| Outcome Measures: |
Primary: Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level, Baseline, and 12 months after administration|Change in HbA1c Level, Baseline, 12 months after administration | Secondary: Occurrence of Deterioration of Diabetic Treatment Status, "Deterioration of diabetic treatment status" is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of \> 0.5%., Baseline, 12 months after administration|Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status, "Deterioration of diabetic treatment status" is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of \> 0.5%., Baseline, 3, 6, 12 months after administration|Percent Change in 1,5-AG Level, An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa, Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）|Change in HbA1c Level, Baseline, 3, 6 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）|Percent Change in Blood Glucose Level (Fasting), Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）|Change in Blood Glucose Level (Fasting), Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）|Percent Change in Insulin Level, An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa., Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）|Change From Baseline in Insulin Level, An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa, Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）|Frequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease), From the start of the treatment to the end of study treatment|Frequency of Serious Adverse Events (SAE), Up to 12 months|Percent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA), Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment|Percent Change in Non-HDL-C Level, Baseline, 3 and 6 months after administration, the end of starting dose and the end of study treatment|Percent Changes in Lipids and Inflammatory Marker (Hs-CRP) and Their Correlation, Correlation between percent changes in lipids (LDL-C, HDL-C, non-HDL-C, TG, non-HDL-C/HDL-C ratio, LDL-C/HDL-C ratio, TC and FFA) and inflammatory marker (hs-CRP), Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment|Rate of Patients Who Have Reached the Target LDL-C Level Specified in Japan Atherosclerosis Society Guidelines (JASGL) 2007, Percentage of participants achieving the target LDL-C levels \<100 mg/dL for participants with history of coronary artery diseases (CAD) and \<120 mg/dL for participants without history of CAD are presented., 3 months after administration, the end of starting dose and the end of study treatment|Change From Baseline in 1,5-AG Level, An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa, Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）
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| Locations: |
Hiramitsu Heart Clinic, Nagoya city, Aichi pref., Japan|Honjo Daiichi Hospital, Yurihonjo city, Akita pref., Japan|Iryouhoujin Syadan Yanagisawakai Yanagisawa Iin, Matsudo city, Chiba pref., Japan|Matsuno Medical Clinic, Iyo gun, Ehime pref., Japan|Ishite Matsumoto Naika Junkanki Clinic, Matsuyama city, Ehime pref., Japan|Ehime Medical CO OP Izumigawa Clinic, Niihama city, Ehime pref., Japan|Fukui Chuoh Clinic, Fukui city, Fukui pref., Japan|Fukuoka City Medical Association Hospital, Fukuoka city, Fukuoka pref., Japan|Matsumoto Clinic, Fukuoka city, Fukuoka pref., Japan|Saku Hospital, Fukuoka city, Fukuoka pref., Japan|Soejima Medical Clinic, Fukuoka city, Fukuoka pref., Japan|Takei's