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
- Authors
- 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.
- Issue Date
- May-2015
- Publisher
- WILEY-BLACKWELL
- Keywords
- antidiabetic drug; diabetes care; DPP-IV inhibitor; incretin therapy
- Citation
- DIABETES OBESITY & METABOLISM, v.17, no.5, pp.511 - 515
- Journal Title
- DIABETES OBESITY & METABOLISM
- Volume
- 17
- Number
- 5
- Start Page
- 511
- End Page
- 515
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/10557
- DOI
- 10.1111/dom.12429
- ISSN
- 1462-8902
- 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.
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