A new study published in the journal Diabetes, Obesity and Metabolism examines the long-term safety and efficacy of canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor indicated for the treatment of type 2 diabetes.
In this Phase 3 study, the use of canagliflozin was evaluated in type 2 diabetes patients aged 55–80 years over a 104-week treatment period. Patients received either canagliflozin 100 or 300mg or placebo once daily; efficacy endpoints included change from baseline in HbA1c, fasting plasma glucose, and systolic blood pressure (BP). Percent change from baseline in fasting plasma lipids and body weight was also investigated. Adverse event reports were used to assess the safety of treatment.
Compared to placebo, canagliflozin at both 100 and 300mg doses was associated with HbA1c reductions (canagliflozin 100mg: –0.32%; canagliflozin 300mg: –0.43%; placebo: 0.17%), with more patients achieving HbA1c <7.0% in the canagliflozin groups than those given placebo (canagliflozin 100mg: 35.8%; canagliflozin 300mg: 41.9%; placebo: 20.3%). Also, patients in the canagliflozin groups saw reductions in fasting plasma glucose, systolic BP, and body weight and increases in HDL-C and LDL-C versus placebo.
Although the number of serious adverse events for both treatment groups was low, the rates of UTI, genital mycotic infections and osmotic diuresis and adverse events related to volume depletion were higher in the canagliflozin groups than with placebo.
Based on these study results, the authors conclude that the SGLT2 inhibitor canagliflozin can improve glycemic control and reduce systolic BP and body weight and is well-tolerated in this patient population.