Drug updated on 9/4/2024
Dosage Form | Injection (subcutaneous; 300 units/3 mL, 600 units/3 mL, 1000 units/10 mL) |
Drug Class | Insulin analogs |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.
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Summary
- Tresiba (insulin degludec) is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.
- This summary is based on the review of 20 systematic review(s)/meta-analysis(es). [1-20]
- Insulin degludec (IDeg) and insulin glargine U300 (IGla-300) show comparable effectiveness in reducing HbA1c levels in both type 1 and type 2 diabetes patients, with a mean difference of 0.07% (95% CI 0.06 - 0.19; p = 0.29).
- IDegLira, a combination of insulin degludec and liraglutide, demonstrates significant HbA1c reduction compared to insulin alone or GLP-1 agonists, with additional improvements in fasting plasma glucose (FPG) and self-measured plasma glucose (SMPG).
- Insulin icodec provides a superior HbA1c reduction compared to other basal insulins, with a mean difference of -0.17% (95% CI -0.28 to -0.06; p = 0.003), though it shows no significant difference in FPG reduction.
- No significant difference in body weight change is observed between IDegLira and control groups, while insulin glargine U300 is associated with less weight gain compared to other basal insulins.
- Comparable rates of any hypoglycemia were observed between IDeg and IGla-300 (rate ratio 1.02; 95% CI 0.8 - 1.3; p = 0.87). Insulin degludec showed lower rates of overall and nocturnal hypoglycemia compared to insulin glargine and insulin detemir.
- No significant differences in adverse events or serious adverse events were reported between IDegLira and control groups. Insulin icodec presented a higher incidence of level 1 hypoglycemia but had a safety profile comparable to glargine U100 with higher adverse events compared to degludec.
- IDegLira was associated with gastrointestinal side effects, while insulin icodec demonstrated similar hypoglycemia rates in type 2 diabetes but a higher incidence in type 1 diabetes compared to degludec.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Tresiba (insulin degludec) Prescribing Information. | 2022 | Novo Nordisk Inc., Plainsboro, NJ |