Efficacy and Safety of Ipragliflozin in Japanese Patients With Type 2 Diabetes: Interim Outcome of the ASSIGN-K Study

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

Abstract


Background: Ipragliflozin is a sodium-glucose co-transporter 2 inhibitor that can improve glycemic control and reduce body weight and blood pressure in patients with type 2 diabetes mellitus (T2DM). We evaluated the efficacy and safety of ipragliflozin in the real-world clinical setting, with a focus on the changes of body composition up to 3 months of treatment.

Methods: This was a prospective multicenter interventional trial. We investigated changes of the blood pressure, body composition, blood glucose, hemoglobin A1c (HbA1c), ketone bodies, lipids, and insulin after treatment with ipragliflozin (50 - 100 mg/day) for 12 weeks in Japanese patients with T2DM who showed poor glycemic control despite receiving diet and exercise therapy with or without oral antidiabetic drugs for more than 12 weeks.

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: In patients with T2DM, ipragliflozin improved glycemic control after 1 month of treatment and caused weight loss by reducing body fat more than body water.




J Clin Med Res. 2016;8(2):116-125
doi: http://dx.doi.org/10.14740/jocmr2417w

Correction in J Clin Med Res. 2016;8(3):267-267, doi: http://dx.doi.org/10.14740/jocmr2417wc1


Keywords


Body composition; Type 2 diabetes mellitus; Sodium-glucose co-transporter 2 inhibitor; Ipragliflozin; Antidiabetic agent

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