Insulin detemir
Encyclopedia
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 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:
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.
Novo Nordisk
Novo Nordisk manufactures and markets pharmaceutical products and services. Created in 1989 through a merger of two Danish companies dating back to the 1920s, it has become one of the world's leading companies in diabetes care, where Novo Nordisk pursues research into pulmonary delivery systems;...
markets it under the trade name Levemir. It is an insulin analogue in which a fatty acid
Fatty acid
In chemistry, especially biochemistry, a fatty acid is a carboxylic acid with a long unbranched aliphatic tail , which is either saturated or unsaturated. Most naturally occurring fatty acids have a chain of an even number of carbon atoms, from 4 to 28. Fatty acids are usually derived from...
(myristic acid
Myristic acid
Myristic acid, also called tetradecanoic acid, is a common saturated fatty acid with the molecular formula CH312COOH. A myristate is a salt or ester of myristic acid....
) is bound to the lysine
Lysine
Lysine is an α-amino acid with the chemical formula HO2CCH4NH2. It is an essential amino acid, which means that the human body cannot synthesize it. Its codons are AAA and AAG....
amino acid at position B29. It is quickly absorbed after which it binds to albumin
Albumin
Albumin refers generally to any protein that is water soluble, which is moderately soluble in concentrated salt solutions, and experiences heat denaturation. They are commonly found in blood plasma, and are unique to other blood proteins in that they are not glycosylated...
in the blood through its fatty acid at position B29. It then slowly dissociates from this complex.
In a clinical study 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
Hypoglycemia
Hypoglycemia or hypoglycæmia is the medical term for a state produced by a lower than normal level of blood glucose. The term literally means "under-sweet blood"...
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
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.
External links
- Levemir US website
- http://www.levemir-us.com/prescribing_information.pdf Levemir Package Insert