title: Sodium-glucose co-transporter-2 inhibitor use and dietary carbohydrate intake in Japanese individuals with type 2 diabetes: A randomized, open-label, 3-arm parallel comparative, exploratory study.
abstract: This study investigated the safety and efficacy of the sodium-glucose co-transporter-2 (SGLT2) inhibitor luseogliflozin with differing carbohydrate intakes in Japanese individuals with type 2 diabetes (T2D). Participants were randomly assigned to 3 carbohydrate-adjusted meals for 14 days (days 1-14; a high carbohydrate [HC; 55% total energy carbohydrate] and high glycaemic index [HGI] meal; an HC [55% total energy carbohydrate] and low glycaemic index [LGI] meal; or a low carbohydrate [LC; 40% total energy carbohydrate] and HGI meal). All participants received luseogliflozin for the last 7 days (days 8-14), continuous glucose monitoring (CGM) before and after luseogliflozin treatment (days 5-8 and days 12-15) and blood tests on days 1, 8 and 15. Luseogliflozin significantly decreased the area under the curve and mean of CGM values in all 3 groups similarly. Fasting plasma glucose, insulin and glucagon were similar at all time points. Ketone bodies on day 15 were significantly higher in the LC-HGI group compared with the HC-HGI and HC-LGI groups. In conclusion, luseogliflozin has similar efficacy and safety in Japanese people with T2D when meals contain 40% to 55% total energy carbohydrate, but a strict LC diet on this class of drug should be avoided to prevent SGLT2 inhibitor-associated diabetic ketoacidosis.
authors.affiliation: Yutaka Seino Distinguished Centre for Diabetes Research, Kansai Electric Power Medical Research Institute, Kobe, Japan.|Centre for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital, Osaka, Japan.|Centre for Metabolism and Clinical Nutrition, Kansai Electric Power Hospital, Osaka, Japan.|Division of Molecular and Metabolic Medicine, Department of Physiology and Cell Biology, Kobe University Graduate School of Medicine, Kobe, Japan.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Yabe
authors.affiliation: Yutaka Seino Distinguished Centre for Diabetes Research, Kansai Electric Power Medical Research Institute, Kobe, Japan.|Centre for Metabolism and Clinical Nutrition, Kansai Electric Power Hospital, Osaka, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Iwasaki
authors.affiliation: Yutaka Seino Distinguished Centre for Diabetes Research, Kansai Electric Power Medical Research Institute, Kobe, Japan.|Centre for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital, Osaka, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Kuwata
authors.affiliation: Centre for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital, Osaka, Japan.
authors.forename: Takuya
authors.initials: T
authors.lastname: Haraguchi
authors.affiliation: Yutaka Seino Distinguished Centre for Diabetes Research, Kansai Electric Power Medical Research Institute, Kobe, Japan.|Centre for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital, Osaka, Japan.|Centre for Metabolism and Clinical Nutrition, Kansai Electric Power Hospital, Osaka, Japan.
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Hamamoto
authors.affiliation: Yutaka Seino Distinguished Centre for Diabetes Research, Kansai Electric Power Medical Research Institute, Kobe, Japan.|Centre for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital, Osaka, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kurose
authors.affiliation: Medical Corporation Heishinkai OCROM Clinic, Osaka, Japan.
authors.forename: Kiminobu
authors.initials: K
authors.lastname: Sumita
authors.affiliation: Medical Corporation Heishinkai OCROM Clinic, Osaka, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Yamazato
authors.affiliation: Medical Corporation Heishinkai OCROM Clinic, Osaka, Japan.
authors.forename: Shigeto
authors.initials: S
authors.lastname: Kanada
authors.affiliation: Yutaka Seino Distinguished Centre for Diabetes Research, Kansai Electric Power Medical Research Institute, Kobe, Japan.|Centre for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital, Osaka, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Seino
mesh_terms: D001786:Blood Glucose / Q000032:analysis; D003131:Combined Modality Therapy; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000178:diet therapy / Q000188:drug therapy* / Q000378:metabolism; D016883:Diabetic Ketoacidosis / Q000209:etiology / Q000517:prevention & control; D050528:Diet, Carbohydrate-Restricted / Q000009:adverse effects; D003927:Diet, Diabetic / Q000379:methods*; D004040:Dietary Carbohydrates / Q000008:administration & dosage* / Q000378:metabolism; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D038321:Glycemic Index; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control; D007003:Hypoglycemia / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan; D007657:Ketone Bodies / Q000097:blood; D008297:Male; D049990:Membrane Transport Modulators / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D008991:Monitoring, Physiologic; D051297:Sodium-Glucose Transporter 2 / Q000378:metabolism; D000077203:Sodium-Glucose Transporter 2 Inhibitors; D013012:Sorbitol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D001786:Blood Glucose; D004040:Dietary Carbohydrates; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007657:Ketone Bodies; D049990:Membrane Transport Modulators; D051297:Sodium-Glucose Transporter 2; D000077203:Sodium-Glucose Transporter 2 Inhibitors; D013012:Sorbitol; C517652:hemoglobin A1c protein, human; C549343:1,5-anhydro-1-(5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl)-1-thioglucitol
keywords: 
  SGLT2 inhibitor; carbohydrate intake; continuous glucose monitoring; glucose variability; glycaemic index; luseogliflozin; type 2 diabetes