AIMS: To evaluate the efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes mellitus and inadequate glycemic control and investigate the impact of maintaining exercise habits during treatment. MATERIALS AND METHODS: A total of 20 patients were enrolled. Patients aged 20-70 years with type 2 diabetes mellitus were administered 50 mg of ipragliflozin once daily for 12 weeks. The primary endpoint was the change in glycated hemoglobin levels from baseline to week 12. Key secondary endpoints included changes in total body weight, body composition, serum lipid levels, and diabetes therapy-related quality of life from baseline to week 12. Adverse events were recorded throughout the study. RESULTS: The patients' glycated hemoglobin levels were 0.69% lower at week 12 versus baseline (adjusted mean difference from baseline; P < 0.01, n = 18). Mean total body weight, body composition, and serum lipid levels also improved significantly from baseline. Of note, stratification analysis by physical activity level revealed slight but significant reductions in skeletal muscle mass and muscle mass, but not body fat mass, in the minimal exercise group compared to the data for the moderate exercise group. One of the subdomain structures in diabetes therapy-related quality of life questionnaire, "Anxiety and dissatisfaction with treatment," was significantly improved. Although no major hypoglycemic episodes occurred, two adverse events were reported. CONCLUSIONS: Daily treatment with ipragliflozin was associated with marked improvements in glycemic control and body composition without major side effects, and this improvement was affected by exercise habits. This study was registered with UMIN CTR (no. UMIN000014388).
AIMS: To evaluate the efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes mellitus and inadequate glycemic control and investigate the impact of maintaining exercise habits during treatment. MATERIALS AND METHODS: A total of 20 patients were enrolled. Patients aged 20-70 years with type 2 diabetes mellitus were administered 50 mg of ipragliflozin once daily for 12 weeks. The primary endpoint was the change in glycated hemoglobin levels from baseline to week 12. Key secondary endpoints included changes in total body weight, body composition, serum lipid levels, and diabetes therapy-related quality of life from baseline to week 12. Adverse events were recorded throughout the study. RESULTS: The patients' glycated hemoglobin levels were 0.69% lower at week 12 versus baseline (adjusted mean difference from baseline; P < 0.01, n = 18). Mean total body weight, body composition, and serum lipid levels also improved significantly from baseline. Of note, stratification analysis by physical activity level revealed slight but significant reductions in skeletal muscle mass and muscle mass, but not body fat mass, in the minimal exercise group compared to the data for the moderate exercise group. One of the subdomain structures in diabetes therapy-related quality of life questionnaire, "Anxiety and dissatisfaction with treatment," was significantly improved. Although no major hypoglycemic episodes occurred, two adverse events were reported. CONCLUSIONS: Daily treatment with ipragliflozin was associated with marked improvements in glycemic control and body composition without major side effects, and this improvement was affected by exercise habits. This study was registered with UMIN CTR (no. UMIN000014388).
Authors: Stephan A Veltkamp; Takeshi Kadokura; Walter J J Krauwinkel; Ronald A Smulders Journal: Clin Drug Investig Date: 2011-12-01 Impact factor: 2.859
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