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# Novo Nordisk Gains Updated Safety Outcomes Data on Tresiba
- URL: https://www.fdaweb.com/novo-nordisk-gains-updated-safety-outcomes-data-on-tresiba/
- Published: 2018-03-26T12:00:00.000Z
- Updated: 2026-09-14T23:55:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141059

FDA has approved a Novo Nordisk supplemental NDA for Tresiba (insulin degludec injection) 100 U/mL, 200 U/mL to include data from the DEVOTE safety outcomes study. The following data from the study in patients with Type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) are now included in the label:

- Primary composite endpoint: Tresiba U-100 demonstrated no increased risk of major adverse cardiovascular events compared to insulin glargine U-100 .
- Secondary confirmatory endpoint: Tresiba U-100 demonstrated 40% significantly lower rates of severe hypoglycemia (low blood sugar) compared to insulin glargine U-100

Novo Nordisk says Tresiba is the only long-acting insulin approved for Type 1 and Type 2 diabetes in children as young as one year of age. It was approved by FDA 9/25/2015.