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Insulin Detemir

Significant Advance or Me Too?

By David Mendosa

Last Update: June 23, 2005

Quite soon we will have another very long-acting insulin. Right now it is called insulin detemir, but when it comes to market it will have a brand name.

No weight gain on detemir.

Novo Nordisk A/S, the Danish pharmaceutical giant, submitted insulin detemir to the Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) in the fourth quarter of 2002. In October 2003 the FDA issued its tentative approval in a so-called “approvable letter.” The letter requests that Novo Nordisk address certain clinical issues and provide additional information before the FDA will grant U.S. marketing approval.

When I first wrote about insulin detemir in the November 1998 issue Diabetes Wellness Letter, it was entering clinical trials and Novo was calling its insulin NN304. It is typical for a new drug to change its name twice. For example, I wrote about the first very long-acting insulin, Lantus, in the same article. Its original name was HOE901, because Hoechst Marion Roussel developed it. Then it became known as insulin glargine before it got the Lantus brand name.

Lantus has been a phenomenal success for Aventis S.A., which was created in December 1999 by the merger of the life sciences activities of Hoechst AG and Rhône-Poulenc S.A. It works so well as a basal insulin that, according to David Kliff, the publisher of Diabetic Investor newsletter, it is eating into the insulin pump market.

Insulin detemir is quite similar to Lantus, so comparisons with it are inevitable. Both are insulin analogs, which researchers produce through genetic engineering. They are both true basal, or depot, insulins because they can remain active for a full 24 hours with essentially no peaks or valleys.

Does this mean insulin detemir is merely a ho-hum copycat drug? I don’t think so, because it may have some unique advantages.

Some studies reported no weight gain among participants in clinicail trials of insulin detemir. That is not just unusual. It is unheard of for people on insulin.

Novo also says that Lantus produces variable blood glucose responses to the same dose given on different days. The distinct chemical structure of insulin detemir, however, allows for a slower and more stable absorption from the injection site.

One disadvantage of Lantus is that it can’t be mixed with other insulins. It is still uncertain whether insulin detemir can be mixed with rapid-acting insulin analogs. If possible, that would decrease the number of injections required.

All this makes insulin detemir seem promising indeed. Now all it needs is final FDA approval and a sexier name. 


This article originally appeared on mendosa.com, November 20, 2003.


Update

Detemir now has both a sexier name, Levemir, and — even more important — FDA approval on June 17, 2005. Previously 37 countries, including the European Union member states, had approved Levemir. Novo Nordisk hopes to make Levemir available in the U.S. sometime this year.

At this time, the Novo Nordisk website doesn’t have any information about Levemir for those of us who are only people with diabetes. But if you “solemnly declare” that you are a healthcare professional, you can read more on their Levemir page.


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