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

Endocrine Journal

Ki-Ho Song⁷  Kun-Ho Yoon⁸  Soon Jib Yoo⁵  Hae Kyung Yang⁸  Ie Byung Park^1,15  Sei Hyun Baik^1,16  Jeong Hyun Park⁶  Kyong Soo Park^1,19  Kyung Wan Min^1,17  Choon Hee Chung¹  Sung Hee Choi^1,18  Sung Woo Park⁴  Jaetaek Kim^1,10  Bong-Soo Cha⁹  In-Kyu Lee^1,13  Tae Sun Park³  Yeon-Ah Sung^1,14  Doo-Man Kim^1,11  Moon-Kyu Lee^1,12  Yu Bae Ahn²  In Joo Kim^2,20 

[1] Department of Internal Medicine, Yonsei University, Wonju College of Medicine, Wonju, 220-701, Korea;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;Division of Endocrinology and Metabolism, Department of Internal Medicine, Research Institute of Clinical Medicine, Chonbuk National University Medical School, Jeonju, 561-712, Korea;Diabetes Research Institute, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, 110-746, Korea;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;Department of Internal Medicine, Busan Paik Hospital, College of Medicine, Paik Institute for Clinical Research, Inje University, Busan, 614-735, Korea;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;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;Department of Internal Medicine, Yonsei University College of Medicine, Seoul, 120-749, Korea;Division of Endocrinology and Metabolism, Department of Internal Medicine, Chung-Ang University, Seoul, 156-755, Korea;Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, Seoul, 134-701, Korea;Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 135-710, Korea;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;Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, 120-750, South Korea;Division of Endocrinology and Metabolism, Gachon University, Gil Medical Center, Incheon, 405-760, Korea;Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, Korea University, Seoul, 136-701, Korea;Diabetes Center, Eulji General Hospital, Eulji University School of Medicine, Seoul, 139-872, Korea;Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, 463-707, Korea;Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, 110-744, Korea;Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine, Busan, 602-739, Korea

关键词: DPP-4 inhibitor;    Glycemic control;    Type 2 diabetes;   

DOI  :  10.1507/endocrj.EJ14-0544

学科分类：内分泌与代谢学

来源: Japan Endocrine Society

【 摘 要 】

References(23)Cited-By(3)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.

【 授权许可】

Unknown