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Liraglutide: New Long-Acting Release Injectable in Development for Diabetes

by  David Mendosa
Tuesday, June 27, 2006

Byetta and the long-acting release (LAR) formulation of that diabetes medication got most of the attention at the 66th Scientific Sessions of the American Diabetes Association just concluded in Washington.

But two related drugs had a coming out party there. All of these drugs are analogs of GLP-1 (glucagon-like peptide-1). The oral presentations I heard and the posters I saw about one of them impressed me.

Until the ADA convention I had heard almost nothing about any other GLP-1 analog except for Byetta and its long-acting release cousin. But at the convention I heard a lot about liraglutide, which the Danish company Novo Nordisk now has in Phase 3 clinical trials.

The two oral presentations and the three posters about liraglutide convinced me that it will be as important for people with type 2 diabetes when it becomes available as Byetta is now. In just 14 weeks people at the highest dose in one clinical trial, reported in 115-OR , ended up with an A1C level 1.74 percent less than those taking a placebo. In the same time they lost an average of 6.6 pounds.

Like Byetta, some of those taking liraglutide had gastrointestinal side effects. But they didn’t last.

Also like Byetta, liraglutide lowers blood glucose only when levels are too high. So hypos are unlikely.

Unlike Byetta, which requires two injections a day because of its half-life of 2 to 4 hours, liraglutide requires only one daily shot, because it has a much longer half-life, 11 to 15 hours. It gets that longer duration because it binds with albumin.

Novo Nordisk had originally named liraglutide as NN2211. The company hasn’t announced its proposed brand name yet.

I reported on earlier trials of NN2211 in a 2002 issue of my “Diabetes Update” newsletter. That article also mentioned the other company that presented a GLP-1 analog in the recent ADA convention, ConjuChem Inc., which has its headquarters in Montreal, Canada.

ConjuChem calls its drug CJC-1134 and PC-DAC Exendin-4. The mice, rats, and monkeys they tested with it had lower A1Cs and weight, as reported in 362-OR and 434-P.

ConjuChem has been testing its drug as a once-a-week injection. But a company press release says that Phase 1/2 clinical trials show that its half-life is even longer than expected so that “an even longer dosing interval may be possible.”

Not everyone working on a GLP-1 analog made it to the ADA’s party in Washington. Zealand Pharma, based in Copenhagen, Denmark, developed a GLP-1 analog they called ZP10. Sanofi-aventis, headquartered in Paris, licensed ZP10 and calls it AVE0010.

A Phase 2 trial of AVE0010 won’t be finished until next March. When it finally has a coming out party, the relatives will include Byetta – the only GLP-1analog that we can use yet – the LAR or long-acting release version of Byetta, Novo Nordisk’s liraglutide, and ConjuChem’s PC-DAC.

That will be a quite a party for type of drug that was unheard of a few years ago. And that will give people with type 2 diabetes some wonderful choices.

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