Novo Nordisk's Levemir

The FDA has approved Novo Nordisk'sLevemir (insulin detemir [rDNAorigin] injection) for the treatment oftype 1 diabetes in adults and childrenand type 2 diabetes in adults.¹ Levemir,a long-acting insulin analog with a relativelyflat action profile, is promoted toimprove glycemic control with fewerhypoglycemic events and less weightgain than other treatment options.Levemir already is available in 50 othercountries.²

Mechanism of Action

Levemir works to regulate glucosemetabolism through binding to insulinreceptors. Thus it lowers blood glucoseby assisting glucose transportation intomuscle and fat and by reducing glucoseoutput from the liver. Insulin alsoworks to inhibit both adipocyte lipolysisand proteolysis and to enhance proteinsynthesis.¹

Clinical Trials

Several clinical trials have evaluatedthe safety and efficacy of Levemirworldwide. The PREDICTIVE (PredictableResults and Experience in Diabetesthrough Intensification andControl to Target: An InternationalVariability Evaluation) trial studied thefindings from the German cohorts of10,276 diabetic patients with a primaryend point of safety. After a mean follow-up of 14.5 weeks, Levemir wasdetermined to significantly reducehemoglobin A1C levels in both type 1and type 2 diabetics and to significantlyreduce the incidence of hypoglycemicevents. Additionally, type 1diabetics did not gain weight, and type2 diabetics had a modest weight loss.²

Several clinical trials evaluated Levemirin adult patients with type 1 diabetes bycomparing Levemir with Neutral ProtamineHagedorn (NPH) insulin andinsulin glargine. At the studies' ends,reductions in hemoglobin A1C and fastingplasma glucose levels were found to becomparable in all groups.

Levemir's use in pediatric type 1 diabeticpatients was evaluated in a nonblinded,randomized trial of 347 patients.Either Levemir or NPH was givenonce or twice daily, with insulin aspartgiven prior to meals. After 26 weeks,both groups were found to haveachieved similar glycemic control, asdemonstrated by hemoglobin A1C.

Levemir's use in adult type 2 diabeticpatients 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 asmetformin, insulin secretagogue, or an α-glucosidase inhibitor. At the end of the24-week trial, both groups had similarreductions in hemoglobin A1C.¹

Dosing

Levemir is intended for once-ortwice-daily subcutaneous administration.Individual doses should be basedon patient-specific needs, and dose adjustmentsmay be necessary. For type1 or type 2 patients with basal or basalbolustherapies, treatment with Levemircan be initiated with a unit-for-unitconversion. In patients who have notused insulin, Levemir can be initiatedat 0.1 to 0.2 units per kilogram once aday or 10 units once or twice a day. Aswith all insulin therapy, doses and doseadjustments should be based on clinicalglucose control.¹

Safety

Patients with a hypersensitivity toLevemir should notuse it.

As with all insulins,hypoglycemia is themost common sideeffect of Levemir therapy.All patients usingLevemir should monitorblood glucose as directedby the prescriber.Levemir never shouldbe used in an insulinpump or mixed withany other insulin formulations.Patients withhepatic or renal impairmentmay require dosemodifications.^1,2

Patient Education

Rotating the injectionsite may help toprevent reactions suchas lipodystrophy, redness, itching, pain,hives, or inflammation that may occurwith all insulin therapy.

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

Unopened Levemir vials should bestored at between 2° and 8°C (between36° and 46°F) and never should be frozen.After opening, Levemir vials maybe kept at room temperature (below30°C or 86°F) for 42 days.

Unused devices such as Penfill,FlexPen, and InnoLet should be keptunder refrigeration. Once used, thesedevices must be kept at room temperature(below 30°C or 86°F) and mustnot be refrigerated or stored with theneedles attached.¹

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

For a list of references, send a stamped,self-addressed envelope to: ReferencesDepartment, Attn. A. Rybovic, PharmacyTimes, Ascend Media Healthcare, 103 CollegeRoad East, Princeton, NJ 08540; or send an emailrequest to: arybovic@ascendmedia.com.