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

Title
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
Author(s)
이형우M.K. Lee[M.K. Lee]S.M. Jin [S.M. Jin ]K.H Yoon[K.H Yoon]K. W Min[K. W Min]I K Lee[I K Lee]D.M. Kim [D.M. Kim ]J.Y Park[J.Y Park]I. B. Park[I. B. Park]K.H. Song[K.H. Song]
Keywords
DIPEPTIDYL PEPTIDASE-4 INHIBITOR; EFFICACY; VILDAGLIPTIN; SAFETY
Issue Date
201505
Publisher
WILEY-BLACKWELL
Citation
DIABETES OBESITY & METABOLISM, v.17, no.5, pp.511 - 515
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 (100 mg twice daily, n = 92) or sitagliptin (100 mg 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.
URI
http://hdl.handle.net/YU.REPOSITORY/32456http://dx.doi.org/10.1111/dom.12429
ISSN
1462-8902
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의과대학 > 내과학교실 > Articles
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