Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes receiving conventional therapy: clinical implication of the importance of exercise habits during treatment with ipragliflozin

Abstract

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 therapyrelated 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).

A Review of the Effects of Glucagon-Like Peptide-1 Receptor Agonists and Sodium-Glucose Cotransporter 2 Inhibitors on Lean Body Mass in Humans

“…Details of all eligible studies identified in our search can be found in Tables 2,3,4 [242526272829303132333435363738394041424344454647484950515253545556575859606162636465666768]. The following paragraphs provide an overview of the findings for each individual therapy within both drug classes.…”

“…Of the seven studies identified for ipragliflozin, six reported that the contribution of LBM/FFM to total weight loss elicited ranged from 22% to 49% [525354555759]. All of these studies were in individuals with T2DM, and included two studies using DXA, reporting 22% and 49% of 2.8 and 3.5 kg of weight loss over 24 weeks, respectively.…”

The Impact of Glucose-Lowering Drugs on Sarcopenia in Type 2 Diabetes: Current Evidence and Underlying Mechanisms

“…Similarly, a significant reduction in SMM (-0.6 kg) following ipragliflozin treatment (50 mg/daily) for 12 weeks was observed in a small trial [84]. In contrast, Miyake et al find a not significant reduction in SMM (−2.2%) after 24 weeks of treatment with ipragliflozin (50 mg/daily) in patients with T2DM and NAFLD [85].…”

Effect of Orally Administered Semaglutide Versus Dulaglutide on Diabetes-Related Quality of Life in Japanese Patients with Type 2 Diabetes: The PIONEER 10 Randomized, Active-Controlled Trial

“…The DTR-QoL is a Japanese-specific measure of HRQoL that has been extensively employed in studies of glucose-lowering medication, including several involving GLP-1RAs [ 33 – 35 ], dipeptidyl peptidase-4 inhibitors [ 36 – 38 ], and the SGLT2i ipragliflozin [ 39 ]. As in the current trial, the questionnaire has shown a high sensitivity for detecting and measuring diabetes-related HRQoL compared with, for example, the EQ-5D questionnaire [ 40 ].…”