| Outcome Measures: |
Primary: HbA1c change at Week 24 of the treatment from baseline, With regard to the HbA1c change at Week 24 of the treatment from baseline, changes will be shown by patient, as well as summarizing with the size of sample, mean, standard deviation, minimum, median, and maximum., at Week 24 of the treatment from baseline | Secondary: HbA1c change rate at Week 24 of the treatment from baseline, With regard to the HbA1c change rate at Week 24 of the treatment from baseline, change rates will be shown by patient, as well as summarizing with the size of sample, mean, standard deviation, minimum, median, and maximum., at Week 24 of the treatment from baseline|HbA1c change at Week 12 of the treatment from baseline, With regard to the HbA1c change at Week 12 of the treatment from baseline, changes will be shown by patient, as well as summarizing with the size of sample, mean, standard deviation, minimum, median, and maximum., at Week 12 of the treatment from baseline|HbA1c over time, The HbA1c level at measurement time point is tabulated by patient, as well as plotting the HbA1c level over time by line graph. In addition, the mean, standard deviation, interquartile range, minimum, median, and maximum of HbA1c at each time point will be calculated and tabulated, as well as displaying the mean at each measurement time point with error bar of standard deviation by line graph., at Week 24 of the treatment from baseline|Fasting plasma glucose (FPG) over time, The FPG level at measurement time point is tabulated by patient, as well as plotting the FPG level over time by line graph. In addition, the mean, standard deviation, interquartile range, minimum, median, and maximum of FPG at each time point will be calculated and tabulated, as well as displaying the mean at each measurement time point with error bar of standard deviation by line graph., at Week 24 of the treatment from baseline|FPG change at Week 24 of the treatment from baseline, With regard to the FPG change at Week 24 of the treatment from baseline, changes will be shown by patient, as well as summarizing with the size of sample, mean, standard deviation, minimum, median, and maximum., at Week 24 of the treatment from baseline|Change of insulin dose, The insulin dose of each patient will be tabulated by time point., at Week 24 of the treatment from baseline|Postprandial glucose for 2 hours over time, The postprandial glucose for 2 hours at measurement time point is tabulated by patient, and the glucose level over time is plotted by line graph. In addition, the mean, standard deviation, interquartile range, minimum, median, and maximum of postprandial glucose for 2 hours at each time point will be tabulated, and the mean at each measurement time point with an error bar of standard deviation will be displayed by line graph., 2 Weeks from Day0 and Day140
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| Locations: |
Kobe University Hospital, Kobe, Hyogo, 650-0017, Japan|Tohoku University Hospital, Sendai, Miyagi, 980-8574, Japan|Jichi Medical University Hospital, Shimotsuke, Tochigi, 329-0498, Japan|NIhon University Hospital, Chiyoda-ku, Tokyo, 101-8309, Japan|Okayama University Hospital, Okayama, 700-8558, Japan
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