The lower body weight associated with the SGLT2 inhibitor ipragliflozin is the result of fat mass reduction with muscle mass and bone mineral content largely unchanged, according to results of a study of Japanese adults with type 2 diabetes on insulin therapy.
“Body weight gain is a major disadvantage of insulin treatment,” Katsutaro Morino, MD, PhD, of the department of medicine at Shiga University of Medical Science in Japan, and colleagues wrote. “SGLT2 inhibitors improve glycemic control and induce [body weight] reduction by creating a negative energy balance through urinary glucose excretion. ... However, little is currently known about how [body weight] and body composition are affected by SGLT2 inhibitors in the clinical setting.”
Morino and colleagues conducted a randomized, open-label comparative clinical trial with 48 adults with type 2 diabetes (mean age, 60.6 years; 21 women) who were enrolled at Shiga University of Medical Science Hospital in Japan from November 2015 to March 2017. Before enrollment, all participants were receiving insulin treatment and were aged 20 to 75 years with HbA1c levels between 7% and 10% and a BMI of at least 23 kg/m2.
Morino and colleagues randomly assigned participants to two groups at a 1:1 ratio. The treatment group received 50 mg ipragliflozin (Astellas Pharma and Kotobuki Pharmaceutical) after breakfast each day for 24 weeks. Those in the control group did not adjust their pretreatment regimen during the 24 weeks of the trial.
The researchers were primarily interested in the change in total body weight after 24 weeks, but also examined changes in body fat mass, lean body mass and changes in bone mineral content, as well as changes in fat and lean body mass in three areas (arms, trunk and lower limbs).
Participants in the treatment group had an average change in total body weight of –2.78 kg compared with a change of –0.22 kg in the control group for a total body weight loss difference of –2.56 kg between the two groups (95% CI, –3.67 to –1.45) (P <0.0001). In addition, the treatment group had a larger decrease in fat mass (–2.07 kg) compared with controls (–0.01 kg; P < .0001).
The researchers did not find a significant change in bone mineral content or total muscle mass between the groups; absolute change in fat mass in the trunk for participants in the treatment group (–1.31 kg) was greater than in the control group (0.22 kg; P < .0001). Participants in the treatment group also had a greater absolute change in lean mass in the arms (–0.19 kg) compared with the control group (0.02 kg; P < .01). Additionally, the researchers found a much larger percentage change in lean mass (–3.46%) in the arms of participants in the treatment group compared with participants in the control group (0.37%; P < .01). A similar result was found in muscle mass in the arms of participants in the treatment group (–1.81%) vs. the control group (0.62%; P < .05). – by Phil Neuffer
Disclosures: This study was funded by Astellas Pharma. Morino reports that he received grants from AstraZeneca and Ono Pharmaceutics unrelated to this study. Please see the study for all other authors’ relevant financial disclosures.