FDA approved brand-new long-acting insulin degludec for treatments of diabetes mellitus.
Tresiba and Ryzodeg
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 alternatives to improve glycemic controls in grownups with diabetes mellitus.
Back in 2013, U.S. FDA had rejected insulin degludec from Novo Nordisk due to lack of cardiovascular outcomes information. For that reason, to reapply for approval, Novo Nordisk performed the cardiovascular trial for insulin degludec called DEVOTE and submit temporary results to the FDA earlier this year.
The DEVOTE trial began in October 2013 and it is a Phase 3 double blind randomized trial to test the safety and efficacy of insulin degludec in contrast of insulin glargine for cardiovascular results in T2DM patients. 7637 individuals over the age of 50 with predefined cardiovascular issues or kidney disease have actually been registered in this trial. The main result measured is the time to first occurrence of major negative cardiovascular occasion such as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. Secondary outcomes include variety of severe hypoglycemic episodes and alter in glycosylated hemoglobin (HbA1C). This ongoing trial is expected to be involved September of 2016.
See also: Inhaled Insulin Afrezza
According to the FDA, Tresiba is a long-acting insulin analog and dosing must be embellished based upon the patients’ needs. Tresiba is administered subcutaneously (SC) daily at any time of day due to its prolonged protection. Medical trials have revealed that treatment with Tresiba offered reduction in HbA1C likewise with other formerly authorized long-acting insulin.
Ryzodeg 70/30 is a mix of a long-acting insulin analog (insulin degludec) and a rapid-acting human insulin analog (insulin aspart). Ryzodeg 70/30 is administered SC one or two times everyday with any main meal. Scientific trials have actually revealed that “treatment with Ryzodeg 70/30 offered reductions in HbA1C equivalent to reductions accomplished with other, formerly approved long-acting or pre-mixed insulin.”
Blood sugar monitoring is suggested with all insulin use. Modifications of doses should be done carefully and just under medical supervision due to risk of hypoglycemia and unfavorable impacts. The most common unfavorable responses seen in medical trials for Tresiba and Ryzodeg 70/30 were “hypoglycemia, allergic reactions, injection site responses, pitting at the injection site (lipodystrophy), itching, rash, edema, and weight gain.” 2 Moreover, according to the FDA, Tresiba and Ryzodeg 70/30 need to not be used in patients with diabetic ketoacidosis.
- Both Tresiba and Ryzodeg 70/30 offer decreases in HbA1C equivalent to decreases achieved with other formerly authorized long-acting or pre-mixed insulin.
- Tresiba is dosed daily SC at any time of day and Ryzodeg 70/30 is dosed one or two times day-to-day 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>