Insulin glulisine

Rapid-acting insulin analogue

ATC code: A10AB06

Brand names: Apidra

Updated 24 Sep 2026 · Methodology

Indications

Insulin-dependent type 2 diabetes mellitus

Second line

In type 2 diabetes glulisine is added to basal insulin for post-meal glucose control. The AEMPS Apidra label describes a preserved profile in excess body weight, and in patients with obesity that is a practical argument for it. Concurrent oral antidiabetic drugs potentiate the effect and call for revisiting the secretagogue dose – the label names them among agents that raise hypoglycaemia risk, together with ACE inhibitors. Metformin usually stays in the regimen.

Sources

ICD-10: E11.9 · ICD-11: 5A11

Type 1 diabetes mellitus

First line

Glulisine covers meals in a basal-bolus regimen and works in a pump. The AEMPS Apidra label allows injection 0–15 minutes before a meal or shortly after it and permits use from 6 years of age. The product suits situations where the amount eaten is not known in advance: the dose is given after the meal based on what was actually eaten, which helps in children and with poor appetite. Glulisine is not mixed in one syringe with insulin glargine – the label prohibits that mixture and allows only NPH, with glulisine drawn up first.

Sources

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

In glulisine, asparagine B3 is replaced by lysine and lysine B29 by glutamic acid. The product exists in solution mostly as monomers and needs no zinc for stabilisation, so it absorbs quickly without waiting for hexamers to dissociate. Onset is at 10–20 minutes, the peak around an hour, duration up to 4 hours. In people with obesity the profile stays closer to the declared one than that of human regular insulin, whose action stretches out in thick subcutaneous tissue.

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 glulisine?

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 glulisine?

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 mentions17 mentions

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

From this drug’s label

anticonceptivos hormonalesclass named in the label
«Las sustancias que podrían disminuir la actividad reductora del nivel de glucosa en sangre incluyen corticoides, danazol, diazóxido, diuréticos, glucagón, isoniazida, derivados de la fenotiazina…»
AEMPS, section 4.5 · Open on CIMA
antidiabéticos oralesclass named in the label
«Las sustancias que podrían aumentar la actividad reductora del nivel de glucosa en sangre e incrementar la susceptibilidad a una hipoglucemia son los medicamentos antidiabéticos orales, los…»
AEMPS, section 4.5 · Open on CIMA
antipsicóticosclass named in the label
«Las sustancias que podrían disminuir la actividad reductora del nivel de glucosa en sangre incluyen corticoides, danazol, diazóxido, diuréticos, glucagón, isoniazida, derivados de la fenotiazina…»
AEMPS, section 4.5 · Open on CIMA
betabloqueantesclass named in the label
«Los betabloqueantes, clonidina, sales de litio o alcohol podrían potenciar o debilitar la actividad reductora del nivel de glucosa en sangre de la insulina. La pentamidina podría causar hipoglucemia…»
AEMPS, section 4.5 · Open on CIMA
Clonidine
«Los betabloqueantes, clonidina, sales de litio o alcohol podrían potenciar o debilitar la actividad reductora del nivel de glucosa en sangre de la insulina. La pentamidina podría causar hipoglucemia…»
AEMPS, section 4.5 · Open on CIMA
Clozapine
«Las sustancias que podrían disminuir la actividad reductora del nivel de glucosa en sangre incluyen corticoides, danazol, diazóxido, diuréticos, glucagón, isoniazida, derivados de la fenotiazina…»
AEMPS, section 4.5 · Open on CIMA
corticosteroidesclass named in the label
«Las sustancias que podrían disminuir la actividad reductora del nivel de glucosa en sangre incluyen corticoides, danazol, diazóxido, diuréticos, glucagón, isoniazida, derivados de la fenotiazina…»
AEMPS, section 4.5 · Open on CIMA
Disopyramide
«Las sustancias que podrían aumentar la actividad reductora del nivel de glucosa en sangre e incrementar la susceptibilidad a una hipoglucemia son los medicamentos antidiabéticos orales, los…»
AEMPS, section 4.5 · Open on CIMA
diuréticosclass named in the label
«Las sustancias que podrían disminuir la actividad reductora del nivel de glucosa en sangre incluyen corticoides, danazol, diazóxido, diuréticos, glucagón, isoniazida, derivados de la fenotiazina…»
AEMPS, section 4.5 · Open on CIMA
fibratosclass named in the label
«Las sustancias que podrían aumentar la actividad reductora del nivel de glucosa en sangre e incrementar la susceptibilidad a una hipoglucemia son los medicamentos antidiabéticos orales, los…»
AEMPS, section 4.5 · Open on CIMA
Fluoxetine
«Las sustancias que podrían aumentar la actividad reductora del nivel de glucosa en sangre e incrementar la susceptibilidad a una hipoglucemia son los medicamentos antidiabéticos orales, los…»
AEMPS, section 4.5 · Open on CIMA
IMAOclass named in the label
«Las sustancias que podrían aumentar la actividad reductora del nivel de glucosa en sangre e incrementar la susceptibilidad a una hipoglucemia son los medicamentos antidiabéticos orales, los…»
AEMPS, section 4.5 · Open on CIMA
inhibidores de la ECAclass named in the label
«Las sustancias que podrían aumentar la actividad reductora del nivel de glucosa en sangre e incrementar la susceptibilidad a una hipoglucemia son los medicamentos antidiabéticos orales, los…»
AEMPS, section 4.5 · Open on CIMA
Lithium
«Los betabloqueantes, clonidina, sales de litio o alcohol podrían potenciar o debilitar la actividad reductora del nivel de glucosa en sangre de la insulina. La pentamidina podría causar hipoglucemia…»
AEMPS, section 4.5 · Open on CIMA
Olanzapine
«Las sustancias que podrían disminuir la actividad reductora del nivel de glucosa en sangre incluyen corticoides, danazol, diazóxido, diuréticos, glucagón, isoniazida, derivados de la fenotiazina…»
AEMPS, section 4.5 · Open on CIMA
simpaticomiméticosclass named in the label
«Las sustancias que podrían disminuir la actividad reductora del nivel de glucosa en sangre incluyen corticoides, danazol, diazóxido, diuréticos, glucagón, isoniazida, derivados de la fenotiazina…»
AEMPS, section 4.5 · Open on CIMA
Somatropin
«Las sustancias que podrían disminuir la actividad reductora del nivel de glucosa en sangre incluyen corticoides, danazol, diazóxido, diuréticos, glucagón, isoniazida, derivados de la fenotiazina…»
AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Insulin glulisine used for?

Insulin glulisine 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 glulisine?

Common side effects of Insulin glulisine (≥ 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 glulisine safe during pregnancy?

Is Insulin glulisine compatible with breastfeeding?

Who should not take Insulin glulisine?

Insulin glulisine 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.

AEMPS / CIMA

Other drugs in this group

Insulin human isophane (NPH), Insulin lispro, Linagliptin, Liraglutide, Sitagliptin, Dapagliflozin, Insulin, Metformin