FDA在2015年以临床试验数据不足为由拒绝了阿斯利康推出的Qtern治疗Ⅱ型糖尿病，近日却大开绿灯。

　　研究发现，在固定剂量组合的DPP-4抑制剂saxagliptin和SGLT-2抑制剂dapagliflozin的双重作用下能够降低血糖。

　　对于成人Ⅱ型糖尿病使用dapagliflozin 或 dapagliflozin 和 saxagliptin联合.治疗的病人来说应当以日常饮食作为辅助来降低血糖水平。

　　Ⅱ型糖尿病作为一个复杂的疾病，已经开始成为一个普遍性疾病，在美国有2900百万人得此病。Qtern的批准使得患者能够每日通过 DPP-4 抑制剂 和 SGLT-2 抑制剂每日简便的改善血液里的血糖含量。

　　研究人员用了24周的实验数据来使得FDA通过此药物用于临床。此药物常见的不良反应是低血糖和上呼吸道感染。

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　　The fixed-dose combination of the DPP-4 inhibitor saxagliptin and SGLT-2 inhibitor dapagliflozin offers a dual approach to lowering blood glucose levels.

　　The treatment is indicated as an adjunct to diet and exercise to improve glycaemic (blood sugar level) control in adults with type II diabetes who have inadequate control with dapagliflozin or who are already treated with dapagliflozin and saxagliptin.

　　"Type II diabetes is a complex disease that is at epidemic proportions, affecting more than 29 million people in the US alone. The approval of Qtern is good news for patients who may benefit from improved glycaemic control by adding a DPP-4 inhibitor to a SGLT-2 inhibitor in a convenient once-daily tablet," said Elisabeth Bj?rk, vice president, head of Cardiovascular and Metabolic Diseases, Global Medicines Development at AZ.

　　The approval was based on data from a 24-week, Phase III, multi-centre, randomised, double-blind, placebo-controlled trial (n=315) designed to evaluate the efficacy and safety of saxagliptin added to dapagliflozin in adult patients with type II diabetes who experienced inadequate glycaemic control with metformin.

　　In one study where saxagliptin 5mg or placebo was added to patients treated with dapagliflozin 10mg and metformin, mean changes from baseline HbA1c were -0.51 percent and -0.16 percent respectively at 24 weeks.

　　Also, the proportion of patients achieving a HbA1c of less than 7 percent at week 24 was higher in the saxagliptin plus dapagliflozin plus metformin group (35.3 percent) compared to the placebo plus dapagliflozin plus metformin group (23.1 percent).

　　On the safety side, the pill's side effects were comparable to that of saxagliptin and dapagliflozin, AZ noted, the most frequently reported adverse reactions being hypoglycaemia (when used with a SU) and upper respiratory tract infection.