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Efficacy and Safety of Canagliflozin Versus Glimepiride in Patients With Type 2 Diabetes Inadequately Controlled With Metformin (CANTATA-SU): 52 Week Results From a Randomized, Double-Blind, Phase 3 Non-Inferiority Trial
Study Questions:
What are the safety and efficacy of canagliflozin (an inhibitor of the sodium-glucose cotransporter 2, which lowers the renal threshold for glucose) compared with glimepiride as add-on therapy in patients with type 2 diabetes mellitus inadequately controlled with metformin?
Methods:
CANTATA-SU (CANagliflozin Treatment and Trial Analysis versus SULphonylurea) was a randomized, double-blind, active-controlled, international, multicenter phase 3 noninferiority trial. Eligible participants had type 2 diabetes mellitus and glycated hemoglobin (HbA1c) levels of 7.0-9.5% and were receiving stable metformin therapy. Following a placebo run-in period, participants were randomly assigned in a 1:1:1 ratio to canagliflozin 100 mg or 300 mg or glimepiride (starting dose of 1 mg to a maximum dose of 6 mg or 8 mg). The prespecified primary efficacy endpoint was the change in HbA1c from baseline to week 52.
Results:
1,450 of 1,452 randomized patients received at least one dose of medication. A total of 1,161 (80%) completed 52 weeks of treatment with similar rates of discontinuation between groups. For lowering HbA1c at 52 weeks, canagliflozin 100 mg was noninferior to glimepiride and canagliflozin 300 mg was superior to glimepiride (least-squares mean difference -0.12% [95% confidence interval, -0.22 to -0.02]). Proportions of patients achieving HbA1c <7.0% or <6.5% at week 52 were similar between groups. Both canagliflozin doses significantly reduced body weight at week 52 (although changes plateaued at week 26), whereas there was a slight increase with glimepiride (p < 0.0001 for both doses of canagliflozin vs. glimepiride). Overall frequency of adverse events was similar between groups. There were increased rates of genital myocotic infections, urinary tract infections, and osmotic diuresis-related adverse events with canagliflozin compared with glimepiride.
Conclusions:
Following 1 year of therapy, both canagliflozin 100 mg and 300 mg once daily were noninferior to glimepiride for reduction of HbA1c and were well tolerated in patients receiving background metformin therapy.
Perspective:
This analysis establishes the safety and efficacy of canagliflozin. Although associated with complications presumably related to glucosuria (i.e., genital myocotic infections and urinary tract infections), canagliflozin led to reductions in HbA1c and decrease in body weight. Canagliflozin may be a viable treatment option for patients with inadequate glycemic control on metformin monotherapy.
Keywords: Sulfonylurea Compounds, Glycosuria, Urinary Tract Infections, Biomarkers, Blood Glucose, Cardiology, Body Weight, Diuresis, Glucosides, Diabetes Mellitus, Glucose
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