A prospective, randomized, multicenter trial comparing the efficacy and safety of the concurrent use of long-acting insulin with mitiglinide or voglibose in patients with type 2 diabetes

Endocrine Journal

Kun-Ho Yoon⁴  Kwan Woo Lee⁹  Sei Hyun Baik⁷  Jeong-taek Woo^1,10  In-Kyu Lee⁶  Tae Sun Park⁵  Bong Soo Cha⁸  Jang-Won Son²  Hak Chul Jang¹  Yeon-Ah Sung³  Soon-Jib Yoo² 

[1] Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea;Department of Internal Medicine, College of Medicine, Bucheon St. Mary’s Hospital, The Catholic University of Korea, Bucheon, Korea;Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea;Department of Internal Medicine, College of Medicine, Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul, Korea;Department of Internal Medicine, Chonbuk National University Hospital, Jeonju, Korea;Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea;Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea;Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea;Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea;Department of Endocrinology and Metabolism, Research Institute of Endocrinology, School of Medicine, Kyung Hee University, Seoul, Korea

关键词: Diabetes mellitus;    Type 2;    Mitiglinide;    Voglibose;   

DOI  :  10.1507/endocrj.EJ15-0325

学科分类：内分泌与代谢学

来源: Japan Endocrine Society

【 摘 要 】

References(27)This trial was conducted to compare the efficacy and safety of combination therapy with basal insulin glargine plus mitiglinide to that of basal insulin glargine plus voglibosein patients with type 2 diabetes.This was a 20-week, randomized, multicenter non-inferiority trial.Patients with HbA1c levels over 7.0% were randomly assigned to receive either mitiglinide (10 mg tid) or voglibose (0.2 mg tid) concurrent with insulin glargine for 16 weeks after a 4-week of basal insulin glargine monotherapy.The intention-to-treat population included 156 patients; 79 were placed in the mitiglinide group, and 77 were placed in the voglibose group.At 20 weeks, there was no significant difference between the mitiglinide group and the voglibose group in terms of the mean HbA1c level or the mean decrease of the HbAlc level from baseline (-0.9% [-7.5 mmol/mol] and -0.7%, [-5.3 mmol/mol] respectively).The mean fasting plasma glucose level and data of self-monitoring blood glucosewere significantly decreased from baseline to week 20 in both groups, but there was no significant difference between the two groups.The changes in the basal insulin requirements of each group were not significant.The prevalence of adverse events and the risk of hypoglycemia were similar for both groups.Combination therapy with mitiglinide plus basal insulin glargine was non-inferior to voglibose plus basal insulin glargine in terms of the effect on overall glycemic control.

【 授权许可】

Unknown