Masaya Koshizaka1,2, Ko Ishikawa3,4, Ryoichi Ishibashi4,5, Sho Takahashi6, Kenichi Sakamoto4, Hidetaka Yokoh3,4, Yusuke Baba3,4, Shintaro Ide3,4, Kana Ide3,4, Takahiro Ishikawa4,7, Shunichiro Onishi8,9, Kazuki Kobayashi4,8, Minoru Takemoto4,9, Takuro Horikoshi10, Ryota Shimofusa11, Yoshiro Maezawa3,4, Koutaro Yokote3,4. 1. Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan. overslope@chiba-u.jp. 2. Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8670, Japan. overslope@chiba-u.jp. 3. Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan. 4. Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8670, Japan. 5. Department of Medicine, Division of Diabetes,Endocrinology and Metabolism, Kimitsu Chuo Hospital, 1010 Sakurai, Kisarazu City, Chiba, 292-8535, Japan. 6. Clinical Research Support Center, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan. 7. Geriatric Medical Center, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan. 8. Department of Diabetes and Metabolism, Asahi General Hospital, 1326 I, Asahi City, Chiba, 289-2511, Japan. 9. Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, International University of Health and Welfare, 4-3 Kozunomori, Narita City, Chiba, 286-0048, Japan. 10. Diagnostic Radiology and Radiation Oncology, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8670, Japan. 11. Department of Radiology, Sannou Hospital, 166-2 Sannou-chou, Inage-ku, Chiba City, Chiba, 263-0002, Japan.
Abstract
INTRODUCTION: To compare the effects of ipragliflozin, a sodium-glucose transporter 2 inhibitor, with those of metformin on visceral fat (as well as muscles and bones) in Japanese elderly patients with type 2 diabetes (T2D), we conducted a sub-analysis of a prospective, multicenter, blinded-endpoint randomized-controlled study. METHODS: In total, 103 patients with T2D (body mass index≥ 22 kg/m2; glycated hemoglobin, 7-10%) and being treated with sitagliptin (a dipeptidyl peptidase-4 inhibitor) were included and randomized to receive ipragliflozin or metformin. The primary outcome was the change in visceral fat area measured using computed tomography 24 weeks following treatment. The secondary outcomes included changes in subcutaneous and total fat area, muscle volume, bone density measured using computed tomography, handgrip strength, bone markers, plasma glucose, insulin, homeostasis model assessment (HOMA)2-beta, HOMA2-R, glycated hemoglobin, lipid panel, uric acid, blood pressure, adiponectin, and high-sensitivity C-reactive protein. All patients aged 65-74 years were selected for sub-analysis. RESULTS: The sub-analysis included 15 and 14 patients in the ipragliflozin and metformin groups, respectively. The patients' backgrounds were well balanced. Visceral fat area reduction was greater in the ipragliflozin group than in the metformin group (- 10.58% vs. - 6.93%; P = 0.034). There were significant differences in the changes in bone absorption markers, uric acid, and total cholesterol levels between the groups. CONCLUSION:Ipragliflozin significantly reduced the visceral fat area compared with metformin when added to sitagliptin in elderly patients with T2D. Long-term and large-scale studies are required to elucidate whether ipragliflozin is suitable for elderly patients. TRIAL REGISTRATION: The study was registered at https://www.umin.ac.jp/ctr/ (UMIN-ID: UMIN 000015170).
RCT Entities:
INTRODUCTION: To compare the effects of ipragliflozin, a sodium-glucose transporter 2 inhibitor, with those of metformin on visceral fat (as well as muscles and bones) in Japanese elderly patients with type 2 diabetes (T2D), we conducted a sub-analysis of a prospective, multicenter, blinded-endpoint randomized-controlled study. METHODS: In total, 103 patients with T2D (body mass index ≥ 22 kg/m2; glycated hemoglobin, 7-10%) and being treated with sitagliptin (a dipeptidyl peptidase-4 inhibitor) were included and randomized to receive ipragliflozin or metformin. The primary outcome was the change in visceral fat area measured using computed tomography 24 weeks following treatment. The secondary outcomes included changes in subcutaneous and total fat area, muscle volume, bone density measured using computed tomography, handgrip strength, bone markers, plasma glucose, insulin, homeostasis model assessment (HOMA)2-beta, HOMA2-R, glycated hemoglobin, lipid panel, uric acid, blood pressure, adiponectin, and high-sensitivity C-reactive protein. All patients aged 65-74 years were selected for sub-analysis. RESULTS: The sub-analysis included 15 and 14 patients in the ipragliflozin and metformin groups, respectively. The patients' backgrounds were well balanced. Visceral fat area reduction was greater in the ipragliflozin group than in the metformin group (- 10.58% vs. - 6.93%; P = 0.034). There were significant differences in the changes in bone absorption markers, uric acid, and total cholesterol levels between the groups. CONCLUSION:Ipragliflozin significantly reduced the visceral fat area compared with metformin when added to sitagliptin in elderly patients with T2D. Long-term and large-scale studies are required to elucidate whether ipragliflozin is suitable for elderly patients. TRIAL REGISTRATION: The study was registered at https://www.umin.ac.jp/ctr/ (UMIN-ID: UMIN 000015170).
Authors: Shamila T De Silva; Madunil A Niriella; Dileepa S Ediriweera; Dulani Kottahachchi; Anuradhani Kasturiratne; Arjuna P de Silva; Anuradha S Dassanayaka; Arunasalam Pathmeswaran; Rajitha Wickramasinghe; N Kato; H Janaka de Silva Journal: Diabetol Metab Syndr Date: 2019-08-14 Impact factor: 3.320