Another study of alogliptin as add-on to metformin was conducted in a cohort of Japanese patients with T2DM.
66 In a study of alogliptin in combination with metformin in 201 patients, Nauck et al found that the majority of AEs were unrelated to the study drug.
67 In a study of alogliptin added to pioglitazone, the AE rates among 372 patients completing the study were: 64.9% with placebo, 69.7% with alogliptin 12.5 mg and 72.4% with alogliptin 25 mg.
In agreement with a previous meta-analysis, that was conducted on DPP-4 inhibitors including four studies on alogliptin [ 27], this meta-analysis has demonstrated a significant reduction of HbA1c and FPG in patients treated with either alogliptin 12.5 mg or alogliptin 25 mg.
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).
Meta-analysis of phase II and III studies with alogliptin versus placebo calculated a relative risk of 0.63 (95% CI, 0.21-1.91) [ 36].
Six of the studies compared the effectiveness of alogliptin as add-on to other antidiabetic drug(s) against antidiabetic drug with placebo or without placebo [ 18- 23, 24, 26, 26] and the remaining four compared alogliptin alone with placebo [ 13, 21, 22, 25].
Covington et al studied single increasing doses of alogliptin in 36 subjects.
Another DPP-4 inhibitor study compared the addition of alogliptin (12.5 or 25 mg) or placebo once daily to a basal insulin plus metformin treatment regimen in 390 patients with mean A1C 9.3% (17).
This is because; two of the studies in the alogliptin monotherapy subgroup recruited patients with type 2 diabetes who were naïve to antidiabetic drugs [ 22, 25].
Accordingly, two studies with alogliptin used as monotherapy in drug-naïve patients are briefly described here.
