Diabetes GLP-1 Treatment Misses Primary Endpoints

The investigational drug Bydureon used to treat Type 2 diabetes under development by Eli Lilly & Co., Amylin Pharmaceuticals Inc. and Alkermes Inc. failed to meet primary endpoints in a 26-week study....

The study failed to show that Bydureon, a once-a-week diabetes shot, was as effective at lowering blood sugar as Victoza, a once-a-day drug from Novo Nordisk.

Both Bydureon and Victoza are synthetic versions of the glucagon-like peptide-1, or GLP-1, which stimulates the body to use insulin to regulate blood sugar. GLP-1 drugs are appealing because they are less likely than insulin to cause low blood sugar, which can be dangerous. The drugs control blood sugar and may also help patients lose some weight.

Bydureon is a longer-acting version of Byetta, the first GLP-1 drug, which was based on a chemical in Gila monster spit that is similar to GLP-1. Byetta must be given twice a day; Victoza is given once daily, and has been gaining share.

The expectation of the new study was that patients who took the once-weekly Bydureon would control their blood sugar at least as well as those who took once-daily Victoza. That didn’t happen. Patients who took Victoza reduced hemoglobin A1C, a measure of blood sugar, by 1.5 pecentage points, compared to 1.3 percentage points from Bydureon.

Bydureon still has two marketing advantages. One is that it is injected less often. Outside of a clinical trial, patients may be more likely to forget their doses. A second is that Bydureon caused less nausea than Victoza. Twenty percent of patients on Victoza had nausea, 11% had vomiting, and 13% had diarrhea. That compares to a 9% rate of nausea on Bydureon, a 4% rate of vomiting, and a 6% rate of diarrhea.

The GLP-1 space is getting highly competitive. GlaxoSmithKline has its own GLP-1 drug in late-stage trials, and Sanofi-Aventis has one that it plans to pair with its insulin pens. Eli Lilly is also developing another GLP-1 that is distinct from the Amylin products.

Bydureon still faces another hurdle at the FDA, which wants more data on whether it changes heart rhythms. Analysts largely expect that study to work out, although it has resulted in a significant FDA delay.

http://www.diabetesincontrol.com/index.php?option=com_content&view=article&id=10577-diabetes-glp-1-treatment-misses-primary-endpoints&catid=1&Itemid=8

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