| Clinical data | |
|---|---|
| AHFS/Drugs.com | monograph |
| MedlinePlus | a606012 |
| Pregnancy cat. | C(US) |
| Legal status | ℞-only (US) |
| Routes | Subcutaneous |
| Pharmacokinetic data | |
| Bioavailability | 60% (when administered s.c.) |
| Half-life | 5–7 hours |
| Identifiers | |
| CAS number | 169148-63-4 |
| ATC code | A10AE05 |
| DrugBank | DB01307 |
| UNII | 4FT78T86XV |
| KEGG | D04539 |
| Chemical data | |
| Formula | C267H402N64O76S6 |
| Mol. mass | 5913 |
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Insulin detemir is a long-acting human insulin analogue for maintaining the basal level of insulin. Novo Nordisk markets it under the trade name Levemir. It is an insulin analogue in which a fatty acid (myristic acid) is bound to the lysine amino acid at position B29. It is quickly absorbed after which it binds to albumin in the blood through its fatty acid at position B29. It then slowly dissociates from this complex.
In a clinical study[1] that compared the efficacy and safety of using Levemir for the treatment of patients with type 2 diabetes who had suboptimal glycemic control while receiving maximally tolerated doses of metformin and sulfonylurea (common tablet therapies for type 2 diabetes), it was found that, "At 24 weeks, A1C (glycosylated hemoglobin) had decreased by 1.8 and 1.9% (from 8.6 to 6.8 and from 8.5 to 6.6%) for detemir and NPH, respectively (NS). In both groups, 70% of participants achieved an A1C of 7.0%, but the proportion achieving this without hypoglycemia was higher with insulin detemir than with NPH insulin (26 vs. 16%, P = 0.008). Compared with NPH insulin, the risk for all hypoglycemia with insulin detemir was reduced by 47% (P < 0.001) and nocturnal hypoglycemia by 55% (P < 0.001). Mean weight gain was 1.2 kg with insulin detemir and 2.8 kg with NPH insulin (P < 0.001), and the difference in baseline-adjusted final weight was –1.58 (P < 0.001)."
In short, it was found that insulin detemir reduced Hemoglobin A1C to target levels of 7.0% for 70% of patients, similar to human basal insulin NPH, but without the same risk of hypoglycemia and with somewhat less weight gain.
Regarding weight gain compared to NPH insulin, the The Levemir package insert states the following disclaimer:
"LEVEMIR was associated with somewhat less weight gain than NPH (Table 4). Whether these observed differences represent true differences in the effects of LEVEMIR and NPH insulin 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..."Levemir Package Insert; Adverse Reactions > Weight Gain
In addition, the safety and efficacy of insulin detemir (Levemir®) in real life clinical practice was evaluated in the A1chieve study.
On June 13, 2009, the U.S. Food and Drug Administration (FDA) issued a public health advisory for Levemir insulin after learning that 129,000 stolen vials reappeared and were being sold in the U.S. market. The FDA warned that the stolen vials "may not have been stored and handled properly and may be dangerous for patients to use." The stolen vials were identified as lots XZF0036, XZF0037, and XZF0038.
1. http://content.nejm.org/cgi/content/full/NEJMoa075392, Addition of Biphasic, Prandial, or Basal Insulin to Oral Therapy in Type 2 Diabetes; Rury R. Holman, M.B., Ch.B., F.R.C.P., Kerensa I. Thorne, M.Sc., Andrew J. Farmer, D.M., F.R.C.G.P., Melanie J. Davies, M.D., F.R.C.P., Joanne F. Keenan, B.A., Sanjoy Paul, Ph.D., Jonathan C. Levy, M.D., F.R.C.P., for the 4-T Study Group
2. http://www.springerlink.com/content/6lktug1r2exurq0j/?p=af5e2f613a0f4c6690f8fdc920f48bd6&pi=5 , 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, Journal Diabetologia, volume 47, number 4 / April, 2004.
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