A randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of anagliptin in drug-naïve patients with type 2 diabetes
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- Yang Hae Kyung
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, 137-701, Korea
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- Min Kyung Wan
- Diabetes Center, Eulji General Hospital, Eulji University School of Medicine, Seoul, 139-872, Korea
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- Park Sung Woo
- Diabetes Research Institute, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, 110-746, Korea
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- Chung Choon Hee
- Department of Internal Medicine, Yonsei University, Wonju College of Medicine, Wonju, 220-701, Korea
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- Park Kyong Soo
- Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, 110-744, Korea
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- Choi Sung Hee
- Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, 463-707, Korea
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- Song Ki-Ho
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeouido St.Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, 150-713, Korea
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- Kim Doo-Man
- Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, Seoul, 134-701, Korea
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- Lee Moon-Kyu
- Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 135-710, Korea
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- Sung Yeon-Ah
- Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, 120-750, South Korea
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- Baik Sei Hyun
- Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, Korea University, Seoul, 136-701, Korea
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- Kim In Joo
- Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine, Busan, 602-739, Korea
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- Cha Bong-Soo
- Department of Internal Medicine, Yonsei University College of Medicine, Seoul, 120-749, Korea
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- Park Jeong Hyun
- Department of Internal Medicine, Busan Paik Hospital, College of Medicine, Paik Institute for Clinical Research, Inje University, Busan, 614-735, Korea
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- Ahn Yu Bae
- Division of Endocrinology and Metabolism, Department of Internal Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Suwon, 442-723, Korea
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- Lee In-Kyu
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Research Institute of Aging and Metabolism, Kyungpook National University School of Medicine, Daegu, 700-721, Korea
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- Yoo Soon Jib
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Bucheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Bucheon, 420-717, Korea
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- Kim Jaetaek
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Chung-Ang University, Seoul, 156-755, Korea
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- Park Ie Byung
- Division of Endocrinology and Metabolism, Gachon University, Gil Medical Center, Incheon, 405-760, Korea
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- Park Tae Sun
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Research Institute of Clinical Medicine, Chonbuk National University Medical School, Jeonju, 561-712, Korea
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- Yoon Kun-Ho
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, 137-701, Korea
書誌事項
- タイトル別名
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- A randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of anagliptin in drug-naïve patients with type 2 diabetes
この論文をさがす
抄録
The aim of this study was to evaluate the efficacy and safety of anagliptin in drug-naïve patients with type 2 diabetes in a double-blind randomized placebo-controlled study. A total of 109 patients were randomized to 100 mg (n=37) or 200 mg (n=33) anagliptin twice daily or placebo (n=39). The primary objective was to alter HbA1c levels from baseline at a 24-week endpoint. The overall baseline mean age and body mass index were 56.20 ± 9.77 years and 25.01 ± 2.97 kg/m2, respectively, and the HbA1c level was of 7.14 ± 0.69 %. Anagliptin at 100 mg and 200 mg produced significant reductions in HbA1c (-0.50 ± 0.45 % and -0.51 ± 0.55%, respectively), and the placebo treatment resulted in an increase in HbA1c by 0.23 ± 0.62 %. Both doses of anagliptin produced significant decreases in fasting plasma glucose (-0.53 ± 1.25 mmol/L and -0.72 ± 1.25 mmol/L, respectively) and the proinsulin/insulin ratio (-0.04 ± 0.15 and -0.07 ± 0.18, respectively) compared with placebo. No meaningful body weight changes from baseline were observed in three groups. Plasma dipeptidyl peptidase (DPP)-4 activity was significantly inhibited after 24 weeks of anagliptin treatment, and >75% and >90% inhibitions were observed during the meal tolerance tests with 100 mg and 200 mg anagliptin, respectively. The incidences of adverse or serious adverse events were similar among the three study groups. Twice-daily anagliptin therapy effectively inhibited DPP-4 activity and improved glycemic control and was well-tolerated in patients with type 2 diabetes.
収録刊行物
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- Endocrine Journal
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Endocrine Journal 62 (5), 449-462, 2015
一般社団法人 日本内分泌学会