Anagliptin and sitagliptin as add-ons to metformin for patients with type 2 diabetes: A 24-week, multicentre, randomized, double-blind, active-controlled, phase III clinical trial with a 28-week extension

S. M. Jin, S. W. Park, K. H. Yoon, K. W. Min, K. H. Song, K. S. Park, J. Y. Park, I. B. Park, C. H. Chung, Sei-Hyun Baik, S. H. Choi, H. W. Lee, I. K. Lee, D. M. Kim, M. K. Lee

Research output: Contribution to journalLetter

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Abstract

We conducted a 24-week, multicentre, double-blind, randomized study with a 28-week extension to compare the efficacy and safety of anagliptin and sitagliptin as an add-on to metformin in patients with type 2 diabetes. Patients inadequately controlled on metformin were randomized to either anagliptin (100mg twice daily, n=92) or sitagliptin (100mg once daily, n=88). The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to week 24. The mean changes in HbA1c were -0.85±0.70% (p<0.0001) for anagliptin and -0.83±0.61% (p<0.0001) for sitagliptin, with a mean difference of -0.02% (95% confidence interval of difference, -0.22 to 0.18%). In both groups, the fasting proinsulin:insulin ratio significantly decreased from baseline, with improved insulin secretion. Safety profiles were similar in each group. In conclusion, the non-inferiority of the efficacy of anagliptin to sitagliptin as an add-on therapy was established with regard to efficacy and safety.

Original languageEnglish
Pages (from-to)511-515
Number of pages5
JournalDiabetes, Obesity and Metabolism
Volume17
Issue number5
DOIs
Publication statusPublished - 2015 May 1

Keywords

  • Antidiabetic drug
  • Diabetes care
  • DPP-IV inhibitor
  • Incretin therapy

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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    Jin, S. M., Park, S. W., Yoon, K. H., Min, K. W., Song, K. H., Park, K. S., Park, J. Y., Park, I. B., Chung, C. H., Baik, S-H., Choi, S. H., Lee, H. W., Lee, I. K., Kim, D. M., & Lee, M. K. (2015). Anagliptin and sitagliptin as add-ons to metformin for patients with type 2 diabetes: A 24-week, multicentre, randomized, double-blind, active-controlled, phase III clinical trial with a 28-week extension. Diabetes, Obesity and Metabolism, 17(5), 511-515. https://doi.org/10.1111/dom.12429