Dapagliflozin Doesn't Increase Dietary Intake in Japanese

Abstract

Purpose: We randomly allocate to dapagliflozin (DAPA) administered group (group A) and the group continuing current treatment (group B) for type 2 diabetic patients with stable glycemic control and investigate whether changes in eating behavior are observed or not. Method: group A orally administer 5 mg of DAPA once daily for 12 weeks in addition to current diet therapy · exercise therapy and diabetes drugs. In the group B, the current diet therapy/exercise therapy and diabetes drugs are continued for 12 weeks. Blood test and urinalysis were conducted 0 weeks, 4 weeks, 12 weeks after. The main endpoint was the comparison between the two groups of total calorie intake change using brief-type self-administered diet history questionnaire (BDHQ) at 12 weeks. And the secondary endpoints were comparison between two groups of the following items before and after treatment. 1.) nutritional status based on BDHQ, 2.) body weight, abdominal girth, blood pressure, grip strength, 3.) blood glucose profile, 4.) lipid profile. Subject: There were 76 cases of consent to participation in this study, but since there were three dropout cases, the analysis subjects were 35 patients in group A, 38 patients in group B. Result: In the group A, HbA1c (7.47±0.67 vs. 7.09±0.56 p<0.0001) and body weight (70.20±11.79 vs. 69.15±12.13 p<0.0002) decreased significantly, but no change in total caloric intake by BDHQ (1675.23±580.67 vs. 1636.92±625.32) was observed. On the other hand, in the group B, no changes in total calorie intake by BDHQ, HbA1c, body weight, were observed. Discussion: This study indicated that no increase in dietary intake was observed upon weight loss by DAPA. It has already been reported that weight loss due to DAPA improves patients’ QoL. Improvement of this QoL may be expected to have a positive influence on improvement of treatment motivation and diet therapy/exercise therapy which is the basis of diabetes treatment. This study suggests that in humans, unlike animal experiments, calorie loss by DAPA may have a positive effect on dietary behavior. Disclosure M. Kitaoka: Research Support; Self; AbbVie Inc., AstraZeneca, Ono Pharmaceutical Co., Ltd.. H. Fujii: None. K. Imai: None. Y. Echida: None. K. Kanno: Research Support; Self; Astellas Pharma Inc.. Speaker's Bureau; Self; Novo Nordisk Inc., Sanofi K.K., MSD K.K.. Research Support; Self; Taisho Toyama Pharmaceutical Co., Ltd.. Speaker's Bureau; Self; Mitsubishi Tanabe Pharma Corporation, Takeda Phamaceutical Company Ltd. T. Miyakawa: Speaker's Bureau; Self; Novo Nordisk A/S, Eli Lilly and Company, MSD K.K.. M. Shigeta: None.