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薬理と治療
- Author: 加来浩平1
Abstract
Background and Aim Anagliptin, a novel dipeptidyl peptidase-4 inhibitor, has been investigated about its pharmacokinetic profile, efficacy and safety in phaseⅠ and Ⅱ trials. In this study, we investigated the efficacy and safety of anagliptin in a multi-centre, randomized, placebo- and active comparator-controlled, double-blind, parallel-group study in Japanese patients with type 2 diabetes mellitus. Methods A total of 244 subjects with type 2 diabetes were treated with 100 or 200 mg of anagliptin twice a day, 0.2 mg of voglibose three times a day or a placebo for 12 weeks. The markers for glycemic control were measured and investigated, and the change in HbA1c levels from baseline to week 12 was assessed as the primary endpoint of this study. Results HbA1c values in anagliptin-treated groups were decreased much more significantly compared to those in both placebo-treated and voglibose-treated groups. The fasting plasma glucose, 2-h postprandial glucose, area under the curve(AUC)0-2h of glucose, 1,5-AG, glycoalbumin and proinsulin/insulin ratio in anagliptin-treated groups were also more significantly improved compared to those in the placebo-treated group. The ΔAUC0-2h of plasma glucagon in anagliptin-treated groups significantly decreased, but not in the placebotreated group. We did not observe any clinically important adverse events. Conclusions The present results demonstrated the efficacy and safety of anagliptin in the patients with type 2 diabetes mellitus. Additionally, anagliptin decreased the HbA1c level more greatly than voglibose. These results suggest that anagliptin would be a favorable drug for the therapy of type 2 diabetes.
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