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41 Twice-daily dosing is recommended to achieve a total daily dose of 25 mg of alogliptin.
Asymptomatic hypoglycemia was reported in 5 subjects (1 on 50 mg, 2 on 200 mg, 1 on 400 mg of alogliptin and 1 on placebo).
More patients in the alogliptin group achieved HbA1c reductions of >0.5% (26.3% with placebo, 47.3% with 12.5 mg and 50.5% with 25 mg of alogliptin; P < 0.001).
83 Administration of 25 mg of alogliptin to 8 subjects with moderate hepatic impairment did not result in any serious AEs.
Twenty-five participants were randomized to receive 12.5 25.0 mg of alogliptin per day, with 26 participants randomized to receive treatment with a traditional Japanese diet.
Similarly more patients in the alogliptin arm had HbA1c reductions of >1% compared with placebo (13.1% with placebo, 18.7% with 12.5 mg and 29.8% with 25 mg of alogliptin; P < 0.001 for 25 mg and 0.149 for 12.5 mg).
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The effectiveness and tolerability of the two doses of alogliptin (12.5 mg and 25 mg) alone and as an added-on with other antidiabetic drug as compared to placebo or other antidiabetic drug were determined using the random effects model.
54, 55 Mean plasma DPP-4 inhibition after a single dose of alogliptin (25 mg to 800 mg) ranged from 74.3%to94%4% at 24 hours and 47.5% to 83% at 72 hours.
Furthermore, the effect of either dose of alogliptin (12.5 mg and 25 mg) on serum lev of total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides was not also significantly different from controls (Table 3).
However, the aim of this meta-analysis was to assess the efficacy and tolerability of alogliptin (25 mg and 12.5 mg), which is not yet approved in many countries as monotherapy and/or add-on therapy in patients with type 2 diabetes.
Participants were randomized to one of three study arms: addition of alogliptin 12.5 mg (n=213), alogliptin 25.0 mg (n=210), or placebo (n=104).
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