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For patients with type 2 diabetes,

The proven weight benefits of Levemir®1-2

Levemir® demonstrated significantly less weight gain* when compared with insulin glargine1-2

In a 52-week clinical study, patients with type 2 diabetes gained 26% less weight with Levemir® than with insulin glargine.2

Levemir® demonstrates less weight gain* than insulin glargine

A 52-week, multinational, open-label, parallel-group, treat-to-target trial using a noninferiority design. Subjects diagnosed with type 2 diabetes ≥12 months on any OAD therapy or on any insulin regimen with or without OAD therapy for >4 months were randomized 2:1 to the Levemir® and insulin glargine treatment arms, respectively. A total of 323 patients were randomized, 257 completed the study. In both treatment groups, insulin aspart was administered as a mealtime insulin.2

  • Less weight gain was confirmed in 12 of 12 controlled clinical trials4
    • Patients with type 1 diabetes
    • Patients with type 2 diabetes
    • Patients previously treated with OAD therapy alone
eLearning Presentation


Observed weight change

Observed weight change with Levemir®

Results from the German cohort of PREDICTIVE (N=10,276), a 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 (n=1321), NPH insulin ± OAD therapy (n=251), or insulin glargine ± OAD therapy (n=260).5

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

*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 (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.

A retrospective analysis showed weight benefits for overweight or obese patients with type 2 diabetes when starting Levemir®6

Levemir® weight change: retrospective analysis

Analysis of data from a 20-week, multinational, open-label, 3-arm, parallel-group, treat-to-treat trial of once-daily Levemir® + OAD therapy vs once-daily NPH insulin + OAD therapy (N=331) insulin-naïve patients were randomized to receive either morning or evening Levemir® or evening NPH insulin.3,6

  • In a retrospective analysis of a separate 26-week study, patients with a mean baseline BMI >30 kg/m2 experienced a beneficial weight change7

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.7,8

With Levemir®, your patients may experience less weight gain.1,2* Learn more about the benefits of Levemir®

References:

  1. 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.
  2. 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.
  3. Data on file, Novo Nordisk, Inc., Princeton, NJ.
  4. Data on file. NDA21-536. Novo Nordisk, Inc., Princeton, NJ.
  5. 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.
  6. Philis-Tsimikas A, Koenen C, Pederson CB, Thorsteinsson B. Use of insulin detemir once-daily results in less weight gain compared with the use of NPH insulin, particularly in obese subjects with type 2 diabetes [abstract 0979]. Diabetologia. 2007;50(suppl 1):S404.
  7. 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.
  8. 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.

  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 see Prescribing InformationPrescribing Information.

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