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Novo Nordisk's Levemir

Monica Holmberg, PharmD
Published Online: Sunday, October 1, 2006   [ Request Print ]

The FDA has approved Novo Nordisk's Levemir (insulin detemir [rDNA origin] injection) for the treatment of type 1 diabetes in adults and children and type 2 diabetes in adults.1 Levemir, a long-acting insulin analog with a relatively flat action profile, is promoted to improve glycemic control with fewer hypoglycemic events and less weight gain than other treatment options. Levemir already is available in 50 other countries.2

Mechanism of Action

Levemir works to regulate glucose metabolism through binding to insulin receptors. Thus it lowers blood glucose by assisting glucose transportation into muscle and fat and by reducing glucose output from the liver. Insulin also works to inhibit both adipocyte lipolysis and proteolysis and to enhance protein synthesis.1

Clinical Trials

Several clinical trials have evaluated the safety and efficacy of Levemir worldwide. The PREDICTIVE (Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation) trial studied the findings from the German cohorts of 10,276 diabetic patients with a primary end point of safety. After a mean follow-up of 14.5 weeks, Levemir was determined to significantly reduce hemoglobin A1C levels in both type 1 and type 2 diabetics and to significantly reduce the incidence of hypoglycemic events. Additionally, type 1 diabetics did not gain weight, and type 2 diabetics had a modest weight loss.2

Several clinical trials evaluated Levemir in adult patients with type 1 diabetes by comparing Levemir with Neutral Protamine Hagedorn (NPH) insulin and insulin glargine. At the studies' ends, reductions in hemoglobin A1C and fasting plasma glucose levels were found to be comparable in all groups.

Levemir's use in pediatric type 1 diabetic patients was evaluated in a nonblinded, randomized trial of 347 patients. Either Levemir or NPH was given once or twice daily, with insulin aspart given prior to meals. After 26 weeks, both groups were found to have achieved similar glycemic control, as demonstrated by hemoglobin A1C.

Levemir's use in adult type 2 diabetic patients was studied in a nonblinded, randomized clinical study of 476 patients. Either Levemir or NPH was given, along with 1 or 2 oral agents, such as metformin, insulin secretagogue, or an α-glucosidase inhibitor. At the end of the 24-week trial, both groups had similar reductions in hemoglobin A1C.1

Dosing

Levemir is intended for once-or twice-daily subcutaneous administration. Individual doses should be based on patient-specific needs, and dose adjustments may be necessary. For type 1 or type 2 patients with basal or basalbolus therapies, treatment with Levemir can be initiated with a unit-for-unit conversion. In patients who have not used insulin, Levemir can be initiated at 0.1 to 0.2 units per kilogram once a day or 10 units once or twice a day. As with all insulin therapy, doses and dose adjustments should be based on clinical glucose control.1

Safety

Patients with a hypersensitivity to Levemir should not use it.

As with all insulins, hypoglycemia is the most common side effect of Levemir therapy. All patients using Levemir should monitor blood glucose as directed by the prescriber. Levemir never should be used in an insulin pump or mixed with any other insulin formulations. Patients with hepatic or renal impairment may require dose modifications.1,2

Patient Education

Rotating the injection site may help to prevent reactions such as lipodystrophy, redness, itching, pain, hives, or inflammation that may occur with all insulin therapy.

Levemir is a clear, colorless solution. It should not be used if it appears discolored or contaminated.

Unopened Levemir vials should be stored at between 2° and 8°C (between 36° and 46°F) and never should be frozen. After opening, Levemir vials may be kept at room temperature (below 30°C or 86°F) for 42 days.

Unused devices such as Penfill, FlexPen, and InnoLet should be kept under refrigeration. Once used, these devices must be kept at room temperature (below 30°C or 86°F) and must not be refrigerated or stored with the needles attached.1

Dr. Holmberg is a pharmacist with Phoenix Children's Hospital, Phoenix, Ariz.

For a list of references, send a stamped, self-addressed envelope to: References Department, Attn. A. Rybovic, Pharmacy Times, Ascend Media Healthcare, 103 College Road East, Princeton, NJ 08540; or send an email request to: arybovic@ascendmedia.com.


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