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Comparison of tofogliflozin versus glimepiride as the third oral agent added to metformin plus a dipeptidyl peptidase-4 inhibitor in Japanese patients with type 2 diabetes: A randomized, 24-week,open-label,controlled trial (STOP-OB) |
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| Authors: | Toru Kitazawa MD Hiroaki Seino MD Hiroshi Ohashi MD Takeshi Inazawa MD Masahiro Inoue MD Masumi Ai MD Midori Fujishiro MD Hisamoto Kuroda MD Masayo Yamada MD Motonobu Anai MD Hisamitsu Ishihara MD |
| Affiliation: | 1. Division of Diabetes, Endocrinology and Metabolism, Department of Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan;2. Seino Internal Medicine Clinic, Koriyama, Japan;3. Internal Medicine, Oyama East Clinic, Oyama, Japan;4. Department of Endocrinology and Metabolism, Kashiwa City Hospital, Kashiwa, Japan;5. Sasazuka Inoue Clinic, Tokyo, Japan;6. Tanaka Clinic, Wako, Japan Department of Insured Medical Care Management, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan;7. Division of Diabetes and Metabolism, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan Department of Internal Medicine, Nihon University Hospital, Tokyo, Japan;8. Green Clinic, Mibu, Japan;9. Division of Metabolism and Endocrinology, Department of Internal Medicine, Yokohama Sakae Kyosai Hospital, Yokohama, Japan;10. Research Center for Advanced Science and Technology, The University of Tokyo, Tokyo, Japan Division of Diabetes and Metabolism, The Institute for Adult Diseases, Asahi Life Foundation, Tokyo, Japan;11. Division of Diabetes and Metabolism, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan |
| Abstract: | Metformin plus a dipeptidyl peptidase-4 inhibitor (DPP-4i) is the most common therapy for Japanese patients with type 2 diabetes. This 24-week, multicentre, open-label, parallel-group trial randomized patients on dual therapy to add-on tofogliflozin (20 mg/day, n = 33) or glimepiride (0.5 mg/day, n = 31). The primary outcome was change in body fat percentage. The secondary outcomes included changes in HbA1c, fat mass, fat-free mass, liver function variables and uric acid. Tofogliflozin and glimepiride reduced HbA1c to a similar extent. Body fat percentage did not change from baseline in either group. Fat mass was reduced by tofogliflozin but was increased by glimepiride (by −2.0 ± 1.7 kg and +1.6 ± 1.6 kg, P = .002). Fat-free mass was also reduced by tofogliflozin and increased by glimepiride (by −1.3 ± 1.3 kg and +0.9 ± 2.0 kg, P < .001). Alanine aminotransferase and uric acid levels were reduced by tofogliflozin (P = .006 and P < .001, respectively). These data provide novel information useful for selecting the third oral agent for patients whose diabetes is inadequately controlled with metformin plus DPP-4i dual therapy. |
| Keywords: | body composition clinical trial DPP-4 inhibitor SGLT2 inhibitor sulphonylureas type 2 diabetes |