Levemir® (insulin detemir)

• Class: insulin analog.
• For: treatment of people with type 1 or type 2 diabetes.
• What time of day? The recommended time for administration is in the evening when starting; twice-daily dosing is advised ("If the desired pre-dinner target level cannot be reached, consider adding a second dose in the morning according to individual needs.")
• Route of Administration: subcutaneous.
• Action: long-acting insulin.
• Appearance: clear and colorless.
• Mixing: "If Levemir is mixed with other insulin preparations the profile of action of one or both individual components will change. Mixing Levemir with a rapid acting insulin analogue like insulin aspart, results in an action profile with a lower and delayed maximum effect compared to separate injections. Therefore, mixing of rapid acting insulin with Levemir should be avoided." ¹
• Manufacturer: Novo Nordisk.
• Status: Available.
• Other drugs with approximately the same duration of action: Ultralente, insulin glargine (Lantus).

FDA Approves Levemir(R) (insulin detemir [rDNA Origin] Injection) - a New, Long-Acting Insulin Treatment for Diabetes
Friday June 17, 1:49 pm ET

First insulin analog product to obtain treat-to-target data in label

PRINCETON, N.J., June 17 /PRNewswire-FirstCall/ -- Novo Nordisk Inc. (NYSE: NVO - News) announced today that the U.S. Food and Drug Administration (FDA) has approved Levemir® (insulin detemir [rDNA origin] injection) for the treatment of diabetes mellitus (type 1 and type 2). Levemir is a novel, long- acting form of insulin that provides up to a 24-hour duration of action and has been shown to cause little weight change.

"Experts agree there is a significant need for consistent good control of patients' glucose levels, which is associated with a reduced risk of diabetes complications," said Peter Aurup, M.D., Vice President of the Clinical Development, Medical, and Regulatory Affairs department. "The results seen to date with Levemir affirm the value that the product will provide to patients who struggle to manage their diabetes."

Additionally, a New Drug Application (NDA) for Levemir for pediatric indication is currently under review by the FDA.

The safety and efficacy of Levemir given once or twice daily was compared to NPH human insulin or insulin glargine in controlled clinical studies involving a total of 6004 patients with diabetes (3724 with type 1, and 2280 with type 2). In one study, a treat-to-target efficacy study of 475 patients using Levemir or NPH insulins, 70 percent of those treated with Levemir achieved an A1C of approximately 6.6 percent, which meets the target level recommended by the American Diabetes Association. There was no significant difference between the two treatment arms. In other studies, Levemir achieved a level of glycemic control similar to that provided by other basal insulins, as measured by A1C.(2)

About Levemir

Levemir 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 can be used in monotherapy, added to oral anti-diabetic agents, or used in combination with a rapid-acting insulin. Levemir has already been approved for use in 37 countries worldwide, including countries throughout Europe. As of January 2005, approximately 88,075 patients have been treated with Levemir.

Hypoglycemia is the most common adverse effect of insulin therapy, including Levemir. Adverse events commonly associated with human insulin therapy include allergic reactions, injection site reaction, lipodystrophy, pruritus, and rash. Levemir is contraindicated in patients hypersensitive to insulin detemir or its excipients…

Also See:

(1) SPC (Summary of Product Characteristics) in the UK
Levemir From the manufacturer, Novo Nordisk.
Levemir Discussion Forum at Diabetes.Blog.com
Patient Information Sheet (PDF file). From the FDA.