FDA approved new long-acting insulin degludec for treatments of diabetes mellitus.
On September 25, 2015, the FDA has approved Tresiba (insulin degludec SC injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart SC injection) as one of the treatment options to improve glycemic controls in adults with diabetes mellitus.
Back in 2013, U.S. FDA had rejected insulin degludec from Novo Nordisk due to lack of cardiovascular outcomes data. Therefore, to reapply for approval, Novo Nordisk conducted the cardiovascular trial for insulin degludec called DEVOTE and submit temporary results to the FDA earlier this year.
The DEVOTE trial started in October 2013 and it is a Phase 3 double blind randomized trial to test the safety and efficacy of insulin degludec in comparison of insulin glargine for cardiovascular outcomes in T2DM patients. 7637 participants over the age of 50 with predefined cardiovascular problems or renal disease have been enrolled in this trial. The primary outcome measured is the time to first occurrence of major adverse cardiovascular event such as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. Secondary outcomes include number of severe hypoglycemic episodes and change in glycosylated hemoglobin (HbA1C). This ongoing trial is expected to be wrapped up in September of 2016.
According to the FDA, Tresiba is a long-acting insulin analog and dosing should be individualized based on the patients’ needs. Tresiba is administered subcutaneously (SC) once daily at any time of day due to its extended coverage. Clinical trials have shown that treatment with Tresiba provided reduction in HbA1C similarly with other previously approved long-acting insulin.
Ryzodeg 70/30 is a mixture of a long-acting insulin analog (insulin degludec) and a rapid-acting human insulin analog (insulin aspart). Ryzodeg 70/30 is administered SC once or twice daily with any main meal. Clinical trials have shown that “treatment with Ryzodeg 70/30 provided reductions in HbA1C equivalent to reductions achieved with other, previously approved long-acting or pre-mixed insulin.”2
Blood glucose monitoring is recommended with all insulin use. Modifications of doses should be done cautiously and only under medical supervision due to risk of hypoglycemia and adverse effects. The most common adverse reactions seen in clinical trials for Tresiba and Ryzodeg 70/30 were “hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site (lipodystrophy), itching, rash, edema, and weight gain.”2 Moreover, according to the FDA, Tresiba and Ryzodeg 70/30 should not be used in patients with diabetic ketoacidosis.
- Both Tresiba and Ryzodeg 70/30 provide reductions in HbA1C equivalent to reductions achieved with other previously approved long-acting or pre-mixed insulin.
- Tresiba is dosed once daily SC at any time of day and Ryzodeg 70/30 is dosed once or twice daily SC with any main meal.
- Tresiba and Ryzodeg 70/30 is still in Phase 3 clinical trials for cardiovascular outcomes.
Novo Nordisk A/S. A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects with Type 2 Diabetes at High Risk of Cardiovascular Events (FDA News Release: FDA approves two new drug treatments for diabetes mellitus. U.S. Food and Drug Administration, 25 Sep 2015. Web. 29 Sep 2015 <http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm464321.htm>