| Outcome Measures: |
Primary: Change From Baseline in HbA1c at the End of Treatment Period I, Baseline (Week 0) and end of Treatment Period I (Up to Week 12)|Number of Participants Who Had One or More Treatment Emergent Adverse Event (TEAE) Before the Start of Study Drug Administration in Treatment Period II, An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a drug (including the study drug). It does not necessarily have to have a causal relationship with this treatment (including the study drug). An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug (including the study 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. Reported data is the number of participants reporting one or more TEAEs that occurred before the start of Treatment Period II in each group., Up to Week 12|Number of Participants Who Had One or More TEAE Occurred After 1st Dose of Trelagliptin 25 mg Tablet, An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a drug (including the study drug). It does not necessarily have to have a causal relationship with this treatment (including the study drug). An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug (including the study drug), whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. As to collect the safety data of long-term treatment with the active drug widely, the number of participants reporting one or more TEAEs that occurred after 1st dose of trelagliptin 25 mg, that is events in Period I and II for "Trelagliptin 25 mg" group and events in Period II for "Placebo and Trelagliptin 25 mg" group, was analyzed., Up to Week 54 | Secondary: Changes From Baseline in HbA1c, Reported data was the change from baseline in HbA1c at each time point., Baseline (Week 0) and Week 2, 4, 8, 12, and End of Treatment Period I (up to Week 12) and Period II (up to Week 52)|Number of Participants Achieving <6.0%, <7.0%, and <8.0% HbA1c at the End of Treatment Period I and Period II, At the end of Treatment Period I (Up to Week 12) and Period II (Up to Week 52)|Change From Baseline in Fasting Plasma Glucose, Reported data was the change from baseline in fasting plasma glucose at each time point., Baseline (Week 0) and Week 2, 4, 8, 12, and End of Treatment Period I (up to Week 12) and Period II (up to Week 52)|Change From Baseline in Glycoalbumin, Reported data was the change from baseline in glycoalbumin at each time point., Baseline (Week 0) and Week 2, 4, 8, 12, and End of Treatment Period I (up to Week 12) and Period II (up to Week 52)|Numbers of Participants With TEAE Related to Vital Signs Before the Start of Study Drug Administration in Treatment Period II, Number of participants with a vital sign-related TEAE classified under the System Organ Class of "investigations," was reported., Up to Week 12|Number of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters Before the Start of Study Drug Administration in Treatment Period II, Here "QTcF" is corrected QT interval by Fridericia formula., Up to Week 12|Number of Participants With Markedly Abnormal Values of Clinical Laboratory Parameters Before the Start of Study Drug Administration in Treatment Period II, Here "U/L" is Unit/Litter, and "ULN" is Upper Limit of Normal., Up to Week 12
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| Locations: |
Anjo, Aichi, Japan|Kasukabe, Aichi, Japan|Nagoya, Aichi, Japan|Toyohashi, Aichi, Japan|Yatomi, Aichi, Japan|Asahi, Chiba, Japan|Kisarazu, Chiba, Japan|Yotsukaido, Chiba, Japan|Imabari, Ehime, Japan|Matsuyama, Ehime, Japan|Niihama, Ehime, Japan|Chikushino, Fukuoka, Japan|Kasuga, Fukuoka, Japan|Kasuya-gun, Fukuoka, Japan|Kitakyushu, Fukuoka, Japan|Munakata, Fukuoka, Japan|Tajimi, Gifu, Japan|Takasaki, Gunma, Japan|Fukuyama, Hiroshima, Japan|Chitose, Hokkaido, Japan|Himeji, Hyogo, Japan|Takarazuka, Hyogo, Japan|Mito, Ibaragi, Japan|Sakai, Ibaragi, Japan|Fujisawa, Kanagawa, Japan|Kamakura, Kanagawa, Japan|Kawasaki, Kanagawa, Japan|Yokohama, Kanagawa, Japan|Sendai, Miyagi, Japan|Nakano, Nagano, Japan|Ueda, Nagano, Japan|Kasaoka, Okayama, Japan|Setouchi, Okayama, Japan|Fukaya, Saitama, Japan|Kumagaya, Saitama, Japan|Hamamatsu, Shizuoka, Japan|Yoshinogawa, Tokushima, Japan|Hachioji, Tokyo, Japan|Itabashi-ku, Tokyo, Japan|Kunitachi, Tokyo, Japan|Uozu, Toyama, Japan|Shimonoseki, Yamaguchi, Japan|Ube, Yamaguchi, Japan|Akita, Japan|Kumamoto, Japan|Nagano, Japan|Niigata, Japan|Osaka, Japan|Yamagata, Japan
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