Among patients with type 2 diabetes who had had a recent acute coronary syndrome, the rates of major adverse cardiovascular events were not increased with the DPP-4 inhibitor alogliptin as compared with placebo. (Funded by Takeda Development Center Americas; EXAMINE ClinicalTrials.gov number, NCT00968708.).

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Adding alogliptin to previous insulin therapy (with or without metformin) significantly improved glycaemic control in patients with type 2 diabetes inadequately controlled on insulin, without causing weight gain or increasing the incidence of hypoglycaemia. Further studies are warranted to explore the role of alogliptin added to optimized basal insulin regimens.

Summary Aims:  To evaluate the efficacy and safety of alogliptin, a new dipeptidyl peptidase‐4 inhibitor, for 26 weeks at once‐daily doses of 12.5 and 25 mg in combination with metformin in patients whose HbA1c levels were inadequately controlled on metformin alone. Methods and patients:  Patients with type 2 diabetes and inadequate glycaemic control (HbA1c 7.0‐10.0%) were randomised to continue a stable daily metformin dose regimen (≥ 1500 mg) plus the addition of placebo (n = 104) or alogliptin at once‐daily doses of 12.5 (n = 213) or 25 mg (n = 210). HbA1c, insulin, proinsulin, C‐peptide and fasting plasma glucose (FPG) concentrations were determined over a period of 26 weeks. Results:  Alogliptin at either dose produced least squares mean (SE) decreases from baseline in HbA1c of −0.6 (0.1)% and in FPG of −17.0 (2.5) mg/dl [−1.0 (0.1) mmol/l], decreases that were significantly (p < 0.001) greater than those observed with placebo. The between treatment differences (alogliptin – placebo) in FPG reached statistical significance (p < 0.001) as early as week 1 and persisted for the duration of the study. Overall, adverse events (AEs) observed with alogliptin were not substantially different from those observed with placebo. This includes low event rates for gastrointestinal side effects and hypoglycaemic episodes. There was no dose‐related pattern of AE reporting between alogliptin groups and few serious AEs were reported. Conclusion:  Alogliptin is an effective and safe treatment for type 2 diabetes when added to metformin for patients not sufficiently controlled on metformin monotherapy.

OBJECTIVE -To evaluate the dipeptidyl peptidase-4 (DPP-4) inhibitor alogliptin in drugnaïve patients with inadequately controlled type 2 diabetes. RESEARCH DESIGN AND METHODS-This double-blind, placebo-controlled, multicenter study included 329 patients with poorly controlled diabetes randomized to once-daily treatment with 12.5 mg alogliptin (n ϭ 133), 25 mg alogliptin (n ϭ 131), or placebo (n ϭ 65) for 26 weeks. Primary efficacy end point was mean change from baseline in A1C at the final visit.RESULTS -At week 26, mean change in A1C was significantly greater (P Ͻ 0.001) for 12.5 mg (Ϫ0.56%) and 25 mg (Ϫ0.59%) alogliptin than placebo (Ϫ0.02%). Reductions in fasting plasma glucose were also greater (P Ͻ 0.001) in alogliptin-treated patients than in those receiving placebo. Overall, incidences of adverse events (67.4 -70.3%) and hypoglycemia (1.5-3.0%) were similar across treatment groups.CONCLUSIONS -Alogliptin monotherapy was well tolerated and significantly improved glycemic control in patients with type 2 diabetes, without raising the incidence of hypoglycemia.

In patients with type 2 diabetes inadequately controlled by glyburide monotherapy, the addition of alogliptin resulted in clinically significant reductions in HbA1c without increased incidence of hypoglycaemia.

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OBJECTIVETo assess the efficacy and tolerability of alogliptin plus pioglitazone for initial combination therapy in drug-naïve type 2 diabetic patients.RESEARCH DESIGN AND METHODSThis 26-week, double-blind, parallel-group study randomized 655 patients with inadequately controlled type 2 diabetes to four arms: 25 mg alogliptin (A25) q.d. monotherapy, 30 mg pioglitazone (P30) q.d. monotherapy, or 12.5 (A12.5) or 25 mg alogliptin q.d. plus pioglitazone (P30) q.d. combination therapy. Primary efficacy was A1C change from baseline with the high-dose combination (A25 + P30) versus each monotherapy.RESULTSCombination therapy with A25 + P30 resulted in greater reductions in A1C (−1.7 ± 0.1% from an 8.8% mean baseline) vs. A25 (−1.0 ± 0.1%, P < 0.001) or P30 (−1.2 ± 0.1%, P < 0.001) and in fasting plasma glucose (−2.8 ± 0.2 mmol/l) vs. A25 (−1.4 ± 0.2 mmol/l, P < 0.001) or P30 (−2.1 ± 0.2 mmol/l, P = 0.006). The A25 + P30 safety profile was consistent with those of its component monotherapies.CONCLUSIONSAlogliptin plus pioglitazone combination treatment appears to be an efficacious initial therapeutic option for type 2 diabetes.