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Insulin degludec

AEMPS

Ultra-long-acting insulin analogue

ATC code: A10AE06

Brand names: Tresiba, Xultophy

Updated · Methodology

Indications

A

Insulin-dependent type 2 diabetes mellitus

First line

In type 2 diabetes degludec is used as the basal insulin, most often in people with nocturnal hypoglycaemia on other basal products or with an unstable daily schedule. In the DEVOTE trial (NEJM 2017) patients at high cardiovascular risk had fewer severe hypoglycaemic episodes on degludec than on glargine U100 at comparable glycaemic control. Metformin usually continues when basal insulin starts, while a sulfonylurea is revisited: the Tresiba label states that oral antidiabetic drugs potentiate the hypoglycaemic effect. A fixed combination with liraglutide exists, and there the warnings of both components apply.

Sources

  1. AEMPS: Ficha técnica Tresiba 100 unidades/ml FlexTouch solución inyectable (2026)
  2. redGDPS: Guía de diabetes tipo 2 para clínicos (2024)

ICD-10: E11.9 · ICD-11: 5A11

A

Type 1 diabetes mellitus

First line

Degludec covers the basal requirement in type 1 diabetes with a single injection, and its duration forgives a shifted injection time – the AEMPS Tresiba label allows the interval to move as long as at least 8 hours separate doses. That matters for teenagers and for people on shift work, where a fixed injection hour does not hold. The product is approved from 1 year of age. The dose reaches steady state in 2–3 days, so titration steps belong no more often than every 3–4 days; otherwise titration outruns accumulation and ends in hypoglycaemia. Degludec does not replace prandial insulin: post-meal rises are covered by a rapid analogue.

Sources

  1. AEMPS: Ficha técnica Tresiba 100 unidades/ml FlexTouch solución inyectable (2026)
  2. ADA: Standards of Care in Diabetes 2025 (2025)

ICD-10: E10 · ICD-11: 5A10

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Degludec carries a fatty acid attached to the B chain through a glutamate linker. In subcutaneous tissue the molecules assemble into long multihexamer chains that break down gradually, releasing monomers into the blood slowly and evenly. The half-life is about 25 hours, the action lasts beyond 42 hours, and steady state is reached in 2–3 days. The practical consequence is a profile that barely depends on injection timing: the AEMPS Tresiba label allows the interval between doses to be shifted when needed, keeping at least 8 hours. At the receptor degludec behaves like ordinary insulin.

Safety

Contraindications

  • Hypoglycaemia
  • Hypersensitivity to insulin or to any excipient of the product

Serious adverse effects

  • Severe hypoglycaemia with loss of consciousness and seizures
  • Hypokalaemia in overdose, up to rhythm disturbance
  • Anaphylaxis and generalised insulin allergy
  • Oedema and decompensated heart failure when combined with pioglitazone

Common adverse effects

  • Hypoglycaemia: sweating, tremor, palpitations, hunger, confusion
  • Injection site reactions: redness, swelling, itching
  • Lipohypertrophy when injections stay in one spot
  • Weight gain early in treatment

Pregnancy: can you take Insulin degludec?

Insulin does not cross the placenta and remains the mainstay of glycaemic control in pregnancy. Requirements shift by trimester: usually lower in the first, rising from the second, and falling sharply after delivery. The dose is revisited at every stage.

Breastfeeding: can you take Insulin degludec?

The label sets no restriction during breastfeeding: insulin is broken down in the infant's gut and does not reach the bloodstream. Insulin requirements often fall during lactation, so the dose is retitrated.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Label mentions8 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • ModeratePioglitazone
    «Combinación de pioglitazona e insulinas: Cuando la pioglitazona fue utilizada en combinación con insulina, se notificaron casos de insuficiencia cardiaca, especialmente en pacientes con factores de…»

    AEMPS, section 4.4 · Open on CIMA

  • anticonceptivos hormonalesclass named in the label
    «Las siguientes sustancias pueden aumentar los requerimientos de insulina: Anticonceptivos orales, tiazidas, glucocorticoides, hormonas tiroideas, simpaticomiméticos, hormona de crecimiento y danazol.»

    AEMPS, section 4.5 · Open on CIMA

  • antidiabéticos oralesclass named in the label
    «Las siguientes sustancias pueden reducir los requerimientos de insulina: Antidiabéticos orales, agonistas del receptor de GLP-1, inhibidores de la monoamino oxidasa (IMAO), betabloqueantes…»

    AEMPS, section 4.5 · Open on CIMA

  • betabloqueantesclass named in the label
    «Las siguientes sustancias pueden reducir los requerimientos de insulina: Antidiabéticos orales, agonistas del receptor de GLP-1, inhibidores de la monoamino oxidasa (IMAO), betabloqueantes…»

    AEMPS, section 4.5 · Open on CIMA

  • corticosteroidesclass named in the label
    «Las siguientes sustancias pueden aumentar los requerimientos de insulina: Anticonceptivos orales, tiazidas, glucocorticoides, hormonas tiroideas, simpaticomiméticos, hormona de crecimiento y danazol.»

    AEMPS, section 4.5 · Open on CIMA

  • IMAOclass named in the label
    «Las siguientes sustancias pueden reducir los requerimientos de insulina: Antidiabéticos orales, agonistas del receptor de GLP-1, inhibidores de la monoamino oxidasa (IMAO), betabloqueantes…»

    AEMPS, section 4.5 · Open on CIMA

  • simpaticomiméticosclass named in the label
    «Las siguientes sustancias pueden aumentar los requerimientos de insulina: Anticonceptivos orales, tiazidas, glucocorticoides, hormonas tiroideas, simpaticomiméticos, hormona de crecimiento y danazol.»

    AEMPS, section 4.5 · Open on CIMA

  • tiazidasclass named in the label
    «Las siguientes sustancias pueden aumentar los requerimientos de insulina: Anticonceptivos orales, tiazidas, glucocorticoides, hormonas tiroideas, simpaticomiméticos, hormona de crecimiento y danazol.»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Insulin degludec used for?

Insulin degludec is evaluated for the following indications with varying evidence strength: Insulin-dependent type 2 diabetes mellitus (evidence tier A), Type 1 diabetes mellitus (evidence tier A). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Insulin degludec?

Common side effects of Insulin degludec (≥ 1 in 100): Hypoglycaemia: sweating, tremor, palpitations, hunger, confusion, Injection site reactions: redness, swelling, itching, Lipohypertrophy when injections stay in one spot, Weight gain early in treatment. See the Safety section for uncommon and serious reactions.

Is Insulin degludec safe during pregnancy?

Insulin does not cross the placenta and remains the mainstay of glycaemic control in pregnancy. Requirements shift by trimester: usually lower in the first, rising from the second, and falling sharply after delivery. The dose is revisited at every stage.

Is Insulin degludec compatible with breastfeeding?

The label sets no restriction during breastfeeding: insulin is broken down in the infant's gut and does not reach the bloodstream. Insulin requirements often fall during lactation, so the dose is retitrated.

Who should not take Insulin degludec?

Insulin degludec is contraindicated in: Hypoglycaemia; Hypersensitivity to insulin or to any excipient of the product. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Insulin detemir, Insulin glargine, Insulin glulisine, Insulin human isophane (NPH), Pioglitazone, Tirzepatide, Glibenclamide, Insulin lispro