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

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.