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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) |
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| Authors: | Masaya Koshizaka MD Ko Ishikawa MD Ryoichi Ishibashi MD Yoshiro Maezawa MD Kenichi Sakamoto MD Daigaku Uchida MD Susumu Nakamura MD Masaya Yamaga MD Hidetaka Yokoh MD Akina Kobayashi MD Shunichiro Onishi MD Kazuki Kobayashi MD Jun Ogino MD Naotake Hashimoto MD Hirotake Tokuyama MD Fumio Shimada MD Emi Ohara MD Takahiro Ishikawa MD Mayumi Shoji MD Shintaro Ide MD Kana Ide MD Yusuke Baba MD Akiko Hattori MD Takumi Kitamoto MD Takuro Horikoshi MD Ryota Shimofusa MD Sho Takahashi PhD Kengo Nagashima PhD Yasunori Sato PhD Minoru Takemoto MD Laura Kristin Newby MD Koutaro Yokote MD On Behalf of the PRIME-V Study Group |
| Affiliation: | 1. Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, Chiba, Japan;2. Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, Chiba, Japan;3. Department of Internal Medicine, Hotaruno Central Naika, Chiba, Japan;4. Department of Internal Medicine, Odayama Clinic, Chiba, Japan;5. Department of Diabetes and Metabolism, Japanese Red Cross Narita Hospital, Chiba, Japan;6. Department of Diabetes and Metabolism, Asahi General Hospital, Chiba, Japan;7. Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, Chiba, Japan Department of Diabetes and Metabolism, Asahi General Hospital, Chiba, Japan;8. Department of Diabetes, Endocrine and Metabolic Diseases, Tokyo Women's Medical University Yachiyo Medical Center, Chiba, Japan;9. Department of Internal Medicine, Yukarigaoka Tokuyama Medical Clinic, Chiba, Japan;10. Department of Diabetes and Metabolism, National Hospital Organization Chiba Medical Center, Chiba, Japan;11. Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan Geriatric Medical Center, Chiba University Hospital, Chiba, Japan;12. Diagnostic Radiology and Radiation Oncology, Chiba University Graduate School of Medicine, Chiba, Japan;13. Department of Radiology, Sannou Hospital, Chiba, Japan;14. Clinical Research Center, Chiba University Hospital, Chiba, Japan;15. Department of Global Clinical Research, Chiba University, Graduate School of Medicine, Chiba, Japan;16. Department of Diabetes, Metabolism and Endocrinology, School of Medicine, International University of Health and Welfare, Chiba, Japan;17. Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina;18. Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan |
| 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. |
| Keywords: | insulin sensitivity ipragliflozin metformin sitagliptin visceral fat |