Efficacy and safety of saxagliptin in newly diagnosed type 2 diabetes mellitus patients

Xiu Shuangling; Wang Li

doi:10.3760/cma.j.issn.1673-4777.2015.03.018

Abstract：Objective To assess the efficacy and safety of saxagliptin in newly diagnosed type 2 diabetes mellitus patients.Methods The sixty newly diagnosed type 2 diabetes mellitus patients were randomly and equally divided into the saxagliptin group and the placebo group,which were administrated with saxagliptin and placebo for 16 weeks,respectively.The fasting plasma glucose (FBG),two-hour postprandial plasma glucose (2 hPG),hemoglobin A1c (HbA1c),body mass index (BMI),homeostatic model assessment of insulin resistance index (HOMA-IR),the targeting rate of HbA1c,the incidence of adverse reactions and hypoglycemia for both groups were observed.Results The levels of FBG,2 hPG,HbA1c and HOMA-IR were significantly decreased in saxagliptin group after 16 weeks of treatment (P ＜ 0.05) [FBG:(7.5 ± 0.8) mmol/L vs (9.1 ± 1.2) mmol/L,P ＜ 0.01 ; 2 h PG:(8.0 ±0.9)mmol/L vs (13.1 ±0.8)mmol/L,P＜0.01; HbA1c:(6.8 ±0.9)％ vs (8.5 ±0.5)％,P＜ 0.01 and HOMA-IR:(2.8 ± 0.8) vs (3.3 ± 0.5),P ＜ 0.05].Compared to the placebo group,the levels for FBG,2 hPG,HbA1c,HOMA-IR for saxagliptin group reduced more obviously [FBG:(7.5 ± 0.8)mmol/L vs (8.5 ± 0.9)mmol/L,P＜0.05; 2 hPG:(8.0±0.9)mmol/Lvs (12.5±1.4)mmol/L.P＜0.01; HbA1c:(6.8± 0.9)％ vs (7.9 ±0.8)％,P＜0.05; and HOMA-IR:(2.8 ±0.8) vs (3.2 ±0.5),P ＜0.05].There were no significant differences for BMI between the two groups,pre.and post.treatment The targeting rate in the saxagliptin group was higher than the placebo group [83.3％ (25/30) vs 26.7％ (8/30)] (P ＜ 0.01).In addition,hypoglycemia did not occur in either groups.Conclusions Saxagliptin can effectively decrease the blood glucose,reduce insulin resistence and control weight of newly diagnosed type 2 diabetes mellitus patients without increasing the risk of hypoglycemia.