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Tresiba®: SWITCH 2 Study Meets Primary Endpoint

Feb 27, 2016

New study shows reduction in hypoglycemia.

Novo Nordisk has recently revealed the results from the “SWITCH 2 randomized, double-blind, cross-over, treat-to-target trials, which compared the efficacy and safety of Tresiba (insulin degludec) and insulin glargine.” The trial itself was initiated to compare the hypoglycemia trend in patients with type 2 diabetes when treated with Tresiba or insulin glargine. What they found was that overall, Tresiba lowered rates of hypoglycemia more so than insulin glargine.


So what is Tresiba, and how is it different than insulin glargine? For starters, when compared to the 24 hours on Sanofi’s Lantus, insulin degludec has a profile that may last up to 42 hours or even potentially longer. Patients will need to inject it subcutaneously once daily and, due to its extended coverage, it will not matter whether they inject at the same time every day as with other basal insulins. This on its own is a major selling point seeing that with both Lantus and Levemir, patients were stuck to the routine window of injecting before basal insulin runs out and blood glucose starts increasing.

The Tresiba SWITCH 2 trial consisted of 721 patients who were randomized to cross-over treatment with both Tresiba and insulin glargine in combination with metformin with the timing of the injections randomized equally. The main goal of this trial was to observe the number of cases with severe hypoglycemia episodes within the maintenance period (which was 16 weeks of treatment) within each treatment period. The numbers speak for themselves on what they found between the two: “The observed rate of severe or blood glucose confirmed symptomatic hypoglycemia was 186 events per 100 patient years exposed to Tresiba® and 265 events per 100 patient years exposed to insulin glargine during the maintenance period.” This shows a reduction by 30% in patients being treated with Tresiba compared to insulin glargine.  Tresiba was safe and well tolerated by most patients.

The use of basal insulins in patients has long been a treatment option for patients with type 2 diabetes. As the disease progresses, many patients require higher doses. Most patients (approximately 90%) who have type 2 diabetes are overweight and are less sensitive to exogenous insulin, therefore requiring increased doses for glycemic control. Insulin degludec  is an ultra-long-acting basal insulin, which “forms a soluble multihexamer that slowly dissociate into monomers to produce a flat and consistent insulin action profile, with a duration of action greater than 42 hours.” Often with patients who require insulin, proper titration of dose is always a concern, which many times leads to a higher risk of hypoglycemia due to lack of proper glycemic control. Larger doses make it more painful for some patients due to the large subcutaneous depot. Insulin degludec helps combat some of these concerns.

Tresiba, although new to the market, is a promising new product with potential to help people who have diabetes. Further research is currently in process to determine its benefits and risks.

Practice Pearls:

  • Tresiba® (insulin degludec) lasts 48 hours and possibly longer in some patients.
  • Tresiba® showed greater reductions in hypoglycemic events when compared to insulin glargine.

Researched and prepared by Javeria Fayyaz, Doctor of Pharmacy Candidate LECOM, reviewed by Dave Joffe, BSPharm, CDE

“A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes (SWITCH 2).” ClinicalTrials.gov. Novo Nordisk A/S, Dec. 2015. Web. 2 Feb. 2016.

Lowes, Robert. “Medscape Log In.” Medscape. N.p., 25 Sept. 2015. Web. 02 Feb. 2016.

“Tresiba® Demonstrates Significantly Lower Rate of Hypoglycaemia than Insulin Glargine in Blinded Phase 3b Trial in People with Type 2 Diabetes.” GlobeNewswire. N.p., 29 Jan. 2016. Web. 2 Feb. 2016.