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Levemir®: Significantly less weight gain versus insulin glargine2

Levemir® demonstrated significantly less weight gain when compared with insulin glargine2

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

Additionally, less weight gain was confirmed in 12 of 12 controlled clinical trials3

  • Patients with type 1 diabetes
  • Patients with type 2 diabetes
    • Including patients previously treated with OAD therapy alone

*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.

Related Support

Learn about basal insulin and weight considerations Watch Athena Philis-Tsimikas, MD, discuss a long-acting basal insulin that may help address concerns about weight gain during insulin therapy. You can also download this audio program and take it with you.

Access diabetes management tools for patients Browse our growing library of resources for patients and educators, including a healthy eating plan, meal planning tips, and information on exercise.

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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. NDA21-536. Novo Nordisk, Inc., Princeton, NJ.

  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.

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