It's easy to look at the headline for clinical trials and think everything is fine. After all, the drug met its primary endpoint and that's a good thing, right? Sure, but there's often more to the story.
This week's "That's great but ..." moment comes from sanofi-aventis
In the trial released yesterday, Sanofi compares the drug to placebo. That's an OK strategy for diseases where there are no other treatment options, but there are numerous options for pre-insulin diabetics, including Merck's
Until that data is available, we'll have to withhold judgment about how well the drug works. It looks promising that 46.5% to 52.2% of patients on drug reached the target HbA1c level -- a measure of long-term glucose levels -- compared with 26.8% of those taking placebo, but comparing the data to other trials is an exercise in futility. The patient populations are likely to be different, and the procedures can vary, with some drugmakers requiring a wash-out of other drugs while others don't.
Sanofi's bigger problem is that it trails Byetta and Novo Nordisk's
A successful clinical trial makes for a good press release, but it's going to take a lot of luck and perhaps a few stumbles by its competitors for lixisenatide to be successful.
