Ipragliflozin Improves Glycemic Control and Decreases Body Fat in Patients With Type 2 Diabetes Mellitus.

Abstract

BACKGROUND:

Ipragliflozin, a sodium-glucose transporter 2 inhibitor, was administered to patients with type 2 diabetes mellitus for 24 weeks to evaluate its effect on glycemic control and body composition.

METHODS:

This was an investigator-initiated multicenter prospective intervention study in which ipragliflozin (50 mg) was administered once daily and glycemic control, blood pressure, body weight (BW), body composition (measured by a biological impedance method), the lipid profile, and adverse events were evaluated after 4, 12, and 24 weeks of treatment.

RESULTS:

Efficacy and safety up to 24 weeks of ipragliflozin therapy were analyzed in 367 patients and 451 patients, respectively. Hemoglobin A1c decreased significantly from 8.07% at the start of ipragliflozin therapy to 7.26% in week 24 (P < 0.001). Fasting and postprandial blood glucose levels were significantly reduced by ipragliflozin. In week 24, there were significant decreases from baseline in BW (-2.6 kg), waist circumference (-2.9 cm), and body fat mass (-1.9 kg) (P < 0.001). The body water mass and mineral mass were decreased significantly by 0.5 and by 0.1 kg, respectively (P < 0.001), whereas the protein mass did not change significantly. Intracellular water mass did not change significantly, whereas extracellular water mass showed a significant decrease of 0.5 kg (P < 0.001). Muscle mass did not change in the upper and lower limbs, but that of the trunk decreased significantly (P < 0.001). There was a significant decrease in the fasting triglyceride level and a significant increase in fasting high-density lipoprotein cholesterol level, while low-density lipoprotein cholesterol was unchanged. Adverse events occurred in 23.5% of the patients, with a high frequency of genital infections, such as vulvovaginal candidiasis (3.1%) and genital pruritus (1.8%). Adverse drug reactions were noted in 13.7% of the patients.

CONCLUSIONS:

Administration of ipragliflozin for 24 weeks improved glycemic control and decreased BW. Reduction of body fat accounted for more than 70% of the total weight loss and reduction of extracellular water accounted for about 20%.

• Authors: Takehiro Kawata, Takashi Iizuka, Kotaro Iemitsu, Masahiro Takihata, Masahiko Takai, Shigeru Nakajima, Nobuaki Minami, Shinichi Umezawa, Akira Kanamori, Hiroshi Takeda, Shogo Ito, Taisuke Kikuchi, Hikaru Amemiya, Mizuki Kaneshiro, Atsuko Mokubo, Tetsuo Takuma, Hideo Machimura, Keiji Tanaka, Taro Asakura, Akira Kubota, Sachio Aoyanagi, 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. 9 Issue 7 Pg. 586-595 (Jul 2017) ISSN: 1918-3003 [Print] Canada
• PMID: 28611859 (Publication Type: Journal Article)