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My life depends entirely on getting little squirts of insulin into my bloodstream on a regular basis. Too little, and high blood glucose hijacks my moods—tired and cranky are the watchwords here. Too much insulin makes my BGs plummet—and shakiness and confusion take over until I eat something containing sugar.
Since injected insulin first became available to diabetics in 1922, its manufacturers have been reformulating their product to make it work better in our bodies. We need insulin that acts quickly, and we need insulin that lasts a long time.
At one time there were over a dozen long-acting insulins to choose from, but they have been steadily removed from the market to make way for newer products.
Recently two of our long-acting insulin options—UltraLente and Lente—were taken off the market. This left us with just one long-acting insulin: Lantus. Many diabetics were frustrated to lose their favorite long-acting insulins and to be left with only one, with no other choices. So it is with much interest that we announce the launch of a new long-acting insulin. Now once again, we have a choice.
On March 28, 2006, Novo Nordisk announced that its long-acting insulin Levemir is now commercially available in the United States, giving Lantus a run for its money.
We interviewed Peter Aurup, MD, vice president of clinical development, medical and regulatory affairs for Novo Nordisk, to learn more about this new insulin.
Look for more about Levemir in our June 2006 issue.
In trials that have been conducted thus far, has Levemir been shown to be longer- or shorter-acting than Lantus?
What we have demonstrated and what is on the label is that Levemir has consistently shown a 24-hour duration of action, so I think that addresses your question. It’s clearly long acting with BG control lasting up to 24 hours.
How has Levemir stacked up against Lantus in any head-to-head studies?
In studies, we achieved glycemic control that was comparable to [Lantus] based on A1C, and this was in patients with both types 1 and 2.
Many people who take Lantus really need to take it twice day. Will that be the case with Levemir? What is Novo Nordisk’s dosage recommendation?
Clearly, we want the healthcare professional and patient to individualize treatment. We recommend that you initiate therapy with Levemir once a day preferably in the evening at a dose of, for example, 10 units. Then you base your subsequent titration on your glycemic response.
Who is the ideal candidate for Levemir?
Anybody who takes insulin. Anyone who, based on their total assessment, would benefit from a long-acting basal insulin.
Are there any adverse reaction warnings for Levemir that are different from other insulins?
When you look at safety, we have been achieving, compared to Lantus, the same safety profile. However, compared to NPH and human insulin, across all of the studies, we saw a very low incidence of hypoglycemia and less weight gain. [Levemir] matches up very easily with Lantus.
We ran a story recently in which a few experts in the diabetes community raised concerns about long-term use of Lantus. Their concerns stemmed from some studies done several years ago that found Lantus was more likely to stimulate IGF-1 receptors than was human insulin. Circulating IGF-1 has been associated with certain types of cancers. Have your studies found any link between Levemir usage and stimulation of IGF-1?
We have done the mandatory mitogenicity and carcinogenicity studies, and in all cases have seen a low incidence of any kinds of abnormalities than have been observed with human insulin. In fact, we have studied more than 130 times the expected maximum human dose of Levemir and have not seen anything that exceeds what has been seen with human insulin. In terms of the IGF-1, I fully share your concerns, and it has been very nice to see preclinical data [finding] that the effect of the IGF-1 is multiples lower for Levemir than for human insulin. That was in both in-vitro studies and animal studies.
Type 1, 31 years (and counting)
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0 comments - May 1, 2006
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