Clinic Internal Medicine, Fukuoka city, Fukuoka pref., Japan|Nakamura Cardiovascular Clinic, Itoshima city, Fukuoka pref., Japan|Morizono Naika, Kitakyushu city, Fukuoka pref., Japan|Seino Internal Medicine Clinic, Koriyama city, Fukushima pref., Japan|Kawade Iin, Gifu city, Gifu pref., Japan, Japan|Hashimoto Naika Clinic, Gifu city, Gifu pref., Japan|Iinuma Iin, Gifu city, Gifu pref., Japan|Ishimura Clinic, Gifu city, Gifu pref., Japan|Kawai Clinic, Gifu city, Gifu pref., Japan|Niimi Clinic, Gifu city, Gifu pref., Japan|Takai Clinic, Gifu city, Gifu pref., Japan|Kobayashi Internal Medicine, Kakamigahara city, Gifu pref., Japan|Horibe Clinic, Motosu city, Gifu pref., Japan|Kondo Cardiovascular Clinic, Ogaki, Gifu pref., Japan|Yoshida Naika, Ogaki, Gifu pref., Japan|Kogure Clinic, Maebashi city, Gunma pref., Japan|Nakano Clinic, Shibukawa city, Gunma pref., Japan|Yoshii Central Clinic, Takasaki city, Gunma pref., Japan|Shigenobu Clinic, Miyoshi city, Hiroshima pref., Japan|Takahashi Kiyohito Clinic, Hakodate city, Hokkaido pref., Japan|Hokuto Internal Medicine Clinic, Sapporo city, Hokkaido pref., Japan|Katsuya Clinic, Amagasaki city, Hyogo pref., Japan|Nakatani Hospital, Himeji city, Hyogo pref., Japan|Kosumo Clinic, Kako gun, Hyogo pref., Japan|Harima Clinic, Kakogawa, Hyogo pref., Japan|Kusunose Clinic, Kobe city, Hyogo pref., Japan|Yanagi Medical Clinic, Hakusan city, Ishikawa pref., Japan|Okyozuka Clinic, Ishikawa gun, Ishikawa pref., Japan|Doniwa Clinic, Kanazawa city, Ishikawa pref., Japan|Wakasa Medical Clinic, Kanazawa city, Ishikawa pref., Japan|Association Medical Corporation Neurology Internal Medicine Kanamori Clinic, Iwate gun, Iwate pref., Japan|Medical Corporation Kuon-kai Kamata Medical Clinic, Morioka city, Iwate pref., Japan|Kagawa Clinic, Marugame city, Kagawa pref., Japan|Hasegawa Outpatients Clinic for Cardiovascular Disease, Takamatsu city, Kagawa pref., Japan|Tempozan Naika Clinic, Kagoshima city, Kagoshima pref., Japan|Kashiwagi Clinic, Ayase city, Kanagawa pref., Japan|Hayashi Diabetes Clinic, Chigasaki city, Kanagawa pref., Japan|Takada Internal Medicine Clinic, Hiratsuka city, Kanagawa pref., Japan|Iroden Clinic, Kamakura city, Kanagawa pref., Japan|Nagasu Clinic, Kamakura city, Kanagawa pref., Japan|Kobayashi Hospital, Odawara city, Kanagawa pref., Japan|Hakuai Iin, Sagamihara city, Kanagawa pref., Japan|Yamamoto Clinic, Sagamihara city, Kanagawa pref., Japan|Arima Clinic, Yokohama city, Kanagawa pref., Japan|Kikuchi Clinic, Yokohama city, Kanagawa pref., Japan|Miho cho Cardiovascular Medical Clinic, Yokohama city, Kanagawa pref., Japan|Minamisawa Clinic, Yokohama city, Kanagawa pref., Japan|Shimokurata Heart Clinic, Yokohama city, Kanagawa pref., Japan|Yokohama Sotetsu Bldg. Clinic of Internal Medicine, Yokohama city, Kanagawa pref., Japan|Jinnouchi Clinic Diabetes Care Center, Kumamoto city, Kumamoto pref., Japan|Maki Cardiovascular Clinic, Kumamoto city, Kumamoto pref., Japan|Munakata Clinic, Kumamoto city, Kumamoto pref., Japan|Terao Hospital, Kumamoto city, Kumamoto pref., Japan|Higashi Diabetes and Cardiovascular Clinic, Tamana city, Kumamoto pref., Japan|Matsuo Clinic, Tamana city, Kumamoto pref., Japan|Miyagi Clinic Cardiovascular Medicine, Yatsushiro city, Kumamoto pref., Japan|Sawai Naika Iin, Kyotanabe city, Kyoto pref., Japan|Asamoto Internal Medical Clinic, Kyoto city, Kyoto pref., Japan|Ijinkai Takeda General Hospital, Kyoto city, Kyoto