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- 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.
- 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.
- 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.
- Subjects
TYPE 2 diabetes; SITAGLIPTIN; CLINICAL trials; METFORMIN; GLYCOSYLATED hemoglobin; CONFIDENCE intervals
- Publication
Diabetes, Obesity & Metabolism, 2015, Vol 17, Issue 5, p511
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/dom.12429