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Ipragliflozin safe, effective in Japanese adults with overweight, obesity
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Japanese adults with type 2 diabetes and overweight or obesity saw reductions in HbA1c, fasting plasma glucose and body weight across BMI categories after 12 to 24 weeks of ipragliflozin therapy, according to a meta-analysis in the Journal of Diabetes Investigation.
Atsunori Kashiwagi , MD, PhD, of Kusatsu General Hospital in Shiga, Japan, and colleagues analyzed data from five randomized, double blind trials conducted in Japan. Researchers randomly assigned participants ipragliflozin (Astellas Pharma and Kotobuki Pharmaceutical; n = 508) or placebo (n = 321), either as monotherapy or combined with metformin, pioglitazone or a sulfonylurea. Researchers measured changes in HbA1c, fasting plasma glucose, body weight and adverse events. Patients were divided into four BMI categories (< 23 kg/m², 23 kg/m² to < 25 kg/m², 25 kg/m² to < 28 kg/m² and 28 kg/m².
Across all BMI categories and in the total cohort, researchers found that HbA1c decreased for the ipragliflozin group vs. placebo (placebo-adjusted mean change of –1.17%; P < .001). Across studies, 18.3% of patients assigned ipragliflozin achieved the target HbA1c of 7% or less vs. 2.5% of placebo patients. Fasting plasma glucose also decreased for the ipragliflozin group vs. placebo (placebo-adjusted mean change of –41.8 mg/dL; P < .001), as did body weight (–2.2 kg vs. –0.5 kg).
The change in HbA1c was weakly correlated with the change in body weight in all patients (r = 0.136; P = .002), according to researchers.
Reported adverse events were similar between the ipragliflozin and placebo groups in all patients combined and across the four BMI categories, according to researchers; genital infections, urinary tract infections, polyuria and thirst were more common in the ipragliflozin groups.
“Moreover, when we preformed stepwise multiple regression to identify variables associated with the change in HbA1c from baseline to the end of treatment, the final model did not include BMI as an explanatory variable, which suggests that baseline BMI was not associated with the change in HbA1c,” the researchers wrote. – by Regina Schaffer
Disclosure: Kashiwagi reports consulting for and receiving honoraria from Astellas Pharma; the other researchers are employees of Astellas Pharma. Astellas Pharma sponsored this study and contributed to the study design, writing of the report and the decision to submit the paper for publication.
Perspective
Back to TopTsuyoshi Okura, MD, PhD
SGLT-2 inhibitors reduce HbA1c, fasting plasma glucose and body weight. In general, it is believed that these agents are effective for obese patients with type 2 diabetes. However, half of Japanese patients with type 2 diabetes are not obese subjects. Therefore, we are interested in the efficacy of SGLT-2 inhibitors and the relationship between glycemic control and body weight in Japanese patients with type 2 diabetes. This study showed that the efficacy and safety of ipragliflozin are not influenced by obesity/overweight in Japanese patients. Although this study did not analyze the lean subjects, for example, a BMI of less than 20 kg/m², ipragliflozin was effective for the participants with a BMI of 23 kg/m² or less. I think we must pay attention to the safety of the lean subjects in the long period; however, these findings are helpful for our daily clinical work.
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