< Safety
For patients with type 2 diabetes with A1C levels as high as 9%1
Levemir® (insulin detemir [rDNA origin] injection) has a low rate of hypoglycemia1
In a clinical study, insulin-naïve patients starting on Levemir® experienced low rates of hypoglycemia2:
- Non-severe 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 70-90 mg/dL group; no major hypoglycemic events were reported in the 80-110 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]).2
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
*Minor= SMPG <56 mg/dL and not requiring third-party assistance; symptoms only = SMPG ≥56 mg/dL or no measurement.
Women with type 1 diabetes who were treated with Levemir® either during or while planning pregnancy showed similar rates of hypoglycemia versus NPH insulin5†
†Minor=PG <56mg/dL (BG <50mg/dL) with or without symptoms (patient able to self treat). Major=PG <56mg/dL (BG= <50mg/dL) with symptoms consistent with hypoglycemia or reversal of symptoms after food intake, glucagon, or intravenous glucose (patient unable to self treat).
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
Levemir® is contraindicated in patients with hypersensitivity to Levemir® or any of its excipients.
Glucose monitoring is essential for all patients receiving insulin therapy. Changes to an insulin regimen should be made cautiously and only under medical supervision.
Do not dilute or mix Levemir® with any other insulin or solution or use in insulin infusion pumps. Do not administer Levemir® intravenously or intramuscularly because severe hypoglycemia could occur. Needles and Levemir® FlexPen® should never be shared.
Hypoglycemia is the most common adverse reaction of insulin therapy, including Levemir®. 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. Careful glucose monitoring and dose adjustments of insulin, including Levemir®, may be necessary in patients with renal or hepatic impairment.
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Levemir®. Adverse reactions associated with Levemir® include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, rash and pruritus.
Levemir® has not been studied in children with type 2 diabetes or in children with type 1 diabetes younger than two years of age.
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 has not been established.
Whether these observed changes in weight represent true effects of Levemir® are not known since the trial was not blinded and the protocol (e.g., diet and exercise instructions and monitoring) was not specifically directed at exploring hypotheses related to weight effects of the treatments compared. The clinical significance of the observed differences has not been established.
The background risk of birth defects, pregnancy loss, or other adverse events that exists for all pregnancies is increased in pregnancies complicated by hyperglycemia. Female patients should be advised to tell their physician if they intend to become, or if they become pregnant while taking Levemir®.
In a 26-week randomized study (n=323) of Levemir® add-on to liraglutide 1.8 mg + metformin, diarrhea was the only adverse reaction reported in ≥5% of the patients treated with liraglutide 1.8 mg + metformin + Levemir® (11.7%) and greater than in patients treated with liraglutide 1.8 mg and metformin alone (6.9%).
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