Efficacy and Safety of Ipragliflozin in Japanese Patients With Type 2 Diabetes: Interim Outcome of the ASSIGN-K Study.
Abstract | BACKGROUND: METHODS: RESULTS: Two hundred and fifty-seven subjects were included in the efficacy analysis up to 12 weeks of treatment and 301 subjects were included in the safety analysis. From baseline to 12 weeks, HbA1c showed a change of -0.68% (95% confidence interval (CI): -0.83, -0.53) and fasting blood glucose showed a change of -23.9 mg/dL (95% CI: -30.5, -17.2), with both parameters displaying a significant reduction (P < 0.001). The difference of body weight from baseline was -1.82 kg (95% CI: -2.14, -1.50), and it also showed significant reduction (P < 0.001). Analysis of body composition revealed that body fat changed by -1.46 kg (95% CI: -1.79, -1.14, P < 0.001) and body water changed by -0.37 kg (95% CI: -0.60, -0.14, P < 0.01). Laboratory tests demonstrated improvement of liver function and the lipid profile. Adverse events (AEs) occurred in 22.6% of the subjects, with frequent events being vulvovaginal candidiasis in 2.7% and cystitis in 2.0%. Serious AEs occurred in three subjects. CONCLUSIONS:
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Authors | Takashi Iizuka, Kotaro Iemitsu, Masahiro Takihata, Masahiko Takai, Shigeru Nakajima, Nobuaki Minami, Shinichi Umezawa, Akira Kanamori, Hiroshi Takeda, Takehiro Kawata, Shogo Ito, Taisuke Kikuchi, Hikaru Amemiya, Mizuki Kaneshiro, Atsuko Mokubo, Tetsuo Takuma, Hideo Machimura, Keiji Tanaka, Taro Asakura, Akira Kubota, Sachio Aoyagi, Kazuhiko Hoshino, Masashi Ishikawa, Yoko Matsuzawa, Mitsuo Obana, Nobuo Sasai, Hideaki Kaneshige, Fuyuki Minagawa, Tatsuya Saito, Kazuaki Shinoda, Masaaki Miyakawa, Yasushi Tanaka, Yasuo Terauchi, Ikuro Matsuba |
Journal | Journal of clinical medicine research
(J Clin Med Res)
Vol. 8
Issue 2
Pg. 116-25
(Feb 2016)
ISSN: 1918-3003 [Print] Canada |
PMID | 26767080
(Publication Type: Journal Article)
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