Drug & Device Development

Weekly exenatide tops insulin glargine: study

NEW YORK (Reuters June 21) - The once-weekly diabetes drug exenatide, being developed by Eli Lilly and Co and Amylin Pharmaceuticals Inc, was slightly better at controlling blood sugar than insulin glargine (Lantus), with weight loss instead of gain, according to data from a study.

U.S. health regulators are expected to decide by Oct. 22 whether to approve the drug under the proposed brand name Bydureon.

Lilly and Amylin have conducted a series of late-stage trials comparing exenatide with other commonly used Type 2 diabetes treatments -- both oral and injectable.

In the latest 26-week, 456-patient study, exenatide was compared with Lantus. Both drugs significantly improved patients' blood sugar control as measured by levels of hemoglobin A1C, with the key difference being impact on patients' weight, according to data to be presented on Saturday at the American Diabetes Association (ADA) scientific meeting in Orlando and published online today in The Lancet.

There was a higher rate of patient dropouts due to adverse side effects with the exenatide, researchers said. That could be a potential red flag for regulators.

Exenatide belongs to the glucagon-like peptide-1 agonist class of diabetes treatments that stimulate insulin production in order to regulate blood sugar levels.

Patients received either 2 mg of exenatide once a week or daily Lantus injections, on top of the oral treatments of metformin or metformin and sulphonylurea that they were already taking.

Weekly exenatide led to an average drop of 1.5% in A1C levels, compared with a 1.3% reduction for Lantus.

Patients began the study with a mean A1C level of 8.3%, while ADA guidelines call for target levels of 7% or less.

The clinical importance of the modest 0.2% difference between the two drugs is uncertain, researchers said. But exenatide patients on average lost 2.6 kg (5.7 lb) after 26 weeks, while those taking Lantus on average gained 1.4 kg (3.1 lb).

A total of 12 (5%) of exenatide patients discontinued participation in the study because of adverse events, compared with two patients, or 1%, in the Lantus group, researchers said.

Rates of hypoglycemia were lower with exenatide, they said.

There was a small but significant increase in mean heart rate with exenatide, but researchers said the clinical significance was unclear. They intend to keep the study going for two and a half years in order to monitor long-term outcomes of the treatment strategy.

"Diabetes treatments that lower A1C substantially, promote weight loss, and provide convenient dosing without the need for dose titration could improve adherence to treatment and lessen the burden of hyperglycemia," Professor Michaela Diamant, the study's lead investigator from the Diabetes Centre, VU University Medical Centre in Amsterdam, said in the Lancet article.

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)60406-0/abstract

Lancet 2010 June 21

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