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薬理と治療
Abstract
Background Anagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin hydrochloride, a biguanide, are both effective and widely used drugs for the treatment of type 2 diabetes mellitus. We investigated the efficacy and safety of combination therapies of anagliptin and metformin hydrochloride in the studies with anagliptin as an add-on to metformin hydrochloride(AM1001)and with metformin hydrochloride as an add-on to anagliptin (AM1002). Methods In the study AM1001, a total of 209 subjects with inadequately controlled type 2 diabetes mellitus receiving metformin hydrochloride at doses of 250 or 500 mg twice per day were treated with 100 mg anagliptin or placebo twice per day for 24 weeks. Thereafter, all subjects receiving metformin hydrochloride at a dose of 500 mg twice per day were continued on anagliptin 100 mg twice per day in an open-label extension for 28 weeks. In the study AM1002, a total of 158 subjects with inadequately controlled type 2 diabetes mellitus receiving anagliptin at a dose of 100 mg twice per day were treated with 250 or 500 mg of metformin hydrochloride or placebo twice per day for 24 weeks. The primary endpoint for each study was the change in HbA1c from baseline to the end of the 24-week treatment period. Results After 24 weeks, in the AM1001 study, the HbA1c levels in the anagliptin add-on groups significantly decreased compared to those in the placebo add-on groups. A significant reduction in HbA1c level from the baseline was sustained throughout 52 weeks. After 24 weeks, in the AM1002 study, the HbA1c levels in the metformin hydrochloride add-on groups significantly decreased compared to that in the placebo add-on group. The incidence of adverse events was comparable between the groups treated with the combination therapy of anagliptin and metformin hydrochloride and each administered as a monotherapy. Conclusions We demonstrated that the combination therapy with anagliptin and metformin hydrochloride was effective for the improvement of glycemic control and well tolerated in inadequately controlled type 2 diabetes patients receiving each as a monotherapy. These results suggest that the combination therapy with anagliptin and metformin hydrochloride was effective in treating type 2 diabetes mellitus.
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