pref., Japan|Koseikai Clinic, Kyoto city, Kyoto pref., Japan|Sakabe International Clinic, Kyoto city, Kyoto pref., Japan|Takenaka Clinic, Kyoto city, Kyoto pref., Japan|Tegoshi Clinic, Kyoto city, Kyoto pref., Japan|Iwasaki Hospital, Tsu city, Mie pref., Japan|Ishikawa Clinic, Miyazaki city, Miyazaki pref., Japan|Yokota Naika, Miyazaki city, Miyazaki pref., Japan|Etou Clinic, Nichinan city, Miyazaki pref., Japan|Kawano Clinic, Nichinan city, Miyazaki pref., Japan|Yamaguchi Clinic, Nichinan city, Miyazaki pref., Japan|Hasegawa Clinic, Nakano city, Nagano pref., Japan|Nara Prefectural Gojo Hospital, Gojo city, Nara pref., Japan|Fujii Internal Medicine Clinic, Kashihara city, Nara pref., Japan|Matsuoka Clinic, Kita katsuragi gun, Nara pref., Japan|Ote Clinic of Internal, Sakurai city, Nara pref., Japan|Uchiyama Clinic, Joetsu city, Niigata pref., Japan|Inoue Clinic, Niigata city, Niigata pref., Japan|Maeda Medical Clinic, Niigata city, Niigata pref., Japan|Nishimura Clinic, Fujiidera city, Osaka pref., Japan|Shoseikai Matsuda Iin, Fujiidera city, Osaka pref., Japan|Ikeda Clinic, Higashiosaka city, Osaka pref., Japan|Kanazawa Clinic, Izumi city, Osaka pref., Japan|Fukuda Clinic, Osaka city, Osaka pref., Japan|Jikuhara Clinic, Osaka city, Osaka pref., Japan|Kawagishi-naika Clinic, Osaka city, Osaka pref., Japan|Kinugawa Cardiology Clinic, Osaka city, Osaka pref., Japan|Kubota Clinic, Osaka city, Osaka pref., Japan|Masaki Clinic, Osaka city, Osaka pref., Japan|Nanko Clinic, Osaka city, Osaka pref., Japan|Osaka Ekisaikai Hospital, Osaka city, Osaka pref., Japan|Tamatani Clinic, Osaka city, Osaka pref., Japan|Hayashi Clinic, Sakai city, Osaka pref., Japan|Nakao Medical Clinic, Sakai city, Osaka pref., Japan|Saga Memorial Clinic, Saga city, Saga pref., Japan|Enomoto Clinic, Ageo city, Saitama pref., Japan|Asano Internal Medicine Clinic, Kawagoe city, Saitama pref., Japan|Iryohojin Hogi Sinryojyo, Kawaguchi city, Saitama pref., Japan|Tokutake Iin, Kawaguchi city, Saitama pref., Japan|Medical Corporation Shibuya Clinic, Kumagaya city, Saitama pref., Japan|Tanaka Medical Clinic, Saitama city, Saitama pref., Japan|Yoshimura Eye&Internal Medical Clinic, Mishima city, Shizuoka pref., Japan|Shizuoka Municipal Hospital, Shizuoka city, Shizuoka pref., Japan|Takada Clinic, Tochigi city, Tochigi pref., Japan|Murakami Clinic, Anan city, Tokushima pref., Japan|Ota Clinic, Awa city, Tokushima pref., Japan|Arizumi Clinic, Itano gun, Tokushima pref., Japan|Yuki National Health Insurance Hospital of Minami Town, Kaifu gun, Tokushima pref., Japan|Sekishinkan Hospital, Komatsushima city, Tokushima pref., Japan|Iryohojin Tokujikai Tanaka Iin, Myozai gun, Tokushima pref., Japan|Kensei Uchimachi Clinic, Tokushima city, Tokushima pref., Japan|Yata Clinic, Yoshinogawa city, Tokushima pref., Japan|Tokyo Center Clinic, Chuo ku, Tokyo, Japan|Okudo Poly Clinic, Katsushika ku, Tokyo, Japan|Nakano Sunbright Clinic, Nakano ku, Tokyo, Japan|Sugawara Clinic, Nerima ku, Tokyo, Japan|Tsurumachi Clinic, Setagaya ku, Tokyo, Japan|Oda Clinic, Shinjuku ku, Tokyo, Japan|Ishii Clinic, Tachikawa city, Tokyo, Japan|Ayame Medical Clinic, Shimonoseki city, Yamaguchi pref., Japan|Matsuda Medical Clinic, Shimonoseki city, Yamaguchi pref., Japan|Mizumachi Medical Clinic, Shimonoseki city, Yamaguchi pref., Japan|Kuroda Iin, Otsuki city, Yamanashi pref., Japan|Yasue Naika, Gifu city, Japan
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