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18 Because treatment with anagliptin exhibits dose-dependent improvements in the HbA1c and blood glucose levels according to the results of a Phase II trial including a dose-ranging study (50�C400 mg daily),19 increases in the dose up to 400 mg daily (200 mg, BID) have been approved.18 In one study, the reduction in the HbA1c values from baseline after 12 weeks monotherapy with 200 mg (n=69) and 400 mg (n=68) of daily anagliptin was 0.75%��0.50% E-64 and 0.82%��0.46%, respectively, and more than 40% of the subjects receiving anagliptin at a dose of 200 mg or 400 mg daily achieved an HbA1c level below 6.9%.19 In another Phase II/III trial, the administration of monotherapy for 12 weeks demonstrated a reduction of 0.66%��0.50% and 0.75%��0.55% in the HbA1c levels with 200 mg (n=63) and 400 mg (n=58) of daily anagliptin, respectively.20 The differences in the HbA1c levels versus the placebo group among the subjects receiving 200 mg and 400 mg of anagliptin daily were ?0.72% and ?0.82%, respectively.20 According to a pooled analysis of the data obtained from Phase II and Phase II/III trials, the goal achievement rate of an HbA1c level less than 7.0% was 51.1% in the group treated with anagliptin at a dose of 200 mg (100 mg, BID) at 12 weeks, which was significantly superior to that attained with voglibose, an ��-glucosidase inhibitor.21 Long-term efficacy of monotherapy Kaku17 reported that the use of monotherapy with anagliptin at a daily dose of 200 mg (with dose increases up to R428 400 mg permitted if the glucose-lowering effect was insufficient) showed continuous improvements in the HbA1c levels over 52 weeks in 150 patients with type 2 diabetes whose blood glucose levels were poorly controlled (6.9%�� HbA1csee more after receiving nonpharmacological therapy. The changes in the HbA1c, fasting blood glucose, and postprandial 2-h blood glucose levels were ?0.63%��0.85% (baseline value: 8.22%��1.06%), ?12.5��32.2 mg/dL (baseline value: 166.1��38.4 mg/dL), and ?31.0��47.8 mg/dL (baseline value: 255.1��60.3 mg/dL), respectively. Furthermore, improvements were noted in the levels of 1,5-AG, glycoalbumin, serum insulin, proinsulin, homeostatic model assessment-��, total cholesterol, and low-density lipoprotein (LDL)�Ccholesterol. Combination therapy The changes in the HbA1c levels observed in a Phase III trial22 of anagliptin as an add-on therapy to ��-glucosidase inhibitors (acarbose 20.2%, voglibose 43.6%, and miglitol 36.2%), biguanides (metformin), sulfonylureas (glimepiride 73.5%, gliclazide 10.3%, and glibenclamide 16.2%), and thiazolidinediones (pioglitazone) are shown in Table 2. In this trial, treatment with anagliptin at a dose of 200 mg daily (100 mg, BID) or a placebo was administered for an initial 12 weeks in patients with type 2 diabetes whose HbA1c levels were between 6.9% and 10.4%, even after treatment with other OADs. Anagliptin was subsequently administered at a dose of 200 mg daily for 40 weeks in both groups.