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Action profile

Levemir® provides 24-hour action at a once-daily dose20,21

Action profile in patients with type 2 diabetes20

Results from a 24-hour, randomized, double-blind, parallel-group comparison of the pharmacodynamic properties of Levemir® and insulin glargine in patients with type 2 diabetes under glucose clamp conditions (N=27). A 1.4-U/kg dose was also studied in this trial, with no observed difference in pharmacodynamic profile.20

Adapted from Klein et al. 2007.20

  • As demonstrated in the above clamp study, Levemir® at a once-daily dose has a 24-hour duration of action similar to that of insulin glargine20
  • In a separate clinical study, the vast majority (93%) of patients with type 2 diabetes uncontrolled on OAD therapy took Levemir® once daily1,22

Results from PREDICTIVE 303 (N=5604), a multicenter, parallel-group clinical study evaluating the safety and efficacy of Levemir® in patients with type 2 diabetes over 26 weeks. Subgroup analyses further evaluated the efficacy and safety of Levemir® patients' previous regimens: OAD therapy (n=1874); NPH insulin ± OAD therapy (n=279); or insulin glargine ± OAD therapy (n=1337). Patients either self-titrated their Levemir® dose to target FPG levels or had their dose adjusted by a physician according to standard of care.1,10

PREDICTIVE = Predictable Results and Experience in Diabetes through Intensification and Control to Target: an International Variability Evaluation.

  1. Levemir® (insulin detemir [rDNA origin] injection) Indications and Usage

    Levemir® is indicated for once- or twice-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.

    Levemir® Important Safety Information

    Levemir® is contraindicated in patients hypersensitive to insulin detemir or one of its excipients.

    Hypoglycemia is the most common adverse effect of all insulin therapies, including Levemir®. As with other insulins, the timing of hypoglycemic events may differ among various insulin preparations. Glucose monitoring is recommended for all patients with diabetes. Levemir® is not to be used in insulin infusion pumps. Any change of insulin dose should be made cautiously and only under medical supervision. Concomitant oral antidiabetes treatment may require adjustment.

    Inadequate dosing or discontinuation of treatment may lead to hyperglycemia and, in patients with type 1 diabetes, diabetic ketoacidosis. Levemir® should not be diluted or mixed with any other insulin preparations. Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. Dose and timing of administration may need to be adjusted to reduce the risk of hypoglycemia in patients being switched to Levemir® from other intermediate or long-acting insulin preparations. The dose of Levemir® may need to be adjusted in patients with renal or hepatic impairment.

    Other adverse events commonly associated with insulin therapy may include injection site reactions (on average, 3% to 4% of patients in clinical trials) such as lipodystrophy, redness, pain, itching, hives, swelling, and inflammation.

    *Whether these observed differences represent true differences in the effects of Levemir® and NPH insulin is not known, since these trials were not blinded and the protocols (eg, diet and exercise instructions and monitoring) were not specifically directed at exploring hypotheses related to weight effects of the treatments compared. The clinical significance of the observed differences in weight has not been established.

    Please see Prescribing Information.