FDA Approved Metabolic & Weight Loss

Insulin degludec / liraglutide (IDegLira)

also known as: Xultophy, Xultophy 100/3.6, IDegLira

Novo Nordisk's fixed-ratio insulin/GLP-1 combo pen (Xultophy, FDA 2016) — 100 units/mL insulin degludec + 3.6 mg/mL liraglutide; simplifies T2DM therapy intensification into a single daily injection with additive glycemic benefit and less weight gain than basal insulin alone.

A fixed-ratio combination pen of insulin degludec (100 units/mL) and liraglutide (3.6 mg/mL) administered once daily, FDA-approved as Xultophy in 2016 for type 2 diabetes inadequately controlled on basal insulin or liraglutide alone; the combination leverages the complementary mechanisms of basal insulin (sustained glucose lowering) and GLP-1 agonism (glucose-dependent insulin secretion, appetite suppression) to achieve greater A1C reduction than either agent alone with mitigated weight gain and lower hypoglycemia risk.

Mechanism of action

Dual mechanism: insulin degludec provides sustained basal insulin receptor agonism; liraglutide provides GLP-1 receptor agonism (glucose-dependent insulin secretion, glucagon suppression, delayed gastric emptying, central appetite suppression). The fixed-ratio pen delivers both at a constant ratio with each dose increment.

Primary uses

  • Type 2 diabetes mellitus inadequately controlled on basal insulin or liraglutide monotherapy

Typical dosing

16–50 dose units once daily (subcutaneous)

1 dose unit = 1 unit degludec + 0.036 mg liraglutide. Max daily dose 50 units.

Regulatory status

FDA-approved November 2016 as Xultophy 100/3.6 (Novo Nordisk) for T2DM uncontrolled on basal insulin or liraglutide alone. EMA-approved 2014.

References

  1. [fda-pi] FDA. Xultophy 100/3.6 (insulin degludec and liraglutide) prescribing information. Novo Nordisk, updated 2024.
  2. [pubmed] Gough SCL, et al. "Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone (DUAL I)." Lancet Diabetes Endocrinol, 2014;2:885-893.

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Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.