Ipragliflozin, a novel, selective inhibitor of sodium-dependent glucose co-transporter 2 (SGLT2), in clinical development for type 2 diabetes mellitus (T2DM) treatment, when added to metformin reduces HbA1c in a dose dependent manner. These findings were discussed by J. Wilding and colleagues at the IDF World Diabetes Congrss Dubai. The study assessed the efficacy and safety of ipragliflozin as add-on therapy to metformin in T2DM patients with inadequate glycemic control on metformin monotherapy.Researchers primarily studied the change in HbA1c from baseline compared to placebo. Additionally they observed the change from baseline FPG and proportion achieving HbA1c target of <7.0% at week 12. Treatment emergent adverse events (TEAEs), including urinary tract infection (UTI), genital tract infection (GTI), hypoglycemia; vital signs and other safety parameters were also assessed.
Findings from the study showed that Ipragliflozin decreased HbA1c in a dose-dependent manner by 0.53–0.79%, compared to 0.31% with placebo (P<0.001).
With the exception of the lowest dose, more ipragliflozin-treated patients had HbA1c below <7% at week 12 compared to placebo .All ipragliflozin groups exhibited a modest decrease in body weight and blood pressure.
TEAEs were observed in 39.7–51.4% of ipragliflozin-treated subjects, versus 39.4% on placebo. UTI and GTI in ipragliflozin groups (4.3 and 1.8%) were similar to the placebo group (6.1 and 1.5%).Hypoglycemia was also similar between placebo (3.1%) and treatment groups (0.0-4.5%) and there were no meaningful effects on other safety parameters