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

Jang Won Son, In Kyu Lee, Jeong Taek Woo, Sei-Hyun Baik, Hak Chul Jang, Kwan Woo Lee, Bong Soo Cha, Yeon Ah Sung, Tae Sun Park, Soon Jib Yoo, Kun Ho Yoon

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3 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)1049-1057
Number of pages9
JournalEndocrine Journal
Volume62
Issue number12
DOIs
Publication statusPublished - 2015 Dec 27

Keywords

  • Diabetes mellitus
  • Mitiglinide
  • Type 2
  • Voglibose

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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    Son, J. W., Lee, I. K., Woo, J. T., Baik, S-H., Jang, H. C., Lee, K. W., Cha, B. S., Sung, Y. A., Park, T. S., Yoo, S. J., & Yoon, K. H. (2015). 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, 62(12), 1049-1057. https://doi.org/10.1507/endocrj.EJ15-0325