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薬理と治療
- Author: 加来浩平1
Abstract
Objective To assess the efficacy and safety of long-term monotherapy with anagliptin administered before or after meals in Japanese patients with type 2 diabetes. Methods This was a multi-centre, 52-week, randomized, open-label, parallel-group study. Patients were randomized(1:1)to receive anagliptin(100 mg twice daily before meals, n=81)or anagliptin(100 mg twice daily after meals, n=70). After 16 weeks, patients who did not achieve the HbA1c goal(less than 6.9%)received the increased dose of anagliptin(200mg twice daily). The primary endpoint was the change from baseline in HbA1c at 12 weeks. Results Mean baseline age and HbA1c were 57.9 years and 8.2%, respectively. Baseline characteristics were similar in the two groups. After 12 weeks of treatment with anagliptin, mean changes from baseline in HbA1c were -0.63%(95%CI:-0.78, -0.48)when administered before meals versus -0.56%(95%CI:-0.69, -0.43)when administered after meals. Significant reductions from baseline in HbA1c were sustained through 52 weeks regardless of administration before or after meals. Anagliptin was generally well tolerated. Hypoglycaemic events were rare, and a drug-related hypoglycaemic event occurred in only one patient(0.7%). Conclusions Long-term monotherapy with anagliptin administered before or after meals significantly improved glycaemic control and was well tolerated in Japanese patients with type 2 diabetes.
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