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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 )
Author(s) -
Kitazawa Toru,
Seino Hiroaki,
Ohashi Hiroshi,
Inazawa Takeshi,
Inoue Masahiro,
Ai Masumi,
Fujishiro Midori,
Kuroda Hisamoto,
Yamada Masayo,
Anai Motonobu,
Ishihara Hisamitsu
Publication year - 2020
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.14059
Subject(s) - glimepiride , metformin , type 2 diabetes , medicine , endocrinology , uric acid , gastroenterology , diabetes mellitus , pharmacology
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.