ISSUE 1483
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The FDA has approved insulin degludec (Tresiba – Novo Nordisk) for treatment of adults with type 1 or type 2 diabetes. Insulin degludec is the third long-acting human insulin analog to be approved by the FDA; insulin detemir (Levemir) and insulin glargine (Lantus, Toujeo) were approved earlier.1,2
Like other long-acting human insulin analogs, insulin degludec is synthesized using recombinant DNA technology. It forms multihexamers in subcutaneous tissue, which delays its absorption, and binds to circulating albumin, which delays its elimination and results in a prolonged duration of action (>42 hours).3
CLINICAL STUDIES — Approval of insulin degludec was based on the results of nine open-label, active-controlled trials, which are summarized in the package insert. In eight of the trials,
... more- Drugs for type 2 diabetes. Treat Guidel Med Lett 2014; 12:17.
- Concentrated insulin glargine (Toujeo) for diabetes. Med Lett Drugs Ther 2015; 57:69.
- H Haahr and T Heise. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin Pharmacokinet 2014; 53:787.
- S Heller et al. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet 2012; 379:1489.
- B Zinman et al. Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: a 1-year, randomized, treat-to-target trial (BEGIN Once Long). Diabetes Care 2012; 35:2464.
- L Meneghini et al. The efficacy and safety of insulin degludec given in variable once-daily dosing intervals compared with insulin glargine and insulin degludec dosed at the same time daily: a 26-week, randomized, open-label, parallel-group, treat-to-target trial in individuals with type 2 diabetes. Diabetes Care 2013; 36:858.
- A Philis-Tsimikas et al. Effect of insulin degludec versus sitagliptin in patients with type 2 diabetes uncontrolled on oral antidiabetic agents. Diabetes Obes Metab 2013; 15:760.
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