Approved

Insulin Degludec: Uses, Mechanism, and Side Effects

Drafted by an automated content engine from FDA, PubChem, ClinicalTrials.gov, NIH DSLD, and Open Beauty Facts data.

Molecular formulaC274H411N65O81S6
Molecular weight6104 g/mol
Registered trials255
PubChem CID118984462
Drug classInsulin Analog [EPC]
Brand namesXultophy 100/3.6
Boxed warning: The FDA label for this compound includes a boxed warning, the FDA's strongest safety warning. See the full prescribing information for details.

Mechanism of Action

12.1 Mechanism of Action XULTOPHY 100/3.6 XULTOPHY 100/3.6 is a combination product consisting of insulin degludec and liraglutide. Insulin degludec The primary activity of insulin degludec is the regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin also inhibits lipolysis and proteolysis, and enhances protein synthesis. Liraglutide Lirag

Source: FDA label

People managing type 2 diabetes often look for insulin options with a steady, predictable action profile. Insulin degludec is a long-acting insulin analog that has been studied extensively and is available in an FDA-approved combination product.

Key takeaways

  • Insulin degludec is a long-acting human insulin analog that regulates glucose metabolism.
  • It is approved as part of Xultophy 100/3.6, a combination with liraglutide, for adults with type 2 diabetes.
  • Xultophy 100/3.6 carries a boxed warning.
  • More than 250 clinical trials have registered work involving insulin degludec.
  • Reported reactions center on blood glucose changes and gastrointestinal symptoms.

What Insulin Degludec Is

Insulin degludec belongs to the insulin analog drug class. It lowers blood glucose by stimulating glucose uptake in muscle and fat tissue and by inhibiting glucose production in the liver. It also reduces the breakdown of fat and protein while supporting protein synthesis in the body.

What Insulin Degludec Is Approved For

Insulin degludec is approved in combination with liraglutide, a GLP-1 receptor agonist, under the brand name Xultophy 100/3.6. This combination is indicated alongside diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is not recommended for treating diabetic ketoacidosis and has not been studied alongside prandial insulin. The product also should not be combined with other liraglutide-containing medications or other GLP-1 receptor agonists. Xultophy 100/3.6 carries a boxed warning.

What the Evidence Shows

More than 250 clinical trials have registered research involving insulin degludec. One completed phase 3 trial examined its efficacy and safety in children and adolescents with type 1 diabetes mellitus. Another completed trial compared the drug's effects on shifting patients from twice-daily insulin glargine or detemir to once-daily insulin degludec in type 1 diabetes.

Reported Side Effects

Reported side effect data reflect adverse event reports, not confirmed rates of incidence or causation. The most frequently reported reactions involve blood glucose fluctuations, including increased blood glucose (3,929 reports), decreased blood glucose (1,336), and hypoglycaemia (1,007). Gastrointestinal symptoms are also commonly reported, including nausea (1,601), vomiting (1,069), and diarrhoea (1,038). Reports of drug ineffectiveness (1,054) and off-label use (1,050) were also noted among the top reported terms.

FAQ

What is insulin degludec used for?
Insulin degludec is approved as part of Xultophy 100/3.6, a combination with liraglutide, to improve glycemic control in adults with type 2 diabetes. It is used alongside diet and exercise rather than as a standalone lifestyle replacement. It is not recommended for diabetic ketoacidosis or in combination with other GLP-1 receptor agonists.
How does insulin degludec work?
Insulin degludec is a long-acting human insulin analog that regulates glucose metabolism. It lowers blood glucose by promoting glucose uptake in muscle and fat tissue and by reducing glucose production in the liver. It also affects fat and protein metabolism by inhibiting breakdown and supporting synthesis.
Does insulin degludec have a boxed warning?
Yes, the combination product Xultophy 100/3.6, which contains insulin degludec and liraglutide, carries a boxed warning. The specific details of the warning are part of the full prescribing information.
What are the most commonly reported side effects of insulin degludec?
The most frequently reported reactions involve blood glucose changes, including increases, decreases, and hypoglycaemia. Gastrointestinal symptoms such as nausea, vomiting, and diarrhoea are also commonly reported. These figures represent adverse event report counts, not confirmed rates of incidence or proof of causation.
How much clinical research exists on insulin degludec?
More than 250 clinical trials have registered research involving insulin degludec. This includes studies in both type 1 and type 2 diabetes populations, including pediatric and adolescent groups. Completed trials have examined comparisons with other long-acting insulins.
This page is an editorial information resource. It does not sell, prescribe, or recommend any medication. Content is editorial information, not medical advice. Talk to your doctor before any treatment decision.

Sources: FDA label (Xultophy 100/3.6) DailyMed ClinicalTrials.gov FDA FAERS PubChem

Updated 2026-08-10