Add-on ipragliflozin safe, effective for type 1 diabetes in the long run
Ipragliflozin, as an add-on therapy to insulin, appears to have good long-term efficacy in type 1 diabetes mellitus patients, reports a new Japan study.
Researchers conducted a 28-week, open-label, uncontrolled extension study of a previous phase III trial. Fifty-three patients initially on placebo were switched to once-daily 50-mg ipragliflozin, joining 108 patients who were already on the medication. The primary endpoint was a change in the concentration of glycated haemoglobin (HbA1c), while secondary endpoints included changes in body weight and insulin dose.
Mean HbA1c levels showed substantial decreases by week 4 in patients who were initially on ipragliflozin medication. For those who were switched into the drug from placebo, this effect was apparent at week 28. HbA1c reductions were stable, remaining until week 52.
Overall, the mean change in HbA1c from baseline to end of treatment was –0.33 percent, generally consistent across different patient subgroups.
Twenty-four patients who were switched from placebo, as well as 44 of those who were given ipragliflozin from the start, needed dose increases to 100 mg. These patients had higher baseline HbA1c (9.13 percent vs 8.41 percent), with the uptitrations resulting in decreased HbA1c.
In terms of secondary outcomes, ipragliflozin likewise triggered a drop in basal daily insulin doses and mean body weight, both of which were maintained until the end of treatment.
All patients in both groups showed treatment-emergent adverse events (TEAEs), most of which were deemed related to the drug. However, only 3.7 percent (n=2) and 1.7 percent (n=2) of these events in the patients switched to and initiated on ipragliflozin, respectively, were serious. There were no serious, drug-related TEAEs, nor were there discontinuations or deaths.