Levemir’s Approval Means One More Long-Acting Insulin Option for Diabetics
On June 17, 2005, Novo Nordisk received word from the U.S. Food and Drug Administration (FDA) that their long-acting insulin analog, Levemir (insulin detemir), had received approval. Levemir will join Lantus (insulin glargine) as a basal insulin option for people with diabetes who take insulin.
According to Novo Nordisk, Levemir provides up to a 24-hour duration of action and has been shown to cause little weight change.
A New Drug Application (NDA) for Levemir for pediatric indication is currently under review by the FDA. For full prescribing information, log on to www.novonordisk-us.com.
Levemir, a clear, soluble, long-acting insulin analog, is indicated for once- or twice-daily subcutaneous injection, depending on blood glucose control and insulin requirements throughout the day. Levemir provides a relatively flat action profile.
Levemir should not be mixed with any other insulins in the same syringe. Novo Nordisk reports that mixing Levemir with NovoLog (insulin aspart), a rapid-acting insulin analog, resulted in about a 40 percent reduction in AUC (area under the curve) at zero to two hours after injection and Cmax (maximum serum concentration) for NovoLog, compared to separate injections when the ratio of NovoLog to Levemir was less than 50 percent. In summary, if Levemir is mixed with other insulin preparations, the profile of action of one or both of the insulins may change.
Levemir can also be used as stand-alone therapy, added to oral antidiabetic agents, or used in combination with a rapid-acting insulin.
—C. Onufer, RN, MA, BC-ADM, CDE
Alan Moses (pictured) is the associate vice president of medical affairs for Novo Nordisk, Inc. We asked him a few questions about Levemir and its indications.
For which patient population is Levemir indicated?
Levemir is indicated for once- or twice-daily subcutaneous administration in the treatment of adult patients with type 1 and type 2 diabetes mellitus who require basal (long-acting coverage) insulin for the control of hyperglycemia. Levemir can be used with oral antidiabetic agents in type 2 diabetes and with short- or rapid-acting insulins in type 1 and type 2 diabetes. Additionally, a New Drug Application for Levemir for pediatric indication is currently under review by the FDA.
How is Levemir revolutionary for insulin-using diabetics?
Levemir is the first soluble long-acting (basal) insulin analog designed to incorporate a fatty acid directly into the insulin molecule to produce a change in the insulin absorption characteristics. The fatty acid causes the insulin molecules to stick more tightly together and thus be absorbed more slowly. In addition, the fatty acid causes the insulin to bind to the major blood protein albumin to help delay its absorption into the circulation and to delay its clearance from the circulation.
The design of this insulin analog creates an insulin that is absorbed with a reproducible and relatively flat pattern. When tested in patients with type 2 diabetes on oral agents, Levemir was able to achieve optimal mean A1C levels at the end of the study of approximately 6.6% with little or no weight gain. Additionally, Levemir is the first insulin product to obtain a PI label featuring data from “treat to target” studies in which the goal of achieving a target A1C of 7% or less, as recommended by the American Diabetes Association, was reached in clinical efficacy studies. The company’s emphasis on “treat to target” results underlines the company’s commitment to providing physicians with all of the tools necessary for delivering the best individualized insulin regimens to meet specific patient needs.
A recent abstract at the ADA says basal insulins are effective when used twice daily. What are your thoughts about Levemir being administered twice daily, and for which patients would this be most beneficial?
Levemir can be administered once or twice daily. The dose of Levemir should be adjusted according to blood glucose measurements. The dosage and frequency of administration of Levemir should be individualized based on the physician’s advice, in accordance with the needs of the patient. For patients treated with Levemir once daily, the dose should be administered with the evening meal or at bedtime. For patients who require twice-daily dosing for effective blood glucose control, the evening dose can be administered either with the evening meal, at bedtime or 12 hours after the morning dose.
As with all insulins, close glucose monitoring is recommended during the transition and in the initial weeks thereafter.
Clinical trial participants using Levemir were able to consistently achieve A1C levels of approximately 6.6% at the end of the study with little or no weight gain.
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