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Prescribing Information


The efficacy and safety of Levemir® (insulin detemir) have been extensively studied and well established, with over 19,000 patient experiences† in 23 studies. The links below will provide you access to the published clinical data on PubMed.gov, the website of the US National Library of Medicine, National Institutes of Health.

Examined 24-hour duration of action
Evaluated doses of Levemir®
Started Once-Daily
Evaluated A1C Reductions
Weight Outcomes
Evaluated Hypoglycemia
Examined Consistency
Type 2
Blonde et al 2009
(Titrate®) 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 Blonde L, Merilainen M, Karwe V, Raskin P.
Diabetes Obes Metab. 2009;11(6):623-631. 		1
Yenigun et al 2009
(Predictive® European cohort:
switches from insulin glargine
to Levemir® once daily) Switching patients from insulin glargine-based basal-bolus regimens to a once daily insulin detemir-based basal-bolus regimen: results from a subgroup of the Predictive study Yenigun M, Honka M.
Int J Clin Pract. 2009;63(3):425-432. 		2
Raskin et al 2009
(Levemir® + insulin aspart
vs insulin glargine + insulin aspart) Comparison of insulin detemir and insulin glargine using a basal-bolus regimen in a randomized, controlled clinical study in patients with type 2 diabetes Raskin P, Gylvin T, Weng W, Chaykin L.
Diabetes Metab Res Rev. 2009;25(6):542-548. 		3
Hollander et al 2008
(Novel-2: Levemir® vs insulin glargine) 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 (Novel-2) Hollander P, Cooper J, Bregnhøj J, Pedersen CB.
Clin Ther. 2008;30(11):1976-1987. 		4
Rosenstock et al 2008
(Levemir® vs insulin glargine) A randomised, 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 Rosenstock J, Davies M, Home PD, Larsen J, Koenen C, Schernthaner G.
Diabetologia. 2008;51(3):408-416. 		5
Selam et al 2008
(Predictive® 303: insulin-naïve) 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 Selam JL, Koenen C, Weng W, Meneghini L.
Curr Med Res Opin. 2008;24(1):11-20. 		6
Meneghini et al 2007
(Predictive®: German cohort) 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 Meneghini LF, Rosenberg KH, Koenen C, Merilainen MJ, Lüddeke HJ.
Diabetes Obes Metab. 2007;9(3):418-427. 		7
Meneghini et al 2007
(US Predictive® 303: overall population) 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 Meneghini L, Koenen C, Weng W, Selam JL.
Diabetes Obes Metab. 2007;9(6):902-913. 		8
Hermansen et al 2006
(Levemir® vs NPH) A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naïve people with type 2 diabetes Hermansen K, Davies M, Derezinski T, Ravn GM, Clauson P, Home P, on behalf of the Levemir Treat-to-Target Study Group.
Diabetes Care. 2006;29(6):1269-1274. 		9
Philis-Tsimikas et al 2006
(Levemir® vs NPH) Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes Philis-Tsimikas A, Charpentier G, Clauson P, Ravn GM, Roberts VL, Thorsteinsson B.
Clin Ther. 2006;28(10):1569-1581. 		10
Haak et al 2005
(Levemir® + insulin aspart vs NPH + insulin aspart) Lower within-subject variability of fasting blood glucose and reduced weight gain with insulin detemir compared to NPH insulin in patients with type 2 diabetes Haak T, Tiengo A, Draeger E, Suntum M, Waldhäusl W.
Diabetes Obes Metab. 2005;7(1):56-64. 		11
Raslová et al 2004
(Levemir® + insulin aspart vs NPH + RHI) Insulin detemir and insulin aspart: a promising basal-bolus regimen for type 2 diabetes Raslová K, Bogoev M, Raz I, Leth G, Gall M-A, Hâncu N.
Diabetes Res Clin Pract. 2004;66(2):193-201. 		12
Type 1
Yenigun et al 2009
(Predictive® European cohort:
switches from insulin glargine
to Levemir® once daily) Switching patients from insulin glargine-based basal-bolus regimens to a once daily insulin detemir-based basal-bolus regimen: results from a subgroup of the Predictive study Yenigun M, Honka M.
Int J Clin Pract. 2009;63(3):425-432. 		13
Le Floch et al 2009
(Adapt: Levemir® once daily + insulin aspart vs twice daily + insulin aspart) Comparison of once- versus twice-daily administration of insulin detemir, used with mealtime insulin aspart, in basal-bolus therapy for type 1 diabetes: assessment of Detemir Administration in a Progressive Treat-to-Target Trial (Adapt) Le Floch JP, Lévy M, Mosnier-Pudar H, et al.
Diabetes Care. 2009;32(1):32-37. 		14
Dornhorst et al 2008
(Switch from NPH or insulin glargine
to Levemir®: or basal-bolus with
human insulins to Levemir®: + insulin aspart) Safety and efficacy of insulin detemir basal-bolus therapy in type 1 diabetes patients: 14-week data from the European cohort of the Predictive study Dornhorst A, Lüddeke HJ, Honka M, et al.
Curr Med Res Opin. 2008;24(2):369-376. 		15
Hermansen et al 2004
(Levemir® + insulin aspart vs NPH + RHI) Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with type 1 diabetes Hermansen K, Fontaine P, Kukolja KK, Peterkova V, Leth G, Gall M-A.
Diabetologia. 2004;47(4):622-629. 		16
Home et al 2004
(Levemir® + insulin aspart vs NPH + insulin aspart) Insulin detemir offers improved glycemic control compared with NPH insulin in people with type 1 diabetes: a randomized clinical trial Home P, Bartley P, Russell-Jones D, et al.
Diabetes Care. 2004;27(5):1081-1087 		17
Russell-Jones et al 2004
(Levemir® + RHI vs NPH + RHI) Effects of QD insulin detemir or neutral protamine Hagedorn on blood glucose control in patients with type I diabetes mellitus using a basal-bolus regimen Russell-Jones D, Simpson R, Hylleberg B, Draeger E, Bolinder J.
Clin Ther. 2004;26(5):724-736. 		18
Other
King 2009
(CGMS study in patients with T2DM;
Levemir® vs insulin glargine) Once-daily insulin detemir is comparable to once-daily insulin glargine in providing glycaemic control over 24 h in patients with type 2 diabetes: a double-blind, randomized, crossover study King AB.
Diabetes Obes Metab. 2009;11(1):69-71. 		19
Borah et al 2009
(Review of health care claims data
and lab results in patients with T2DM;
Levemir® vs insulin glargine) A comparison of insulin use, glycemic control, and health care costs with insulin detemir and insulin glargine in insulin-naive patients with type 2 diabetes Borah BJ, Darkow T, Bouchard J, Aagren M, Forma F, Alemayehu B.
Clin Ther. 2009;31(3):623-631. 		20
Danne et al 2008
(Clamp study vs insulin glargine
in pediatric patients with T1DM) Insulin detemir is characterized by a more reproducible pharmacokinetic profile than insulin glargine in children and adolescents with type 1 diabetes: results from a randomized, double-blind, controlled trial Danne T, Datz N, Endahl L, et al.
Pediatr Diabetes. 2008;9(6):554-560. 		21
Heise and Pieber 2007
(Review of clamp studies in patients
with T1 or T2DM; Levemir® vs insulin glargine) Towards peakless, reproducible and long-acting insulins: an assessment of the basal analogues based on isoglycaemic clamp studies Heise T, Pieber TR.
Diabetes Obes Metab. 2007;9(5):648-659. 		22
Klein et al 2007
(Clamp study in patients with T2DM) Albumin-bound basal insulin analogues (insulin detemir and NN344): comparable time-action profiles but less variability than insulin glargine in type 2 diabetes Klein O, Lynge J, Endahl L, Damholt B, Nosek L, Heise T.
Diabetes Obes Metab. 2007;9(3):290-299. 		23
Heise et al 2004
(Clamp study vs NPH and insulin glargine
in patients with T1DM) Lower within-subject variability of insulin detemir in comparison to NPH insulin and insulin glargine in people with type 1 diabetes Heise T, Nosek L, Rønn BB, et al.
Diabetes. 2004;53(6):1614-1620. 		24

