Alogliptin / Metformin

Vipdomet · ATC code A10BD13

Also known as: Alogliptin/Metformin

Key facts
Active substance
Alogliptin / Metformin
Drug class
Anti-diabetic medication
ATC code
A10BD13
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Vipdomet 12.5 mg/850 mg film-coated tablets / Vipdomet 12.5 mg/1 000 mg film-coated tablets
Marketing authorisation holder
Takeda Pharma A/S
Information as of
2026-10-28

Key facts

Alogliptin/metformin is a fixed-dose combination of a DPP-4 inhibitor and a biguanide. It is used in adults with type 2 diabetes to improve glycaemic control.

What it is used for

  • Adults aged 18 years and older with type 2 diabetes mellitus, as an adjunct to diet and exercise, when the maximal tolerated dose of metformin alone is insufficient or in patients already treated with alogliptin and metformin (Vipdomet).
  • In combination with pioglitazone or with insulin (triple therapy) when previous treatment is insufficient.

Dosing

  • Vipdomet is available as 12.5 mg/850 mg and 12.5 mg/1,000 mg film-coated tablets; the dose is based on the current regimen.
  • Inadequately controlled on metformin alone: one 12.5 mg/850 mg or 12.5 mg/1,000 mg tablet twice daily (25 mg alogliptin plus 1,700 mg or 2,000 mg metformin hydrochloride daily).
  • With pioglitazone or insulin: alogliptin 12.5 mg twice daily and metformin at a dose similar to that already taken; a lower insulin or thiazolidinedione dose may be considered.
  • The maximum daily dose of 25 mg alogliptin should not be exceeded.
  • Assess GFR before starting and at least annually. GFR 45-59 mL/min: metformin max 2,000 mg, alogliptin max 12.5 mg daily; GFR 30-44 mL/min: metformin max 1,000 mg, alogliptin max 12.5 mg daily; GFR < 30 mL/min: contraindicated. See the full text for details.
  • Hepatic impairment: must not be used.

Contraindications

  • Hypersensitivity to the active substances or excipients, or history of a serious hypersensitivity reaction to any DPP-4 inhibitor.
  • Any acute metabolic acidosis (e.g. lactic acidosis, diabetic ketoacidosis); diabetic pre-coma.
  • Severe renal failure (GFR < 30 mL/min) and acute conditions that may alter renal function (dehydration, severe infection, shock).
  • Diseases that may cause tissue hypoxia (e.g. cardiac or respiratory failure, recent myocardial infarction), hepatic impairment, acute alcohol intoxication, alcoholism.

Important warnings

  • Not for type 1 diabetes; not a substitute for insulin.
  • Lactic acidosis (very rare but serious): stop temporarily in dehydration; start medicines that can acutely impair renal function with caution.
  • Iodinated contrast agents: stop before or at the time of imaging and do not restart until at least 48 hours after, once renal function is stable.
  • Increased risk of hypoglycaemia with insulin or a thiazolidinedione.
  • Acute pancreatitis and hypersensitivity reactions are attributed to the alogliptin component. See the full text for further warnings.

Side effects

  • Serious: acute pancreatitis, hypersensitivity reactions (Stevens-Johnson syndrome, anaphylactic reactions, angioedema) and lactic acidosis (very rare, < 1/10,000).
  • Common: upper respiratory tract infections, nasopharyngitis, headache, gastroenteritis, abdominal pain, diarrhoea, vomiting, gastritis, reflux disease, pruritus, rash, hypoglycaemia.

Interactions

  • Alcohol increases the risk of lactic acidosis; concomitant use not recommended.
  • Iodinated contrast agents (see warnings).
  • Medicines that can acutely impair renal function (e.g. antihypertensives, diuretics, NSAIDs) should be started with caution.

Pregnancy and breastfeeding

  • Vipdomet should not be used during pregnancy; for breast-feeding see the full text.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • VipdometTakeda Pharma A/S · EMEA/H/C/002654

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Vipdomet
Liechtenstein
Vipdomet
Norway
Vipdomet

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Vipdomet – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/vipdomet-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC A10BD.

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.