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.
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