Journal of Chinese Pharmaceutical Sciences ›› 2016, Vol. 25 ›› Issue (2): 128-139.DOI: 10.5246/jcps.2016.02.014

• 【Original articles】 • Previous Articles     Next Articles

Efficacy and safety of saxagliptin in patients with type 2 diabetes mellitus: a meta-analysis of randomized controlled trials

Li Yao, Fangfang Fan, Lan Hu*, Shengjun Zhao, Lili Zheng   

  1. Department of Clinical Pharmacy, Hospital of Chinese Medicine Affiliated to Xinjiang Medical University, Urumqi 830000, China
  • Received:2015-08-28 Revised:2015-10-18 Online:2016-02-29 Published:2015-10-28
  • Contact: Tel.: 86-991-5887716, E-mail:
  • Supported by:
    Xinjiang Medical University Scientific Research and Innovation Foundation (Grant No. XYDCX2014117).


As a new oral hypoglycemic agent, saxagliptin belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors. However, it remains inconclusive whether saxagliptin is associated with increased risk of adverse events (AE) and efficacy as add-on treatment. Therefore, we performed an up-to-date meta-analysis to compare the efficacy and safety of saxagliptin with placebo and other oral hypoglycemic agents in adult patients with type 2 diabetes mellitus (T2DM). Randomized clinical trials (RCTs) comparing saxagliptin with comparators were retrieved by selecting articles from Pubmed, Embase, Cochrane Library and Clinical Trials Registry Platform up to Oct. 2013. Weighted mean difference (WMD) was used to analyze the effect of hypoglycemic agents on HbA1c, weight and fasting plasma glucose (FPG). While the patients who achieved HbA1c<7.0% and had AE were analyzed as relative risks (RR).A total of 18 articles from 16 RCTs and one clinic trial from the WHO International Clinical Trials Registry Platform met the included criterion. Clinically significant decrease from baseline HbA1c compared with placebo was certified for 2.5 mg/day saxagliptin (WMD = –0.45%, 95%CI, –0.48% to –0.42%) and 5 mg/d saxagliptin (WMD = –0.52%, 95%CI, –0.60% to –0.44%). Saxagliptin as add-on therapy was superior to thiazolidinediones, up-titrated glyburide, up-titrated metformin or metformin monotherapy in achieving HbA1c<7.0%. Treatment with saxagliptin had negligible effect on weight, and it was considered weight neutral. Saxagliptin treatment did not increase the risk of hypoglycemia (RR = 1.28, 95% CI 0.72 to 2.27, P = 0.40) and serious adverse experiences (RR = 1.25, 95% CI 0.94 to 1.66, P = 0.13). No statistically significant differences were observed between saxagliptin and comparators in terms of the risk of infections.The present study showed that saxagliptinwas effective in improving glycaemic control in T2DM with a low risk of hypoglycaemia and incidence of infections in either monotherapy or add-on treatment. This founding should be further certified by large-sample size and good-designed RCT.

Key words: DPP-4 inhibitor, Saxagliptin, Meta-analysis, Type 2 diabetes mellitus, Fasting plasma glucose, Glycosylated hemoglobin, Randomized controlled trial, Hypoglycaemia

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