Adults (≥18 years): The recommended dose is 25 mg alogliptin once daily as add‑on therapy to metformin, a thiazolidinedione, a sulphonylurea, or insulin, or as triple therapy with metformin and a thiazolidinedione or insulin. The medication is taken orally once daily, with or without food; tablets should be swallowed whole with water. Renal impairment: For mild renal impairment (CrCl >50 to ≤80 mL/min), no dose adjustment is needed. For moderate renal impairment (CrCl ≥30 to ≤50 mL/min), the dose should be reduced to 12.5 mg once daily. For severe renal impairment (CrCl <30 mL/min) or end‑stage renal disease requiring dialysis, the dose should be reduced to 6.25 mg once daily; dosing is independent of dialysis timing. Hepatic impairment: No dose adjustment is required in mild to moderate hepatic impairment (Child‑Pugh 5–9). Use is not recommended in severe hepatic impairment (Child‑Pugh >9). Elderly (≥65 years): No dose adjustment based on age, but dosing should be conservative due to potential decreased renal function. Paediatric population (<18 years): Safety and efficacy have not been established and alogliptin should not be used because of lack of efficacy; no posology recommendation can be made. Missed dose: If a dose is missed it should be taken as soon as remembered; a double dose should not be taken on the same day.

No dose adjustment is needed in mild renal impairment or mild to moderate hepatic impairment. Reduce to 12.5 mg once daily in moderate renal impairment and to 6.25 mg once daily in severe renal impairment or end-stage renal disease requiring dialysis; dosing is independent of dialysis timing. No adjustment is required based on age, although dosing should be conservative in older adults because of potential reduced renal function; use is not recommended in severe hepatic impairment, and no paediatric posology can be recommended because of lack of efficacy.

Across 13 studies involving 9,405 patients with type 2 diabetes mellitus, overall incidences of adverse events, serious adverse events, and discontinuations were comparable between alogliptin (25 mg and 12.5 mg), active control, and placebo; the most common adverse reaction with 25 mg alogliptin was headache. No adverse reactions were classified as very common (≥1/10). Common adverse reactions (≥1/100 to <1/10) included upper respiratory tract infections, nasopharyngitis, hypoglycaemia, headache, abdominal pain, gastroesophageal reflux disease, diarrhoea, pruritus, and rash. Important serious or clinically significant adverse reactions (frequency not known) included acute pancreatitis, hepatic dysfunction including hepatic failure, hypersensitivity reactions (including anaphylactic reactions and angioedema), exfoliative skin conditions such as Stevens‑Johnson syndrome and erythema multiforme, urticaria, bullous pemphigoid, and interstitial nephritis. Pooled analyses showed overall hypoglycaemia rates were low and similar or lower with alogliptin 25 mg compared to active control or placebo, with severe hypoglycaemia rare (0.1%).

Alogliptin is contraindicated in patients with hypersensitivity to alogliptin or any excipient, or in those with a history of serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, or angioedema, to any DPP‑4 inhibitor.

Safety and efficacy were evaluated in multiple phase 2 and phase 3 double-blind, placebo- or active-controlled clinical studies in adults with type 2 diabetes mellitus, including specific studies in patients with renal impairment, elderly patients, and a large cardiovascular outcomes trial in high cardiovascular-risk patients with recent acute coronary syndrome, as well as a paediatric trial in adolescents. Major studies included: - Pooled phase 2/3 glycaemic control programme: 14,779 adults with type 2 diabetes mellitus (6,448 on alogliptin 25 mg, 2,476 on 12.5 mg); mean age and sex distribution not reported. - Cardiovascular outcomes study: 5,380 adults with type 2 diabetes mellitus and high cardiovascular risk after a recent (15–90 days) acute coronary event (n=2,701 alogliptin, 2,679 placebo); mean age 61 years; percentage of women not reported. - Severe renal impairment/end-stage renal disease study: 115 adults with type 2 diabetes mellitus (59 alogliptin, 56 placebo) for 6 months; further demographics not reported. - Paediatric study: 151 patients aged 10–17 years with type 2 diabetes mellitus and insufficient glycaemic control; mean age and sex distribution not reported.