Influence of Dapagliflozin on Glycemic Variations in Patients with Newly Diagnosed Type 2 Diabetes Mellitus

Abstract

Objectives . To observe changes in blood glycemic variations and oxidative stress level before and after dapagliflozin treatment in patients with newly diagnosed T2DM. Methods . This was a randomized, double-blind, placebo-controlled, phase 3 trial. A total of 28 patients with newly diagnosed T2DM with<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M1"><mml:mrow><mml:msub><mml:mrow><mml:mi mathvariant="normal">H</mml:mi><mml:mi mathvariant="normal">b</mml:mi><mml:mi mathvariant="normal">A</mml:mi></mml:mrow><mml:mrow><mml:mn mathvariant="normal">1</mml:mn><mml:mi mathvariant="normal">c</mml:mi></mml:mrow></mml:msub></mml:mrow></mml:math>levels of 7.5–10.5% were randomly selected to receive dapagliflozin or placebo treatment for 24 weeks. After baseline data were collected, we analyzed glycemic variations and plasma 8-iso PGF 2 α level at baseline and at the endpoint. Primary outcome was the changes of mean amplitude glycemic excursion (MAGE) within groups. Results . After 24-week dapagliflozin therapy, our data showed the significant improvement of MAGE with dapagliflozin therapy (<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M2"><mml:mi>P</mml:mi><mml:mo>=</mml:mo><mml:mn fontstyle="italic">0.010</mml:mn></mml:math>). Compared with control group, patients in dapagliflozin group exhibited reduction in 24-hour MBG (<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M3"><mml:mi>P</mml:mi><mml:mo>=</mml:mo><mml:mn fontstyle="italic">0.026</mml:mn></mml:math>) and lower mean plasma glucose concentrations, especially during periods from 2400 to 0200 and 1300 to 1800 (<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M4"><mml:mi>P</mml:mi><mml:mo>&lt;</mml:mo><mml:mn fontstyle="italic">0.05</mml:mn></mml:math>, resp.). In addition, plasma 8-iso PGF 2 α level was notably decreased in the treatment group compared to the control group (<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M5"><mml:mi>P</mml:mi><mml:mo>=</mml:mo><mml:mn fontstyle="italic">0.034</mml:mn></mml:math>). Conclusions. In conclusion, this study shows the ability of dapagliflozin to improve glycemic variations and associate with reduction of oxidative stress in patients with T2DM, which may benefit the cardiovascular system.