Source: FDA label
| Molecular formula | C274H411N65O81S6 |
|---|---|
| Molecular weight | 6104 g/mol |
| Registered trials | 256 |
| PubChem CID | 118984462 |
| Drug class | Insulin Analog [EPC] |
| Brand names | Xultophy 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
Managing blood sugar often requires more than one type of medication working together. Insulin degludec is a long-acting insulin analog best known today as part of the combination product Xultophy 100/3.6.
Key takeaways
- Insulin degludec is a long-acting human insulin analog, paired with liraglutide in the approved product Xultophy 100/3.6.
- It is approved as an adjunct to diet and exercise for glycemic control in adults with type 2 diabetes.
- The combination product carries a boxed warning.
- Evidence includes 256 registered trials, spanning studies in both type 1 and type 2 diabetes.
- FAERS reports most commonly involve blood glucose changes and gastrointestinal symptoms.
What Insulin Degludec Is
Insulin degludec belongs to the insulin analog drug class and is combined with liraglutide, a GLP-1 receptor agonist, in Xultophy 100/3.6. Insulin and its analogs lower blood glucose by helping muscle and fat tissue take up glucose from the blood while reducing glucose production by the liver. This combination also inhibits the breakdown of fat and protein and supports protein synthesis, working alongside the GLP-1 component's separate effects on glucose regulation.
What Insulin Degludec Is Approved For
Xultophy 100/3.6, the combination containing insulin degludec and liraglutide, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The label notes limitations of use: it is not recommended with other liraglutide or GLP-1 receptor agonist products, it is not intended for diabetic ketoacidosis, and it has not been studied alongside prandial insulin. This product carries a boxed warning.
What the Evidence Shows
Across clinical research, 256 trials have been registered that involve insulin degludec or related products. Sample studies include a completed trial examining Tresiba (insulin degludec) after switching basal insulin therapy in people with type 1 or type 2 diabetes, and a phase 4 trial evaluating intensive short-term drug therapy in type 2 diabetes. A phase 3 trial also compared a related rapid-acting insulin product to insulin lispro in type 2 diabetes participants.
Reported Side Effects
FAERS data reflect reported reactions, not confirmed incidence or causation, and cannot establish that the drug caused these events. The most frequently reported terms involve glucose regulation itself, including increased blood glucose (3,991 reports), decreased blood glucose (1,352), and hypoglycemia (1,052). Gastrointestinal reports are also common, led by nausea (1,656), vomiting (1,114), and diarrhoea (1,065). Reports of off-label use (1,093) and drug ineffectiveness (1,089) appear as well, reflecting how the product is used and perceived in practice rather than a specific adverse reaction.
FAQ
What is insulin degludec used for?
Insulin degludec is combined with liraglutide in the approved product Xultophy 100/3.6, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. It is not recommended for diabetic ketoacidosis and has not been studied with prandial insulin.
How does insulin degludec work?
As an insulin analog, it helps muscle and fat tissue absorb glucose from the blood while reducing glucose production in the liver. It also limits the breakdown of fat and protein and supports protein synthesis, complementing the separate glucose-lowering action of the liraglutide component in Xultophy.
Does Xultophy 100/3.6 have a boxed warning?
Yes, the label for Xultophy 100/3.6, which contains insulin degludec and liraglutide, carries a boxed warning. Patients should review the full prescribing information with their healthcare provider for details.
What are the most commonly reported side effects of insulin degludec?
Reports submitted to FAERS most often involve changes in blood glucose, including increases, decreases, and hypoglycemia, along with gastrointestinal symptoms such as nausea, vomiting, and diarrhoea. These figures represent reported cases, not confirmed rates of occurrence or proof that the drug caused the event.
How much clinical research exists on insulin degludec?
There are 256 registered trials involving insulin degludec or related products. Examples include studies on switching basal insulin therapy in type 1 and type 2 diabetes and a phase 4 trial on intensive short-term drug therapy in type 2 diabetes.
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Sources: FDA Label (DailyMed) - Xultophy 100/3.6 FDA Adverse Event Reporting System (FAERS) ClinicalTrials.gov PubChem CID 118984462
Updated 2026-11-07