†5682 patients evaluated in randomized controlled trials.

  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.

  2. NovoLog® (insulin aspart [rDNA origin] injection) Indications and Usage

    NovoLog® is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.

    NovoLog® Important Safety Information

    NovoLog® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog® or one of its excipients.

    NovoLog® has a more rapid onset and shorter duration of action than regular human insulin. An injection of NovoLog® should be immediately followed by a meal within 5 to 10 minutes. Because of the short duration of action of NovoLog®, a longer-acting insulin also should be used in patients with type 1 diabetes and may be needed in patients with type 2 diabetes. When used in an external subcutaneous insulin infusion pump, NovoLog® should not be mixed with any other insulin or diluent. Hypoglycemia is the most common adverse effect of all insulin therapies, including NovoLog®. The timing of hypoglycemia usually reflects the time-action profile of the administered insulins.

    Any change of insulin dose should be made cautiously and only under medical supervision. Glucose monitoring is recommended for all patients with diabetes and is particularly important for patients using external pump infusion therapy. As with all insulin preparations, the time course of action of NovoLog® may vary in different individuals or at different times in the same individual and is dependent on many conditions, including injection site, local blood supply, temperature, and level of physical activity.

    Needles and NovoLog® FlexPen® must not be shared.

    NovoLog® has not been studied in children with type 2 diabetes or in children with type 1 diabetes under the age of two.

    Severe, life-threatening generalized allergy, including anaphylactic reaction, may occur with any insulin product, including NovoLog®. Adverse reactions observed with NovoLog® include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus. Insulin, particularly when given intravenously or in settings of poor glycemic control, may cause hypokalemia. Like all insulins, NovoLog® requirements may be reduced in patients with renal impairment or hepatic impairment.

    All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. This background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy.

    Please see Prescribing InformationPrescribing Information.

Levemir® and NovoLog® are registered trademarks of Novo Nordisk. NovoMedLink™ is a trademark of Novo Nordisk.