Patients with type 2 diabetes (T2D) often require multiple therapies to achieve glycaemic control. There has been no study evaluating alogliptin (ALO) when added to Metformin (MET) and a sulfonylurea (SU). We performed a post hoc analysis of the EXAMINE trial to evaluate the anti-hyperglycaemic effi cacy and safety of the addition of ALO to T2D patients on existing MET and SU in this study. A substantial population in EXAMINE entered on dual therapy with MET and SU (N=1,398; ALO=693, placebo (PBO) =705) and were followed for up to 40 months (median 18 months). Investigators were allowed to change therapies according to local standard of care including the existing dose of MET and SU. The type/dose of MET and of SU were neither standardised nor controlled. In this subgroup 550 ALO and 505 PBO patients persisted to study end without addition of other anti-hyperglycaemic therapy. For all patients on MET+SU at
baseline characteristics were similar for ALO and PBO groups (mean HbA1c, 8.14%). Changes from baseline for HbA1c observed in these subgroup analyses were as follows: (1) all patients randomised on baseline MET+SU: -0.38% ALO vs. +0.14% PBO, LS mean difference for change from baseline of HbA1c at last visit -0.52% (p<0.001); (2) patients persisting on MET+SU without addition of other glycaemic therapies: -0.43% ALO vs. +0.15%, LS mean difference -0.56% (p<0.001), and for the overall EXAMINE study population (−0.33% ALO vs. 0.03% PBO, LS mean difference -0.36% p < 0.001). The ALO and PBO groups did not differ in the percentage of patients with > 1 adverse event (AE) (75.2% ALO and 79.6% PBO) or serious AEs (28.3% ALO and 32.1% PBO). There was no signifi cant difference in the incidence of any report of hypoglycaemia (8.8% ALO and 6.7% PBO, p=0.161) or serious hypoglycaemia (1.30% ALO and 0.43% PBO, p=0.088). These data demonstrate that triple therapy with MET, SU and ALO in this double blind trial was effective and well tolerated. achieve glycaemic control. There has been no study evaluating alogliptin (ALO) when added to Metformin (MET) and a sulfonylurea (SU). We performed a post hoc analysis of the EXAMINE trial to evaluate the anti-hyperglycaemic efficacy and safety of the addition of ALO to T2D patients on existing MET and SU in this study. A substantial population in EXAMINE entered on dual therapy with MET and SU (N=1,398; ALO=693, placebo (PBO) =705) and were followed for up to 40 months (median 18 months). Investigators were allowed to change therapies according to local standard of care including the existing dose of MET and SU. The type/dose of MET and of SU were neither standardised nor controlled. In this subgroup 550 ALO and 505 PBO patients persisted to study end without
addition of other anti-hyperglycaemic therapy. For all patients on MET+SU at baseline characteristics were similar for ALO and PBO groups (mean HbA1c, 8.14%). Changes from baseline for HbA1c observed in these subgroup analyses
were as follows: (1) all patients randomised on baseline MET+SU: -0.38% ALO vs. +0.14% PBO, LS mean difference for change from baseline of HbA1c at last visit -0.52% (p<0.001); (2) patients persisting on MET+SU without addition of other glycaemic therapies: -0.43% ALO vs. +0.15%, LS mean difference -0.56% (p<0.001), and for the overall EXAMINE study population (−0.33% ALO vs. 0.03% PBO, LS mean difference -0.36% p < 0.001). The ALO and PBO groups did not differ in the percentage of patients with > 1 adverse event (AE) (75.2% ALO and 79.6% PBO) or serious AEs (28.3% ALO and 32.1% PBO). There was no signifi cant difference in the incidence of any report of hypoglycaemia (8.8% ALO and 6.7% PBO, p=0.161) or serious hypoglycaemia (1.30% ALO and 0.43% PBO, p=0.088). These data demonstrate that triple therapy with MET, SU and ALO in this double blind trial was effective and well tolerated.