NOVOMEDLINK™

This page contains information about Novo Nordisk products.

For patients with type 2 diabetes, Levemir® provided effective A1C reductions & a low rate of hypoglycemia1,2

Patients converting to Levemir® from insulin glargine had2:

Low rate of overall hypoglycemia

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 to or switching from 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.2

PREDICTIVE = Predictable Results and Experience in Diabetes through Intensification and Control to Target: an International Variability Evaluation.2

Insulin-naïve patients starting on Levemir® in the same study experienced2:

  • 1.3% reduction in A1C from baseline (8.49%)
  • No major hypoglycemic events based on patient recall

In a separate clinical study, insulin-naïve patients starting on Levemir® also experienced low rates of hypoglycemia1:

  • Nearly all hypoglycemic events were minor or symptoms only
  • Minor hypoglycemia rates were 5.09 (70–90 mg/dL) and 3.16 (80–110 mg/dL) per patient-year
  • A single major hypoglycemic event was reported in the 70 to 90 mg/dL group; no major hypoglycemic events were reported in the 80 to 110 mg/dL group

Results from a 20-week, randomized, controlled, multicenter, open-label, parallel-group, treat-to-target trial using the PREDICTIVE® 303 self-titration algorithm in insulin-naive patients with type 2 diabetes, A1C ≥7% and ≤9% on OAD therapy randomized to Levemir® and OAD (1:1) to 2 different FPG titration targets (70-90 mg/dL [n=121] or 80-110 mg/dL [n=122]).1

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

Results from PREDICTIVE 303 (N=5604): a multicenter, parallel-group clinical study evaluating the efficacy and safety 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.3,4

Related Support

Learn about 24-hour action at a once-daily dose in patients with type 2 diabetes Watch Pablo Mora, MD, discuss a long-acting basal insulin analog that may help with day-to-day challenges of managing type 2 diabetes. You can also download this audio program and take it with you.

Review Levemir® clinical studies View a table of key studies and get access to published clinical data.

Up Next

Learn about the proven weight benefits of Levemir®5,6

References:

  1. Blonde L, Merilainen M, Karwe V, Raskin P; TITRATE Study Group. Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets—the TITRATE study. Diabetes Obes Metab. 2009;116:623-631.
  2. Meneghini LF, Rosenberg KH, Koenen C, Merilainen MJ, Lüddeke H-J. Insulin detemir improves glycaemic control with less hypoglycaemia and no weight gain in patients with type 2 diabetes who were insulin naïve or treated with NPH or insulin glargine: clinical practice experience from a German subgroup of the PREDICTIVE study. Diabetes Obes Metab. 2007;9(3):418-427.
  3. Selam J-L, Koenen C, Weng W, Meneghini L. Improving glycemic control with insulin detemir using the 303 Algorithm in insulin naïve patients with type 2 diabetes: a subgroup analysis of the US PREDICTIVE 303 study. Curr Med Res Opin. 2008;24(1):11-20.
  4. Meneghini L, Koenen C, Weng W, Selam J-L. The usage of a simplified self-titration dosing guideline (303 Algorithm) for insulin detemir in patients with type 2 diabetes—results of the randomized, controlled PREDICTIVE™ 303 study. Diabetes Obes Metab. 2007;9(6):902-913.
  5. Hollander P, Cooper J, Bregnhøj J, Pedersen CB. A 52-week, multinational, open-label, parallel-group, noninferiority, treat-to-target trial comparing insulin detemir with insulin glargine in a basal-bolus regimen with mealtime insulin aspart in patients with type 2 diabetes. Clin Ther. 2008,20(11):1976-1987.
  6. Rosenstock J, Davies M, Home PD, Larsen J, Koenen C, Schernthaner G. A randomized, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naïve people with type 2 diabetes. Diabetologia. 2008;51(3):408-416.

  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.

    Levemir® should not be diluted or mixed with any other insulin preparations.

    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.

    Needles and Levemir® FlexPen® must not be shared.

    Inadequate dosing or discontinuation of treatment may lead to hyperglycemia and, in patients with type 1 diabetes, diabetic ketoacidosis. 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. Less common but more serious are severe cases of generalized allergy, including anaphylactic reaction, which may be life threatening.

    *Whether these observed differences represent true differences in the effects of Levemir®, NPH insulin, and insulin glargine is not known since these trials were not blinded and the protocols (e.g., 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 click hereclick here for Prescribing Information.

FlexPen® and Levemir® are registered trademarks of Novo Nordisk.
NovoMedLink™ is a trademark of Novo Nordisk.