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For patients with type 2 diabetes with A1C levels as high as 9%, a majority of patients achieved goal (A1C <7%)1

Substantial reductions in A1C (70–90 mg/dL group)1

Representation of Levemir mechanism of action

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-naïve 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

At study end, in the 80 to 110 mg/dL group, 55% of patients achieved goal (A1C <7%), with a mean A1C decrease of 0.9%. The mean A1C was 7%.1

Low rates of hypoglycemia

  • 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

*Minor = SMPG <56 mg/dL and not requiring third-party assistance; symptoms only = SMPG ≥56 mg/dL or no measurement.

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.

Help your patients set goals Use these interactive tools to help patients design diabetes management strategies to suit their individual needs.

Up Next

See how Levemir® reduces A1C with a low rate of hypoglycemia1

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. American Diabetes Association. Standards of medical care in diabetes–2011. Diabetes Care. 2011;34(suppl 1):S11-S61.
  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.

  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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