Insulin aspart

ATC code

A10AB05

Therapeutic class

Insulin and analogues, fast-acting · Insulins and analogues for injection, fast-acting

Forms

injectable solution

Brand names

NOVOLOG (US) · FIASP (ES) · Dazparda (EU) · NovoRapid (EU)

Overall confidence

high

Regulatory sources consulted

openfda-label-5907ee0c-c7d5-4e1c-9c12-8390ccb34c42
ema-epar-EMEA/H/C/006187
aemps-cima-1161160001
PubMed PMID:37156252 ↗
PubMed PMID:40482670 ↗
PubMed PMID:35546450 ↗
PubMed PMID:36623517 ↗
PubMed PMID:37863084 ↗
OpenFDA · A10AB05
RxNorm rxcui 51428 ↗

Approved indications

Treatment of diabetes mellitus to improve glycemic control in adults, adolescents, and children aged 1 year and above.

Contraindications

Absolute

During episodes of hypoglycemia.
Hypersensitivity to insulin aspart or one of its excipients.

Clinical warnings

Major warning · Hypoglycemia: Is the most common adverse reaction of all insulins. It can occur due to excessive dosage, mismatch with carbohydrate intake, or exercise. Requires strict glucose monitoring and patient education. — FDA
Hypokalemia: All insulins can cause a shift of potassium from the extracellular to the intracellular space, potentially leading to hypokalemia. Monitor in at-risk patients. — FDA

Drug interactions

HighAgents that increase the risk of hypoglycemiaMultiple
Mechanism: Additive hypoglycemic effect or increased insulin sensitivity. Includes: other antidiabetics, ACE inhibitors, ARBs, fibrates, fluoxetine, MAOIs, salicylates, somatostatin analogs.
Recommendation: May require a reduction in insulin dose and more frequent glucose monitoring.
FDA label
ModerateAgents that decrease the blood glucose-lowering effectMultiple
Mechanism: Hyperglycemic effect that counteracts the action of insulin. Includes: corticosteroids, diuretics, estrogens, glucagon, niacin, atypical antipsychotics, sympathomimetics, thyroid hormones.
Recommendation: May require an increase in insulin dose and more frequent glucose monitoring.
FDA label
HighBeta-blockersC07
Mechanism: Mask the adrenergic symptoms of hypoglycemia (e.g., tachycardia, tremor) and may potentiate or weaken the effect of insulin.
Recommendation: Increase the frequency of glucose monitoring. Educate the patient about neuroglycopenic symptoms of hypoglycemia (e.g., confusion, dizziness).
FDA label

Adverse events

Common (≥1%)

hypoglycemia · allergic reactions · injection site reactions · lipodystrophy · rash · pruritus

Rare but serious

severe hypoglycemia · anaphylaxis · hypokalemia

Pregnancy and lactation

Available data from randomized controlled trials (e.g., the EXPECT trial) have not reported an association with major birth defects or adverse maternal/fetal outcomes. Poorly controlled diabetes in pregnancy poses a risk to the mother and fetus. It can be used during pregnancy if clinically needed.

Recent literature (PubMed)

Effect of once-weekly semaglutide versus thrice-daily insulin aspart, both as add-on to metformin and optimized insulin glargine treatment in participants with type 2 diabetes (SUSTAIN 11): A randomized, open-label, multinational, phase 3b trial.
Kellerer M, et al. · Diabetes Obes Metab · 2022 · Relevance 5/5
En pacientes con DM2 con insulina basal optimizada, la semaglutida semanal demostró una mayor reducción de HbA1c (-1.5% vs -1.2%) y una pérdida de peso significativa (-4.1 kg vs +2.8 kg) en comparación con tres inyecciones diarias de insulina asparta. La insulina asparta sirvió como el comparador activo estándar para la intensificación del tratamiento prandial.
Insulin degludec versus insulin detemir, both in combination with insulin aspart, in the treatment of pregnant women with type 1 diabetes (EXPECT): an open‑label, multinational, randomised, controlled, non-inferiority trial.
Mathiesen ER, et al. · Lancet Diabetes Endocrinol · 2023 · Relevance 5/5
Este ensayo de no inferioridad en mujeres embarazadas con DM1 demostró que la insulina degludec no fue inferior a la detemir como insulina basal. En ambos grupos, la insulina asparta se utilizó como la insulina prandial estándar, confirmando su papel y seguridad en el manejo de la diabetes durante el embarazo.
Once-weekly IcoSema versus multiple daily insulin injections in type 2 diabetes management (COMBINE 3): an open-label, multicentre, treat-to-target, non-inferiority, randomised, phase 3a trial.
Billings LK, et al. · Lancet Diabetes Endocrinol · 2025 · Relevance 5/5
Este estudio compara una combinación semanal fija de insulina icodec y semaglutida (IcoSema) con un régimen basal-bolo tradicional (insulina glargina + insulina asparta). La insulina asparta forma parte del brazo de control, representando el estándar de cuidado actual para la terapia de inyecciones múltiples diarias.
Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial.
Mathieu C, et al. · Lancet · 2023 · Relevance 4/5
El ensayo ONWARDS 4 comparó la insulina basal semanal (icodec) con la diaria (glargina U100) en pacientes con DM2 en régimen basal-bolo. La insulina asparta fue la insulina de bolo utilizada en ambos brazos, demostrando no inferioridad en el control de HbA1c y consolidando el papel de asparta como componente prandial estándar en regímenes de tratamiento intensivo.
Once-weekly insulin icodec versus once-daily insulin degludec as part of a basal-bolus regimen in individuals with type 1 diabetes (ONWARDS 6): a phase 3a, randomised, open-label, treat-to-target trial.
Russell-Jones D, et al. · Lancet · 2023 · Relevance 4/5
En pacientes con DM1, la insulina basal semanal (icodec) no fue inferior a la diaria (degludec) en la reducción de HbA1c, pero se asoció con un mayor riesgo de hipoglucemia. La insulina asparta fue la insulina prandial en ambos grupos, sirviendo como el estándar de cuidado para el control de las comidas.