Over 52 weeks, glycemic control was improved and body weight and blood pressure were reduced with Invokana as add-on therapy to metformin in patients with type 2 diabetes, according to a presentation here.
In the randomized, double blind study, Katherine Merton, PhD, of Janssen Scientific Affairs, and colleagues evaluated data from 1,450 adults (mean age, 56.2 years) with type 2 diabetes (mean HbA1c, 7.8%; mean BMI, 31 kg/m2) on background metformin randomly assigned to Invokana (canagliflozin, Janssen) 100 mg or 300 mg or glimepiride for 52 weeks to determine the effects of the treatments on metabolic syndrome components.
Participants were further diagnosed with metabolic syndrome if they met two or more of the following criteria: triglyceride levels of at least 150 mg/dL; HDL cholesterol less than 40 mg/dL for men and less than 50 mg/dL for women; waist circumference at least 102 cm for non-Asian men, at least 88 cm for non-Asian women, greater than 90 cm for Asian men and greater than 80 cm for Asian women; or a diagnosis of hypertension or BP-related criteria (systolic BP 130 mm Hg or diastolic BP 85 mm Hg). At week 52, changes from baseline in HbA1c, fasting plasma glucose, BP, waist circumference, body weight, BMI and lipid levels were evaluated.
Eighty-one percent of participants met the criteria for metabolic syndrome at baseline with the proportions similar across the treatment groups. Overall, 1,160 participants had data available to assess all metabolic syndrome criteria with 39.7% meeting three, 33.7% meeting four and 17.2% meeting five criteria.
At week 52, 1,132 participants with metabolic syndrome at baseline had data available to assess metabolic syndrome criteria; there were fewer participants with metabolic syndrome in the canagliflozin 100 mg (86.7%) and cangliflozin 300 mg (85.8%) groups compared with the glimepiride group (92.7%).
HbA1c reduction was greater with canagliflozin 300 mg (-0.9%) compared with canagliflozin 100 mg and glimepiride, which both reduced HbA1c by 0.8%.
Both canagliflozin doses resulted in reductions in fasting plasma glucose, systolic BP, diastolic BP, waist circumference, body weight and BMI compared with glimepiride.
LDL cholesterol and HDL cholesterol were increased with both doses of canagliflozin compared with glimepiride. Triglyceride reduction was greater with canagliflozin 100 mg compared with glimepiride whereas levels were similar between glimepiride and canagliflozin 300 mg.
“Canagliflozin improved all components of [metabolic syndrome] including glycemic control, BP, and weight loss compared with glimepiride over 52 weeks in patients with type 2 diabetes Merton said. “These findings support the use of canagliflozin versus glimepiride in patients who had type 2 diabetes and metabolic syndrome compnents.” – by Amber Cox