May 18, 2014
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Canagliflozin alone lowers HbA1c and body weight in type 2 diabetes

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LAS VEGAS — Canagliflozin, used as a monotherapy, lowered HbA1c and body weight in a majority of patients at 26 weeks, according to a presenter at the AACE 23rd Annual Scientific & Clinical Congress.

Perspective from Alan J. Garber, MD, PhD

In patients with type 2 diabetes inadequately controlled by diet and exercise, canagliflozin 100 and 300 mg provided significant dose-dependent reductions in HbA1c and body weight compared with placebo,” William Canovatchel, MD, said during his presentation. “These findings suggest that patients treated with cangliflozin are more likely to obtain individual and composite diabetes-related quality measures and this may impact selection of therapeutics for type 2 management as physicians try to individualize their therapy for their patients.”

In this 26-week, randomized, double-blind, placebo-controlled, phase 3 study conducted in 17 countries, patients with inadequately controlled type 2 diabetes  (n=584; mean age, 55.4 years; HbA1c, 8.0%; body weight, 86.8 kg; BMI, 31.6 kg/m2) received canagliflozin 100 or 300 mg or placebo once a day.

At week 26, researchers observed significant reductions in HbA1c (–0.77%, –1.03%, and 0.14%) and body weight (–2.5 kg, –3.4 kg and –0.5 kg) with canagliflozin 100 mg and 300 mg, as compared with placebo, respectively. A greater proportion of patients treated with either dose of canagliflozin compared with placebo lowered both HbA1c and body weight (70.7%, 84%, and 27.5%, respectively).

“More than 70% of patients treated with the canagliflozin 100 mg had a reduction in both their HbA1c and bodyweight, compared to 28% of the patients in the placebo group,” Canovatchel said. “More than 80% of the patients treated with the 300 mg dose of canagliflozin had a reduction in both HbA1c and body weight, compared to the 28% of those treated with placebo.”

Overall, canagliflozin was well tolerated. It was associated with an increased trend toward genital mycotic infections, urinary tract infections, and osmotic diuresis-related adverse events compared with placebo and had a low incidence of hypoglycemia.

Canovatchel said there was a 26-week extension trial, totaling 52 weeks of data, and while that data is being analyzed, he speculated that body weight was well maintained.

For more information: Canovatchel W. Abstract #1314. Presented at: AACE 23rd Annual Scientific & Clinical Congress; May 13-18, 2014; Las Vegas, Nevada.

Disclosures: Canovatchel is an employee of Janssen Research & Development, LLC, and this study was supported by Janssen.