Source: FDA label
| Molecular formula | C274H411N65O81S6 |
|---|---|
| Molecular weight | 6104 g/mol |
| Registered trials | 255 |
| 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 with insulin often means balancing effective glucose control against the risk of it dropping too low. Insulin degludec is a long-acting insulin analog developed to provide steady glucose regulation as part of diabetes management.
Key takeaways
- Insulin degludec is a long-acting human insulin analog that regulates glucose metabolism.
- It appears in the combination product Xultophy 100/3.6, paired with the GLP-1 receptor agonist liraglutide.
- This combination is indicated for adults with type 2 diabetes as an adjunct to diet and exercise.
- The label carries a boxed warning.
- More than 255 registered trials have studied insulin degludec across diabetes populations.
What Insulin Degludec Is
Insulin degludec belongs to a class of drugs known as insulin analogs. It lowers blood glucose by stimulating glucose uptake in skeletal muscle and fat while inhibiting glucose production in the liver. It also suppresses the breakdown of fat and protein and supports protein synthesis. In the Xultophy 100/3.6 formulation, it is combined with liraglutide, a GLP-1 receptor agonist that works through a separate mechanism to support glycemic control.
What Insulin Degludec Is Approved For
Xultophy 100/3.6, the combination of insulin degludec and liraglutide, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The label notes several limitations of use: it should not be paired with other liraglutide or GLP-1 receptor agonist products, it is not recommended for treating diabetic ketoacidosis, and it has not been studied alongside prandial insulin. This product carries a boxed warning.
What the Evidence Shows
Insulin degludec has been studied across more than 255 registered clinical trials. One completed phase 4 trial compared insulin degludec with insulin glargine U100 in adults with type 1 diabetes crossing multiple time zones. A separate ongoing phase 4 trial is evaluating insulin pump therapy against multiple daily injections of insulin for glyco-metabolic control in people with type 1 diabetes.
Reported Side Effects
Reports submitted to the FDA Adverse Event Reporting System reflect counts of reported reactions, not confirmed incidence or proven causation. The most frequently reported issues involve glucose regulation itself, including increased blood glucose (3,929 reports), decreased blood glucose (1,336), and hypoglycemia (1,007). Gastrointestinal reactions are also common, with nausea (1,601), vomiting (1,069), and diarrhoea (1,038) among the top reports. Reports of drug ineffectiveness (1,054) and off label use (1,050) were also frequently logged.
FAQ
What is insulin degludec used for?
Insulin degludec is used in the combination product Xultophy 100/3.6, alongside liraglutide, to improve blood sugar control in adults with type 2 diabetes. It is meant to be used together with diet and exercise, not as a standalone treatment. It is not recommended for diabetic ketoacidosis or for use with other GLP-1 receptor agonist products.
How does insulin degludec work?
Insulin degludec regulates glucose metabolism by helping muscle and fat tissue absorb glucose from the blood while reducing glucose production by the liver. It also limits the breakdown of fat and protein and promotes protein synthesis. This mirrors the natural actions of insulin in the body.
Does insulin degludec have a boxed warning?
Yes, the labeling for Xultophy 100/3.6, which contains insulin degludec and liraglutide, includes a boxed warning. Patients and caregivers should review the full prescribing information for details.
What are the most commonly reported side effects of insulin degludec?
The most frequently reported issues involve changes in blood glucose levels, including both increases and decreases, as well as hypoglycemia. Gastrointestinal effects such as nausea, vomiting, and diarrhoea are also commonly reported. These figures come from adverse event reports and reflect reported counts rather than confirmed rates of occurrence.
How much clinical research exists on insulin degludec?
More than 255 clinical trials have registered insulin degludec as a study drug. These trials span different diabetes types and study designs, including comparisons with other long-acting insulins and evaluations of delivery methods like insulin pumps.
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Sources: FDA Label (DailyMed) ClinicalTrials.gov FDA Adverse Event Reporting System (FAERS) PubChem
Updated 2026-09-19