DPP-4 Inhibitor with Biguanide (Fixed-Dose Combination) Pregnancy: Should not be used during pregnancy — no human data with the combination; studies in pregnant rats with alogliptin plus metformin have shown reproductive toxicity. Breast-feeding: both substances are excreted in the milk of lactating rats and metformin is excreted in human milk in small amounts; a risk to the suckling child cannot be excluded — decide whether to discontinue breast-feeding or the medicine.

Alogliptin with Metformin

Brand names: Vipdomet

A fixed-dose oral combination of the DPP-4 inhibitor alogliptin with metformin, used in type 2 diabetes when a single oral agent gives inadequate glycaemic control. This page covers the combination tablet and the cautions of both components.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: One tablet of 12.5 mg/850 mg or 12.5 mg/1000 mg twice daily — corresponding to 25 mg alogliptin plus 1700 mg or 2000 mg metformin hydrochloride daily, depending on the dose of metformin already being taken (for patients inadequately controlled on the maximal tolerated dose of metformin alone)

Route: Oral — take with meals to reduce the gastrointestinal adverse reactions associated with metformin; swallow tablets whole with water

Frequency: Twice daily (required because of the pharmacokinetics of the metformin component)

Max: The maximum recommended daily dose of 25 mg alogliptin should not be exceeded (metformin maximum daily dose depends on GFR — see renal adjustment)

Adults aged 18 years and over with normal renal function (GFR 90 mL/min or above). Dose should be individualised on the basis of the patient's current treatment regimen. Inadequately controlled on metformin plus pioglitazone: maintain the pioglitazone dose and give alogliptin 12.5 mg twice daily (25 mg total daily) with metformin at a similar dose to that already taken (850 mg or 1000 mg twice daily). Switching from separate alogliptin and metformin tablets (dual therapy or as part of triple therapy with insulin): dose both at the total daily dose already being taken — the individual alogliptin dose is halved as it is now taken twice daily, while metformin dosing remains unchanged. Inadequately controlled on insulin plus maximal tolerated metformin: provide alogliptin 12.5 mg twice daily plus a metformin dose similar to that already taken; a lower insulin dose may be considered to reduce hypoglycaemia risk. Caution with a thiazolidinedione (triple therapy) — increased risk of hypoglycaemia; consider a lower thiazolidinedione or metformin dose. Elderly: no adjustment based on age, but dose alogliptin conservatively in advanced age. Hepatic impairment: must not be used. Paediatric: safety and efficacy in under-18s not established; no data available. Missed dose: skip it and take the next dose as scheduled — do not double the dose. Discontinue before or at the time of intravascular iodinated contrast imaging and do not restart until at least 48 hours afterwards, provided renal function has been re-evaluated and is stable. Note: SPC section 4.5 (interactions) was not captured in the fetched bundle.

Dose adjustments

Renal

Assess GFR before initiation and at least annually (every 3-6 months if at increased risk of progression or elderly). GFR 60-89 mL/min: metformin maximum 3000 mg daily (dose reduction may be considered as renal function declines), alogliptin maximum 25 mg daily. GFR 45-59: metformin maximum 2000 mg daily with a starting dose at most half the maximum, alogliptin maximum 12.5 mg daily. GFR 30-44: metformin maximum 1000 mg daily with a starting dose at most half the maximum, alogliptin maximum 12.5 mg daily. GFR below 30: metformin is contraindicated, alogliptin maximum 6.25 mg daily. The maximum daily metformin dose should preferably be divided into 2-3 daily doses. If no adequate strength of the fixed-dose combination is available, use the individual monocomponents instead.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substances or to any of the excipients, or history of a serious hypersensitivity reaction (including anaphylactic reaction, anaphylactic shock and angioedema) to any DPP-4 inhibitor
Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)
Diabetic pre-coma
Severe renal failure (GFR below 30 mL/min)
Acute conditions with the potential to alter renal function, such as dehydration, severe infection or shock
Acute or chronic disease which may cause tissue hypoxia, such as cardiac or respiratory failure, recent myocardial infarction or shock
Hepatic impairment
Acute alcohol intoxication, alcoholism

Side effects

Abdominal pain and diarrhoea (very common with metformin; common with the combination)
Nausea, vomiting and loss of appetite (very common with metformin), gastritis, gastro-oesophageal reflux disease, gastroenteritis (common)
Headache and metallic taste (common)
Upper respiratory tract infections and nasopharyngitis (common)
Hypoglycaemia, pruritus and rash (common); vitamin B12 decrease/deficiency (common, metformin component)
Lactic acidosis (very rare, metformin component) and acute pancreatitis / serious hypersensitivity reactions including Stevens-Johnson syndrome, anaphylaxis and angioedema (alogliptin component) — serious adverse reactions

Interactions

Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and NSAIDs) should be initiated with caution in metformin-treated patients — risk of metformin accumulation and lactic acidosis (§4.4)
Intravascular iodinated contrast media — may cause contrast-induced nephropathy with metformin accumulation and increased risk of lactic acidosis; discontinue before or at the time of imaging and restart no sooner than 48 hours after, once renal function is confirmed stable (§4.4)
Alcohol — acute alcohol intoxication and alcoholism are contraindicated; excessive alcohol intake is a risk factor for lactic acidosis (§4.3, §4.4)
Sulphonylureas, insulin or a thiazolidinedione plus metformin — increased risk of hypoglycaemia; a lower dose of insulin or of the thiazolidinedione/metformin may be considered (§4.2, §4.4)
Other medicinal products that may cause lactic acidosis — concomitant use is a risk factor (§4.3, §4.4)

Clinical monograph

How it works

Alogliptin inhibits dipeptidyl peptidase-4 to prolong incretin activity and enhance glucose-dependent insulin secretion, while metformin reduces hepatic glucose production and improves peripheral insulin sensitivity.

Prescribing in practice

Lactic acidosis from the metformin component is the key safety concern — withhold during acute kidney injury, dehydration, sepsis or before iodinated contrast, and avoid below the renal threshold for metformin.
Alogliptin has been associated with acute pancreatitis and, rarely, severe hypersensitivity reactions, so stop if these are suspected.
Hypoglycaemia is uncommon with this pairing alone but rises when combined with sulfonylureas or insulin, which may need dose reduction.

Monitoring

Monitor renal function, glycaemic control (HbA1c) and for symptoms of pancreatitis or hypersensitivity during treatment.

Counselling the patient

Take with or after food to reduce stomach upset.
Stop and seek advice if you become acutely unwell, dehydrated or have persistent severe abdominal pain.
Remind any clinician arranging a scan with contrast dye that you take metformin.

Evidence & guidelines

Both components have established glucose-lowering efficacy in randomised trials, and the fixed-dose combination simplifies dual therapy in type 2 diabetes.

Reference: NICE NG28 (Type 2 diabetes in adults, 2022); EXAMINE trial (NEJM 2013); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways