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.
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.
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DOI：
10.1111/dom.12848
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发表时间：
2017-05
期刊：
影响因子：
--
通讯作者：
Seino Y
中科院分区：
文献类型：
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作者：
Yabe D;Iwasaki M;Kuwata H;Haraguchi T;Hamamoto Y;Kurose T;Sumita K;Yamazato H;Kanada S;Seino Y
本研究调查了日本 2 型糖尿病 (T2D) 患者中不同碳水化合物摄入量下钠-葡萄糖协同转运蛋白 2 (SGLT2) 抑制剂 luseogliflozin 的安全性和有效性。参与者被随机分配到 14 天的 3 种碳水化合物调整膳食（第 1-14 天；高碳水化合物 [HC；55% 总能量碳水化合物] 和高血糖指数 [HGI] 膳食；HC [55% 总能量碳水化合物] 和低血糖指数 [LGI] 膳食；或低碳水化合物 [LC；40% 总能量碳水化合物] 和 HGI 膳食）。所有参与者在过去 7 天（第 8-14 天）接受卢塞格列净治疗，在卢塞格列净治疗前后（第 5-8 天和第 12-15 天）进行连续血糖监测（CGM），并在第 1、8 和 15 天进行血液检查。卢塞格列净显着降低了所有 3 组中曲线下面积和 CGM 值的平均值。所有时间点的空腹血糖、胰岛素和胰高血糖素均相似。与 HC-HGI 和 HC-LGI 组相比，LC-HGI 组第 15 天的酮体显着更高。总之，当膳食含有 40% 至 55% 总能量碳水化合物时，卢塞奥格列净对日本 T2D 患者具有相似的疗效和安全性，但应避免对此类药物进行严格的 LC 饮食，以预防 SGLT2 抑制剂相关的糖尿病酮症酸中毒。
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.