| Outcome Measures: |
Primary: Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) National Glycohemoglobin Standardization Program (NGSP) at the End of Treatment (EOT) Period, The change in the value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at End of Treatment Period relative to Baseline. A negative change from Baseline indicates improvement. An Analysis of Covariate (ANCOVA) model with change from Baseline as a dependent variable and Baseline and treatment as independent variables was used for main analyses., Baseline and End of Treatment (EOT) (Up to Week 24) | Secondary: Change From Baseline in HbA1c (NGSP), The change in the value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Weeks 2, 4, 8, 12, 16, 20, 24, and EOT relative to Baseline. A negative change from Baseline indicates improvement., Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)|HbA1c (NGSP), The value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and EOT., Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)|Percentage of Participants Achieving Target HbA1c (NGSP) Levels at the EOT Period, HbA1c (NGSP) is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound. The percentage of participants with HbA1c levels of ≥6.0, ≥7.0 and ≥8.0 at the end of Screening (Baseline) with change to target values \<6.0, \<7.0 and \<8.0 respectively at EOT., Baseline and EOT (Up to Week 24)|Change From Baseline in Fasting Blood Glucose, The change in the value of the fasting plasma glucose collected at Weeks 2, 4, 8, 12, 16, 20 and 24 relative to Baseline. A negative change from Baseline indicates improvement., Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)|Fasting Blood Glucose, The value of the fasting plasma glucose collected at Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT., Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)|Percentage of Participants With Treatment-Emergent Adverse Events (TEAE), An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug., 24 Weeks|Percentage of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis, The percentage of participants with any clinically relevant safety laboratory changes (chemistry, hematology and urinalysis) collected throughout study and recorded as AEs., 24 Weeks|Percentage of Participants With TEAEs Related to Vital Signs, Vital signs included sitting systolic and diastolic blood pressures (mmHg) (measured after resting for ≥ 5 minutes) and pulse rate (beats per minute \[bpm\])., 24 Weeks|Number of Participants Who Had Clinically Relevant Changes in 12-Lead Electrocardiogram (ECG) Findings, Number of participants who had ECG findings changed from "normal" or "abnormal but not clinically relevant" at Baseline to "abnormal and clinically relevant"., Baseline and Weeks 12 and 24
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| Locations: |
Nagoya-shi, Aichi, Japan|Chiba-shi, Chiba, Japan|Fukuoka-shi, Fukuoka, Japan|Kitakyushu-shi, Fukuoka, Japan|Kurume-shi, Fukuoka, Japan|Aki-gun, Hiroshima, Japan|Hiroshima-shi, Hiroshima, Japan|Koga-shi, Ibaraki, Japan|Mito-shi, Ibaraki, Japan|Tushiura-shi, Ibaraki, Japan|Ushiku-shi, Ibaraki, Japan|Kanazawa-shi, Ishikawa, Japan|Takamatsu-chi, Kagawa, Japan|Sendai-shi, Miyagi, Japan|Ohita-shi, Ohita, Japan|Okinawa-shi, Okinawa, Japan|Shimajiri-gun, Okinawa, Japan|Kashiwara-shi, Osaka, Japan|Osaka-shi, Osaka, Japan|Hiki-gun, Saitama, Japan|Oyama-shi, Tochigi, Japan|Shimotsuke-shi, Tochigi, Japan|Koutoh-ku, Tokyo, Japan|Meguro-ku, Tokyo, Japan|Sagae-shi, Yamagata, Japan|Yamagata-shi, Yamagata, Japan|Yamaguchi-shi, Yamaguchi, Japan
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