Starting patients on Levemir®

Starting dose: When initiating Levemir®, start insulin-naïve patients with type 2 diabetes on 10 units once-dailya dosage or 0.1 to 0.2 units/kg daily dosage with the evening meal or at bedtime and titrate accordingly.1

 

Titration after assessing mean 3-Day FPG (mg/dL)

Levemir® titration after assessing mean 3-­‐day FPG

Physician-directed patient self-titrationb: For patients taking Levemir® once-dailya, the dose can be adjusted to reach FPG goals: 70-90 mg/dL or 80-110 mg/dL, as seen in the TITRATE study.2

Dose Adjustments: Can be made every third day based on an average of 3 consecutive FPG values.2

aLevemir® can be dosed once or twice daily. 

bClinical judgment should be used for dose adjustments and to account for hypoglycemia. The dose of Levemir® should be adjusted to achieve glycemic targets.



 

The TITRATE™ study was exclusively once-dailya treatment with Levemir® in patients with type 2 diabetes2

  • Majority of patients achieved the ADA–recommended target of A1C <7%2,3
  • Average insulin doses at the end of trial: 0.57 units/kg (70-90 mg/dL group) and 0.51 units/kg (80-110 mg/dL group)2
  • Low rates of hypoglycemia2
    • 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 groupc

cMinor= SMPG <56 mg/dL and not requiring third-party assistance.
Major= requiring third-party assistance.



 

Converting Patients is Simple

Converting from insulin glargine

When converting from insulin glargine, convert unit-to-unit to Levemir®1

Converting from NPH insulin

The change can be done on a unit-to-unit basis; however, some patients with type 2 diabetes may require more Levemir® than NPH insulin, as observed in 1 trial1


 

Related Prescribing Topics:

Selected Important Safety Information

Contraindications

  • Levemir® is contraindicated in patients with hypersensitivity to Levemir® or any of its excipients.

Warnings and Precautions

  • Dosage adjustment and monitoring: Monitor blood glucose in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment of concomitant anti-diabetic treatment.
  • Administration: Do not dilute or mix with any other insulin or solution. Do not administer subcutaneously via an insulin pump, intramuscularly, or intravenously because severe hypoglycemia can occur. Needles, insulin pens, or syringes should never be shared.

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

  • Levemir® (insulin detemir [rDNA origin] injection) is indicated to improve glycemic control in adults and children with diabetes mellitus.

Important Limitations of Use

  • Levemir® is not recommended for the treatment of diabetic ketoacidosis. Intravenous rapid-acting or short-acting insulin is the preferred treatment for this condition.

Important Safety Information

Contraindications

  • Levemir® is contraindicated in patients with hypersensitivity to Levemir® or any of its excipients.

Warnings and Precautions

  • Dosage adjustment and monitoring: Monitor blood glucose in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in the insulin dose or an adjustment of concomitant anti-diabetic treatment.

  • Administration: Do not dilute or mix with any other insulin or solution. Do not administer subcutaneously via an insulin pump, intramuscularly, or intravenously because severe hypoglycemia can occur. Needles, insulin pens, or syringes should never be shared.

  • Hypoglycemia: Hypoglycemia is the most common adverse reaction of insulin therapy and may be life-threatening. When a GLP-1 receptor agonist is used in combination with Levemir®, the Levemir® dose may need to be lowered or more conservatively titrated to minimize the risk of hypoglycemia.

  • Hypersensitivity and allergic reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Levemir®.

  • Renal and hepatic Impairment: Careful glucose monitoring and dose adjustments of insulin, including Levemir®, may be necessary in patients with renal or hepatic impairment.
  • Drug Interactions: Some medications may alter insulin requirements and subsequently increase the risk for hypoglycemia or hyperglycemia.
  • Fluid retention and heart failure with concomitant use of PPAR-gamma agonists: Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including Levemir®. Patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of the TZD must be considered.

Adverse Reactions

  • Adverse reactions associated with Levemir® include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, rash, pruritus, and if taken with GLP-1 receptor agonist, diarrhea.

Use in Specific Populations

  • Levemir® has not been studied in children with type 2 diabetes or in children with type 1 diabetes who are younger than 2 years of age.

  • The background risk of birth defects, pregnancy loss, or other adverse events that exists for all pregnancies is increased in pregnancies complicated by hyperglycemia.

Whether these observed weight results represent true effects of Levemir® and other therapies are not known since the trial was not blinded, and the protocol (eg, diet and exercise instructions and monitoring) was not specifically directed at exploring hypotheses related to weight effects of the treatments evaluated. The clinical significance of these observed effects has not been established.

Please click here for Prescribing Information.

 

References

  1. Levemir [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2013.
  2. 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.
  3. American Diabetes Association. Standards of medical care in diabetes–2014. Diabetes Care. 2014;37(suppl 1):S14-S80.