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FDA Approves Pair of Diabetes Drugs
Long-acting insulin improves blood sugar
The U.S. Food and Drug Administration approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve glucose control in adults with diabetes mellitus.
Indications: Tresiba is a long-acting insulin analog indicated to improve glycemic control in adults with type 1 and 2 diabetes mellitus. Ryzodeg 70/30 is a mixture of insulin degludec, a long-acting insulin analog, and insulin aspart, a rapid-acting human insulin analog. It is indicated to improve glycemic control in adults with diabetes mellitus.
Efficacy: In 2 active-controlled clinical trials, participants with type 1 and 2 diabetes who had inadequate blood sugar control at trial entry and were treated with Tresiba saw reductions in HbA1c in line with reductions achieved with other previously approved long-acting insulin. Similarly, in 4 active-controlled clinical trials, participants with type 1 and 2 diabetes who were exposed to Ryzodeg 70/30 who had inadequate blood sugar control at trial entry saw reductions in HbA1c equivalent to reductions with other, previously approved long-acting or pre-mixed insulin.
Pharmacokinetics: The half-life after subcutaneous administration is determined primarily by the rate of absorption from subcutaneous tissue. On average, the half-life at steady state is approximately 25 hours. The glucose lowering effect of Tresiba lasted at least 42 hours after the last of 8 once-daily injections.
Side Effects/Risks: The most common adverse reactions associated with Tresiba and Ryzodeg in clinical trials were hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site, itching, rash, edema, and weight gain. Tresiba and Ryzodeg should not be used in individuals who have increased ketones in their blood or urine.
Citation: FDA website. FDA approved two new drug treatments for diabetes mellitus. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm464321.htm. Updated September 25, 2015. Accessed September 28, 2015. Product insert at: https://www.novo-pi.com/tresiba.pdf.