Patients with type 2 diabetes and mild renal impairment experienced improved glycemic control when treated with ipragliflozin…
According to lead author Atsunori Kashiwagi, MD, PhD, of Kusatsu General Hospital in Shiga, among patients with mild renal impairment, patients receiving ipragliflozin had a mean decrease in HbA1c of 0.56% at 6 months, compared with a change of 0.26% among those given placebo.
But no difference in reduction in HbA1c was seen among patients with moderate renal impairment, with patients receiving the active treatment having a decrease of 0.28% and those given placebo declining by 0.09%, for an adjusted mean difference of 0.17%.
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Ipragliflozin is an oral SGLT2 inhibitor approved in Japan for the treatment of type 2 diabetes that acts by blocking glucose reuptake in the kidney. Because of its mechanism of action, there is some concern that the efficacy and safety of ipragliflozin might be compromised in patients with renal impairment.
Therefore, they conducted a randomized multicenter study in adults with diabetes and mild (estimated glomerular filtration rate between 60 and 90 mL/min/1.73 m2) or moderate (30 to 60 mL/min/1.73 m2) renal impairment.
During the 6-month blinded phase of the study, patients received 50 mg of ipragliflozin or placebo each day. They also followed their routine diet and exercise plan and continued on any oral hypoglycemic regimen. After week 24, all patients received the active treatment for an additional 28 weeks.
In the first phase, 118 patients were assigned to the ipragliflozin group and 46 to the placebo group. At 24 weeks, the mean change in HbA1c in the active treatment group was -0.42% compared with -0.17% in the placebo group, for an adjusted mean difference of -0.25% (P=0.004).
The mean change in body weight in the ipragliflozin group was -1.87 kg compared with -0.06 kg in the placebo group.
Change in body weight was significantly greater in the ipragliflozin group than the placebo group for patients with both mild and moderate renal impairment, the researchers found.
But as with HbA1c, the decrease in fasting plasma glucose was significantly greater in the ipragliflozin group only among patients with mild renal impairment, at -16.2 mg/dL compared with -3.2 mg/dL, No difference was seen for those with moderate renal impairment.
Among patients with mild renal impairment, serious adverse events were reported in 8.2% of patients on ipragliflozin and 4.3% of those on placebo, while for moderate impairment, the rates were 5.2% and 4.3%.
- At 24 weeks, the mean change in HbA1c in the active treatment group was -0.42% compared with -0.17% in the placebo group.
- Estimated glomerular filtration rate decreased in the active treatment group in the first few weeks but returned to baseline by the end of the first phase of the study.
- The investigational SGLT2-selective inhibitor found to be safe for those with mild renal impairment.
Kashiwagi A, et al “A randomized, double blind, placebo-controlled study on long-term efficacy and safety of ipragliflozin treatment in patients with type 2 diabetes mellitus and renal impairment: results of the LANTERN study (Long-term ASP1941 safety evaluation in T2DM patients with renal impairment.” Diab Obesity Metab 2014; DOI: 10.1111.dom.12403.