Site JP00012, Tokyo, Japan|Site JP00014, Tokyo, Japan
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