NOVOMEDLINK™

PREDICTIVE™: a low rate of hypogylcemia

A low rate of hypoglycemia observed in patients switching to Levemir®11

It is important to note that safety was the primary end point in the PREDICTIVE study. As shown in the chart below, a low rate of hypoglycemia was observed in patients switching to Levemir® from NPH insulin or insulin glargine.11

Results from the German cohort of PREDICTIVE (N=10,276), an ongoing, multicenter observational study evaluating the safety and efficacy of Levemir® in patients with diabetes over 14.5 weeks. Subgroup analyses of patients with type 2 diabetes further evaluated the safety and efficacy of Levemir® when adding or switching from OAD therapy: OAD therapy (n=1321); NPH insulin ± OAD therapy (n=251); or insulin glargine ± OAD therapy (n=260). Values shown above are based on patient recall.11

  • Insulin-naive patients starting on Levemir® had a low rate of hypoglycemia11

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.

    Please see Prescribing Information.