June 26, 2010 / 6:48 PM / 9 years ago

New J&J diabetes drug effective in mid-stage study

* Blood glucose reduction seen at all canagliflozin doses

* Weight loss of 2.3-3.4 percent seen with J&J drug

* Recruitment for large Phase III program under way

* Sees filing for U.S. approval in 2012

By Bill Berkrot

NEW YORK, June 26 (Reuters) - An experimental Johnson & Johnson (JNJ.N) diabetes drug led to improved blood sugar control and weight loss when used in combination with metformin, according to data from a mid-stage study.

Statistically significant reductions in levels of A1C, a commonly used blood sugar measure, were seen at all tested doses of J&J’s canagliflozin compared with a placebo in the 12-week, 451-patient study, researchers said.

Canagliflozin belongs to a new class of oral Type 2 diabetes treatments called selective sodium-glucose transporter-2 (SGLT2) inhibitors. It is believed that blocking SGLT2 significantly increases the amount of glucose excreted in the urine that would otherwise be reabsorbed into the blood after passing through the kidneys.

“Our study suggests that inhibiting SGLT2 with canagliflozin in combination with metformin could potentially offer a good alternative for treating patients with Type 2 diabetes who are not reaching their goals with metformin alone,” Dr Julio Rosenstock, who presented the data on Saturday at the American Diabetes Association scientific meeting in Orlando, said in a statement.

J&J said it is recruiting for Phase III clinical trials that it expects to involve more than 10,000 patients with Type 2 diabetes, including a lengthy study to demonstrate that canagliflozin does not increase heart attack or stroke risk.

The company plans to file its application seeking U.S. approval in 2012, Kirk Ways, J&J’s vice president of clinical development for canagliflozin, said in a telephone interview.

All patients in the Phase II study were already taking metformin, typically one of the first medicines doctors reach for in treating Type 2 diabetes. Patients who fail to achieve target blood sugar levels on metformin are usually given an additional drug from a different class of diabetes treatments.

The study tested canagliflozin once daily at 50 milligrams, 100 mg, 200 mg and 300 mg, as well as 300 mg given twice daily. There was also a placebo arm of the study and another group that received Merck & Co’s (MRK.N) Januvia, which belongs to a class known as DPP-4 inhibitors, as an active reference arm.

Patients who received the two lowest doses of the J&J drug saw A1C levels drop by an average of 0.8 percent, while the 200 mg dose led to a drop of 0.7 percent. Both groups that received the 300 mg regimens had A1C fall by 0.9 percent, researchers said. Januvia, known chemically as sitagliptin, led to an A1C reduction of 0.7 percent, while placebo patients experienced a decrease of only 0.2 percent.

The company cautioned that the trial was not designed to compare the efficacy of canagliflozin with Januvia.

Between 50 percent and 70 percent of patients who took canagliflozin at doses of 100 mg or higher achieved ADA target A1C levels of 7 percent or lower compared with 35 percent in the placebo group, Way said.

The company is moving forward with the 100 mg and 300 mg once daily doses in its Phase III studies.

Patients who took canagliflozin also experienced weight loss of 2.3 percent to 3.4 percent, researchers said. Januvia led to weight loss of 0.6 percent, which was less than the 1.1 percent weight loss seen in the placebo group.

Weight loss is an especially attractive effect in diabetes treatments as obesity is a leading cause of Type 2 diabetes and some older medicines cause weight gain.

Incidence of hypoglycemia, or potentially dangerously low blood sugar levels, was low and similar in the canagliflozin and placebo arms, researchers said.

Similarly small incidence of serious adverse events — one in each canagliflozin group — and discontinuations due to adverse events were observed across all treatment arms, they said. There was an increase in mild to moderate vaginal yeast infections seen with women taking canagliflozin, researchers said.

“We’re very excited about this drug, with the A1C lowering, low risk of hypoglycemia, weight loss, and ability to add it across the spectrum of the disease (from early to late stages) and to other agents,” J&J’s Way said.

“We think this class and this specific molecule are really going to bring an important new profile to the market to add to the care of patients with diabetes,” he added. (Reporting by Bill Berkrot; Editing by Steve Orlofsky)

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