Diabetes Drug From Astra, Bristol Shows Benefit In Study
02 October 2009 - 6:48AM
Dow Jones News
Adding an experimental diabetes drug co-developed by AstraZeneca
PLC (AZN) and Bristol-Myers Squibb Co. (BMY) to the drug metformin
reduced a measure of blood sugar versus metformin alone, a new
study found.
A summary of the data for the drug dapagliflozin was posted on
the Website of the annual meeting of the European Association for
the Study of Diabetes; researchers are scheduled to present the
findings in Vienna on Friday.
Some analysts think the drug has potential to be a blockbuster,
but they're closely watching its emerging safety profile because
its novel mechanism raises theoretical safety issues. Unlike other
diabetes drugs that involve insulin, dapagliflozin blocks
reabsorption of blood sugar and causes excretion of the glucose in
urine. While this approach may prove to be effective, it has also
raised the potential for higher risk of infections, which could
limit the drug's market appeal.
"We remain concerned on the side effect profile of dapagliflozin
with higher infection rates and potential impact on both kidney
function and bone metabolism seen in" earlier stage studies,
Jefferies International analyst Jeffrey Holford wrote in a research
note earlier this week. He also noted the relatively short duration
of the new study, saying longer term data will be needed to flesh
out the safety issue.
Still, Holford estimates peak annual sales of $1.5 billion for
the drug, with half being attributable to each company.
Dapagliflozin, known as a sodium glucose co-transporter 2, or
SGLT2, is the second diabetes drug stemming from a partnership
between Bristol and Astra. The first was Onglyza, which was
approved by the U.S. Food and Drug Administration in July.
In the new study, funded by the companies, nearly 550 people
with type 2 diabetes received various dose levels of dapagliflozin,
or placebo, once daily, plus the drug metformin. Eligible patients
had inadequate blood-sugar control on metformin alone. The study
was designed to track at 24 weeks changes in HbA1c, a test that
measures the amount of a substance called glycated hemoglobin,
which is formed in red blood cells when blood sugar attaches to
hemoglobin.
The study found that each of the dose levels of dapagliflozin
produced a greater reduction in HbA1c than metformin alone. The
changes in the dapagliflozin arms ranged from reductions of 0.67%
to 0.84%, versus 0.3% in for metformin alone. In addition, users of
dapagliflozin had greater weight loss than those on metformin
alone.
The study's summary said adverse events were generally balanced
across all groups in the study. Rates of urinary-tract infections
were similar or lower for the dapagliflozin users, versus metformin
alone, but rates of genital infections were higher for
dapagliflozin users. There were no meaningful changes in signs of
kidney impairment.
The researchers concluded that the drug appeared safe and was
associated with significantly improved blood-sugar control and
clinically meaningful weight loss over 24 weeks, versus
placebo.
-Peter Loftus; Dow Jones Newswires; 215-656-8289;
peter.loftus@dowjones.com