By Jennifer Corbett Dooren
WASHINGTON--Data from advanced clinical studies of a new type of
diabetes drug being developed by a unit of Johnson & Johnson
(JNJ) showed it reduced a measure of blood sugar in patients with
type 2 diabetes.
The drug, canagliflozin, was studied in nine so-called Phase 3
studies, which are needed to support regulatory approval of
products.
Information from five of the studies will be presented this
weekend at the American Diabetes Association's annual meeting and
will provide the first in-depth look at the drug. So far the U.S.
Food and Drug Administration has refused to approve a similar drug,
dapagliflozin, from Bristol-Myers Squibb Co. (BMY) and AstraZeneca
PLC (AZN) and has asked the companies for more information to
assess risks and benefits.
Broadly the canagliflozin studies show the drug was better than
or similar to other diabetes drugs at reducing blood sugar. Overall
side-effect rates were similar among patient groups.
Janssen Research and Development LLC, part of J&J, submitted
an application with the FDA seeking approval of canagliflozin on
May 31. It is the first time Johnson & Johnson has sought FDA
approval of a diabetes drug. Other J&J units sell diabetes
devices like blood-glucose meters.
"We studied the drug in a broad range of patients," said Kirk
Ways, vice president and compound development leader for
canagliflozin. "We feel the benefit-risk profile is good."
Canagliflozin is in a new class of drugs called sodium-glucose
co-transporter-2 (SGLT2) inhibitors. Such drugs are designed to
lower blood glucose levels in patients with diabetes by increasing
the amount of glucose excreted in the urine. The SGLT2 system is
used by the kidneys to filter and reabsorb glucose circulating in
the blood.
Dr. Ways explained that currently available diabetes treatments
work in different ways to lower blood sugar, so canagliflozin could
potentially be added to those drugs. Diabetes is a progressive
disease that usually requires treatment with different types of
drugs.
One of the canagliflozin studies involved patients whose blood
sugar was inadequately controlled on metformin, typically the first
drug given to treat type 2 diabetes. The study compared two doses
of canagliflozin to patients being given glimepiride, a drug often
used once metformin stops working.
The main study goal was to look at changes in A1C blood
hemoglobin levels, a common measurement of blood glucose. The 1,450
patients in the study had an average A1C of 7.8% at the study's
start. After one year, the study showed the 100 milligram dose of
canagliflozin was similar to patients being treated with
glimepiride by reducing blood sugar levels to an average of 7%. The
higher, 300 milligram dose of canagliflozin reduced average blood
sugar levels by nearly a full percentage point.
People without diabetes typically have an A1C level below 6%.
Diabetes treatments are aimed at reducing blood sugar levels to 7%
or below.
The other study involved 755 people who didn't have good
blood-sugar control on metformin and a sulfonylurea drug, such as
glimepiride. Patients had an average A1C of 8.1% at study start.
Patients were treated with the highest, 300 milligram dose of
canagliflozin or sitagliptin, sold as Januvia by Merck & Co.
(MRK). Januvia is a newer diabetes medication that works in a
different way than metformin and sulfonylurea drugs. After one year
the study showed patients on canagliflozin had drops in blood sugar
levels of a full percentage point while those in the Januvia group
had a decline of 0.66%.
However, both studies showed patients receiving canagliflozin
had a higher rate of genital infections and reports of more
frequent urination than patients in comparison groups. Dr. Ways
said the infections were effectively treated with topical or oral
anti-fungal medications and said most patients did not stop taking
canagliflozin.
Diabetes affects about 26 million Americans and is characterized
by high blood glucose levels caused by the body's inability to
either make or properly use insulin. Type 2 diabetes is the most
common form of the disease and is often associated with weight gain
and older age. Type 1 is an autoimmune disease often diagnosed in
children in which the body's immune system destroys pancreatic beta
cells that produce insulin.
Write to Jennifer Corbett Dooren at
jennifer.corbett@dowjones.com