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 DrugAdministration (FDA) that their long-acting insulin analog, Levemir (insulindetemir), had received approval. Levemir will join Lantus (insulin glargine) asa basal insulin option for people with diabetes who take insulin.

According to Novo Nordisk, Levemir provides up to a 24-hour duration ofaction and has been shown to cause little weight change.

A New Drug Application (NDA) for Levemir for pediatric indication iscurrently under review by the FDA. For full prescribing information, log on to www.novonordisk-us.com.

About Levemir

Levemir, a clear, soluble, long-acting insulin analog, is indicated for once-or twice-daily subcutaneous injection, depending on blood glucose control andinsulin requirements throughout the day. Levemir provides a relatively flataction profile.

Levemir should not be mixed with any other insulins in the same syringe. NovoNordisk reports that mixing Levemir with NovoLog (insulin aspart), arapid-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 (maximumserum concentration) for NovoLog, compared to separate injections when the ratioof NovoLog to Levemir was less than 50 percent. In summary, if Levemir is mixedwith other insulin preparations, the profile of action of one or both of theinsulins may change.

Levemir can also be used as stand-alone therapy, added to oral antidiabeticagents, or used in combination with a rapid-acting insulin.

—D. Trecroci
—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 inthe treatment of adult patients with type 1 and type 2 diabetes mellitus whorequire basal (long-acting coverage) insulin for the control of hyperglycemia.Levemir can be used with oral antidiabetic agents in type 2 diabetes and withshort- or rapid-acting insulins in type 1 and type 2 diabetes. Additionally, aNew Drug Application for Levemir for pediatric indication is currently underreview by the FDA.

How is Levemir revolutionary for insulin-using diabetics?

Levemir is the first soluble long-acting (basal) insulin analog designed toincorporate a fatty acid directly into the insulin molecule to produce a changein the insulin absorption characteristics. The fatty acid causes the insulinmolecules to stick more tightly together and thus be absorbed more slowly. Inaddition, the fatty acid causes the insulin to bind to the major blood proteinalbumin to help delay its absorption into the circulation and to delay itsclearance from the circulation.

The design of this insulin analog creates an insulin that is absorbed with areproducible and relatively flat pattern. When tested in patients with type 2diabetes on oral agents, Levemir was able to achieve optimal mean A1C levels atthe 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 labelfeaturing data from “treat to target” studies in which the goal of achievinga target A1C of 7% or less, as recommended by the American Diabetes Association,was reached in clinical efficacy studies. The company’s emphasis on “treatto target” results underlines the company’s commitment to providingphysicians with all of the tools necessary for delivering the bestindividualized insulin regimens to meet specific patient needs.

A recent abstract at the ADA says basal insulins are effective when usedtwice daily. What are your thoughts about Levemir being administered twicedaily, and for which patients would this be most beneficial?

Levemir can be administered once or twice daily. The dose of Levemir shouldbe adjusted according to blood glucose measurements. The dosage and frequency ofadministration of Levemir should be individualized based on the physician’sadvice, in accordance with the needs of the patient. For patients treated withLevemir once daily, the dose should be administered with the evening meal or atbedtime. For patients who require twice-daily dosing for effective bloodglucose control, the evening dose can be administered either with the eveningmeal, at bedtime or 12 hours after the morning dose.

As with all insulins, close glucose monitoring is recommended during thetransition and in the initial weeks thereafter.

Levemir Factoid

Clinical trial participants using Levemir were able toconsistently achieve A1C levels of approximately 6.6% at the end of the studywith little or no weight gain.

Source: Novo Nordisk

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