Effect of empagliflozin monotherapy on postprandial glucose and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, 4-week study

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• 作者：Rimei Nishimura ; Yuko Tanaka ; Kazuki Koiwai ; Kohei Inoue…
• 关键词：SGLT2 inhibitor ; Continuous glucose monitoring ; CGM
• 刊名：Cardiovascular Diabetology
• 出版年：2015
• 出版时间：December 2015
• 年：2015
• 卷：14
• 期：1
• 全文大小：1,187 KB
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• 刊物主题：Diabetes; Angiology; Cardiology;
• 出版者：BioMed Central
• ISSN：1475-2840

文摘

Background This study evaluated the effect of empagliflozin on postprandial glucose (PPG) and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus (T2DM). Methods Patients (N--0; baseline mean [SD] HbA1c 7.91 [0.80]%; body mass index 24.3 [3.2] kg/m2) were randomized to receive empagliflozin 10?mg (n--0), empagliflozin 25?mg (n--9) or placebo (n--1) once daily as monotherapy for 28?days. A meal tolerance test and continuous glucose monitoring (CGM) for 24?hours were performed at baseline and on days 1 and 28. The primary endpoint was change from baseline in area under the glucose concentration-time curve 3?hours after breakfast (AUC1-h for PPG) at day 28. Results Adjusted mean (95%) differences versus placebo in changes from baseline in AUC1-4h for PPG at day 1 were ?7.1 (?26.5, ?7.8) mg?·?h/dl with empagliflozin 10?mg and ?1.6 (?20.4, ?2.8) mg?·?h/dl with empagliflozin 25?mg (both p--.001 versus placebo) and at day 28 were ?5.5 (?26.0, ?5.0) mg?·?h/dl with empagliflozin 10?mg and ?04.9 (?44.8, ?5.0) mg?·?h/dl with empagliflozin 25?mg (both p--.001 versus placebo). Adjusted mean (95% CI) differences versus placebo in change from baseline in 24-hour mean glucose (CGM) at day 1 were ?0.8 (?7.0, ?4.7) mg/dl with empagliflozin 10?mg and ?3.9 (?0.0, ?7.9) mg/dl with empagliflozin 25?mg (both p--.001 versus placebo) and at day 28 were ?4.5 (?5.4, ?3.6) mg/dl with empagliflozin 10?mg and ?1.7 (?2.5,-20.9) mg/dl with empagliflozin 25?mg (both p--.001 versus placebo). Changes from baseline in mean amplitude of glucose excursions (MAGE; CGM) were not significantly different with either empagliflozin dose versus placebo at either timepoint. Curves of mean glucose (CGM) did not change between baseline and day 1 or 28 with placebo, but shifted downward with empagliflozin. Percentage of time with glucose ?0 to Conclusion Empagliflozin for 28?days reduced PPG from the first day and improved daily blood glucose control in Japanese patients with T2DM. Trial registration Clinicaltrials.gov NCT01947855