| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26, HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Pre-study oral antihyperglycemic medication (OAM) Group 1 + Treatment + Time + Treatment × Time as variables., Baseline, Week 26 | Secondary: Change From Baseline in HbA1c at Week 52, HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model with Baseline + Pre-study OAM Group 1 + Treatment + Time + Treatment × Time as variables., Baseline, Week 52|Percentage of Participants Achieving HbA1c Target ≤6.5% and <7.0%, HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. The odds ratios, confidence intervals, and p-values were determined by generalized linear mixed model (GLM) with Baseline + Pre-study OAM Group 1 + Treatment + Time + Treatment × Time as variables., Week 52|Change From Baseline in Fasting Serum Glucose (FSG), FSG is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment + Time + Treatment\*Time as variables., Baseline, Week 52|Change From Baseline in 6-point Self-Monitored Blood Glucose (SMBG), SMBG 6-point profiles were measured at morning (premeal-fasting, 2-hour post meal), midday (premeal, 2-hour post meal), and evening (premeal, 2-hour post meal). LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment as variables., Baseline, Week 26|Change From Baseline in Body Weight, LS mean was determined by MMRM model with Baseline + Baseline HbA1c (High, Low) Group, OAM-based + Pre-study OAM Group 1 + Treatment + Time + Treatment\*Time as variables., Baseline, Week 52
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| Locations: |
Tosaki Clinic for Diabetes and Endocrinology, Nagoya-shi, Aichi, 468-0009, Japan|Nakayama Clinic, Nagoya, Aichi, 456-0058, Japan|Kashiwa City Hospital, Kashiwa, Chiba, 277-0825, Japan|Kobari General Clinic, Noda, Chiba, 278-0004, Japan|Nippon Kokan Fukuyama Hospital, Fukuyama-shi, Hiroshima, 721-0927, Japan|Yamagata Naika Clinic, Asahikawa, Hokkaido, 078-8234, Japan|Hasegawa Medical Clinic, Chitose, Hokkaido, 066-0032, Japan|Yuri Ono Clinic, Sapporo, Hokkaido, 060-0001, Japan|Manda Memorial Hospital, Sapporo, Hokkaido, 060-0062, Japan|Miyanosawa Clinic of Internal Medicine and Cardiology, Sapporo, Hokkaido, 063-0826, Japan|Takabe Diabetes Clinic, Himeji, Hyogo, 670-0837, Japan|Nakamoto Internal Medicine Clinic, Mito, Ibaraki, 310-0826, Japan|Nakakinen clinic, Naka, Ibaraki, 311-0113, Japan|Nishiyamadou Keiwa Hospital, Naka, Ibaraki, 311-0133, Japan|Hayashi Diabetes Internal Medicine Clinic, Chigasaki, Kanagawa, 253-0044, Japan|Takai Internal Medicine Clinic, Kamakura-shi, Kanagawa, 247-0056, Japan|Shonan Takai Clinic, Kamakura, Kanagawa, 247-0055, Japan|Yamagishi Clinic Sagamiono, Sagamihara, Kanagawa, 252-0303, Japan|Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic, Yamato-shi, Kanagawa, 242-0004, Japan|Seiryo Internal Medicine, Iwanuma, Miyagi, 989-2451, Japan|Gibo Hepatology Clinic, Matsumoto, Nagano, 399-0036, Japan|Shiraiwa Medical Clinic, Kashiwara, Osaka, 582-0005, Japan|Medical Corporation Heishinkai OCROM Clinic, Suita-shi, Osaka, 565-0853, Japan|Sugiura Internal Medicine Clinic, Soka, Saitama, 340-0034, Japan|Seiwa Clinic, Adachi-ku, Tokyo, 120-0011, Japan|Tokyo-Eki Center-building Clinic, Chuo-ku, Tokyo, 103-0027, Japan|Medical Corporation Chiseikai Tokyo Center Clinic, Chuo-ku, Tokyo, 103-0028, Japan|Fukuwa Clinic, Chuo-ku, Tokyo, 104-0031, Japan|Hachioji Diabetes Clinic, Hachioji, Tokyo, 192-0083, Japan|Minamino Cardiovascular Hospital, Hachioji, Tokyo, 192-0918, Japan|Nomura Clinic, Itabashi, Tokyo, 173-0004, Japan|Yutenji Medical Clinic, Meguro-ku, Tokyo, 153-0053, Japan|Kanno Naika, Mitaka, Tokyo, 181-0013, Japan|Heishinkai Medical Group ToCROM Clinic, Shinjuku-ku, Tokyo, 160-0008, Japan|Futata Tetsuhiro Clinic, Fukuoka, 810-0006, Japan|Yoshimura Clinic, Kumamoto, 861-8039, Japan|Jinnouchi Hospital, Kumamoto, 862-0976, Japan|Heiwadai Hospital, Miyazaki, 880-0034, Japan|Ota Diabetes Internal Medicine Clinic, Nagano, 380-0802, Japan|Abe Clinic, Oita, 870-0039, Japan|AMC Nishiumeda Clinic, Osaka, 530-0001, Japan|Kitada Clinic, Osaka, 538-0044, Japan|Osaka Metropolitan Univ Hosp, Osaka, 545-8586, Japan|Nanko Clinic, Osaka, 559-0011, Japan
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