| Outcome Measures: |
Primary: Adverse events, Adverse drug reactions, and Presence/absence of the use of rescue treatment drugs, Presence/absence of adverse events, adverse drug reactions, and use of rescue treatment drugs, until Week 28 (Week 52 of the EMPIRE-01 study) | Secondary: HbA1c change rate at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline, The HbA1c change rate at Week 28 (52) from baseline is defined as HbA1c change from baseline divided by baseline HbA1c of the EMPIRE-01 study and multiplied by 100., at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline|HbA1c change at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline, The HbA1c change at Week 28 (52) of the treatment from baseline is defined as the difference in HbA1c levels between Week 28 (52) and baseline of the EMPIRE-01 study., at Week 28 (Week 52 of the EMPIRE-01 study) of the treatment from baseline|HbA1c at each time point, The HbA1c at each time point is defined as the HbA1c levels at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation., at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation.|Fasting plasma glucose (FPG) at each time point, The FPG at each time point is defined as the FPG levels at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation., at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation.|Fasting plasma glucose (FPG) change at Week 28 (52) of the treatment from baseline, The FPG change at Week 28 (52) of the treatment from baseline is defined as the difference in the FPG levels between Week 28 (52) and baseline of the EMPIRE-01 study., between Week 28 (52) and baseline of the EMPIRE-01 study.|Insulin dose at each time point (TDD, TBD), The TDD and TBD at each time point are defined as the insulin doses at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation., at baseline of the EMPIRE-01 study, Week 12 (36), Week 28 (52), or at discontinuation.|Postprandial glucose for 2 hours over time, Postprandial glucose for 2 hours shall be measured for 14 days starting from Week 12 (36) by using FreeStyle Librae ProTM., for 14 days starting from Week 12 (36)
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| Locations: |
Kobe University Hospital, Kobe, Hyogo, 650-0017, Japan|Tohoku University Hospita, 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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