Comparing the effects of ipragliflozin versus metformin on visceral fat reduction and metabolic dysfunction in Japanese patients with type 2 diabetes treated with sitagliptin: A prospective, multicentre, open‐label, blinded‐endpoint, randomized controlled study (PRIME‐V study)

Abstract

A prospective, multicentre, open‐label, blinded‐endpoint, randomized controlled study was conducted to evaluate the efficacy of treatment with ipragliflozin (sodium‐dependent glucose transporter‐2 inhibitor) versus metformin for visceral fat reduction and glycaemic control among Japanese patients with type 2 diabetes treated with sitagliptin, HbA1c levels of 7%‐10%, and body mass index (BMI) ≥ 22 kg/m2. Patients were randomly assigned (1:1) to receive ipragliflozin 50 mg or metformin 1000‐1500 mg daily. The primary outcome was change in visceral fat area as measured by computed tomography after 24 weeks of therapy. The secondary outcomes were effects on glucose metabolism and lipid metabolism. Mean percentage reduction in visceral fat area was significantly greater in the ipragliflozin group than in the metformin group (−12.06% vs. −3.65%, P = 0.040). Ipragliflozin also significantly reduced BMI, subcutaneous fat area, waist circumference, fasting insulin, and homeostatic model assessment (HOMA)‐resistance, and increased HDL‐cholesterol levels. Metformin significantly reduced HbA1c and LDL‐cholesterol levels and increased HOMA‐beta. There were no severe adverse events. The use of ipragliflozin or metformin in combination with dipeptidyl peptidase‐4 inhibitors, widely used in Japan, may have beneficial effects in ameliorating multiple cardiovascular risk factors.

Hospitalization for heart failure incidence according to the transition in metabolic health and obesity status: a nationwide population-based study

“…In a previous study from a Swedish nationwide registry of obese people, people who underwent gastric bypass surgery lost 18.8 kg more weight after 1 year and 22.6 kg more after 2 years on average and had a lower hazard of incident HF with an HR of 0.54 (95% CI 0.36-0.82) than did people who were managed through lifestyle modification only [45]. Treatment modalities proven to have beneficial effects both on metabolic health and obesity including bariatric surgery [46,47], sodium glucose cotransporter 2 inhibitors [48,49] and glucagon-like polypeptide-1 receptor agonists [50,51] might also be a preventive strategy for incident hHF.…”

Effects of ipragliflozin versus metformin in combination with sitagliptin on bone and muscle in Japanese patients with type 2 diabetes mellitus: Subanalysis of a prospective, randomized, controlled study (PRIME‐V study)

“…A subanalysis was carried out with data obtained during a randomized controlled study, whose design and principal results have already been published 4,12 . The responsible institutional review boards (Appendix ) approved the protocol.…”

“…Previously, we have reported that the SGLT2 inhibitor ipragliflozin reduces visceral fat to a greater extent than metformin when used in combination with the DPP‐4 inhibitor, sitagliptin 4 . Furthermore, according to the results of recent randomized clinical trials, SGLT2 inhibitors could prevent cardiovascular events and heart failure, and also have renal protective effects 5–7 .…”

Comparison of Visceral Fat Reduction by Ipragliflozin and Metformin in Elderly Type 2 Diabetes Patients: Sub-Analysis of a Randomized-Controlled Study

“…Previous studies have shown that the accumulation of visceral fat is significantly associated with metabolic abnormalities [ 4 ]. We had previously conducted a randomized-controlled study [ 5 ] to evaluate the efficacy of ipragliflozin, a novel sodium-glucose transporter 2 (SGLT2) inhibitor, compared with that of metformin, for visceral fat reduction and glycemic control in Japanese patients with T2D being treated with sitagliptin. Our results showed that the mean percentage reduction in visceral fat area was significantly greater in the ipragliflozin group than in the metformin group.…”