2015年6月5日，勃林格殷格翰-礼来糖尿病联盟合作研发的2型糖尿病复方新药Synjardy（empagliflozin/盐酸二甲双胍）获欧盟委员会（EC）批准，用于2型糖尿病（T2D）成人患者的治疗。Synjardy每日口服2次，该药有4种剂量规格（empagliflozin/二甲双胍）：5mg/850mg，5mg/1000mg，12.5mg/850mg，12.5mg/1000mg。Synjardy不适用于1型糖尿病患者，也不适用于伴有糖尿病酮症酸中毒（血液或尿液中酮体升高）的患者。
Synjardy是由empagliflozin（恩格列净）和盐酸二甲双胍组成的复方单片，具有2种独特的降血糖机制。empagliflozin已于2014年获欧盟批准，商品名为Jardiance，该药属于新兴的钠-葡萄糖协同转运蛋白-2（SGLT-2）抑制剂类药物，而盐酸二甲双胍则是一种常见的2型糖尿病治疗药物。SGLT-2抑制剂已被证实能够阻断肾脏中葡萄糖的再吸收作用，将过多的葡萄糖排泄到体外，从而达到降低血糖水平的效果，而且该降糖效果不依赖于β细胞功能和胰岛素抵抗。
Synjardy适应症为结合运动及饮食，用于改善2型糖尿病成人患者的血糖控制。
具体而言，欧盟委员会已批准Synjardy用于：
（1）最大耐受剂量二甲双胍单药治疗时仍不能充分控制血糖水平的2型糖尿病患者；
（2）二甲双胍联合其他降糖药（包括胰岛素）仍不能充分控制血糖水平的2型糖尿病患者；
（3）正在接受empagliflozin和二甲双胍联合治疗的2型糖尿病患者。
Synjardy的获批，是基于7个III期临床试验的强劲临床数据，这些试验调查了empagliflozin联合二甲双胍单药治疗或与其他降糖药（吡格列酮、磺脲类、DPP-4抑制剂、胰岛素）联合治疗时的疗效和安全性。数据显示，当配合使用或不使用其他降糖药时，与二甲双胍单药治疗相比，empagliflozin（10mg和25mg）与二甲双胍联合治疗使血糖、体重、血液实现临床意义的显著下降。临床试验中，Synjardy联合胰岛素和/或磺脲类药物时最常见的副作用为低血糖。
Synjardy(empagliflozin/metformin hydrochloride)
Empagliflozin/metformin HCl will be made available in the following twice-daily doses in the EU:
5mg empagliflozin plus 850mg or 1000mg metformin HCl
12.5mg empagliflozin plus 850mg or 1000mg metformin HCl
Synjardy® combines two products with different mechanisms of action to improve glycaemic control in patients with T2D
Side effects identified with Synjardy® are consistent with known safety profiles of the individual compounds
US, 28 May, 2015 - Synjardy® has been granted marketing authorisation by the European Commission for the treatment of adults with type 2 diabetes (T2D) in the European Union (EU). Synjardy® is a new single-pill combination therapy from the Boehringer Ingelheim and Eli Lilly and Company diabetes alliance.
Synjardy® combines empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, and metformin hydrochloride (HCl), commonly prescribed for the treatment of T2D. Empagliflozin was approved in the EU in May 2014 and is available in many countries as an oral, once-daily tablet, marketed
as Jardiance®.1
Synjardy® is indicated for use alongside diet and exercise to improve blood glucose control in adults with T2D when they are:2
Inadequately controlled on their maximally tolerated dose of metformin alone
Inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin
Already being treated with the combination of empagliflozin and metformin as separate tablets
"A single medicine is often not sufficient for patients to maintain blood glucose control in the long term, resulting in the need for combinations of blood glucose-lowering drugs," said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. "We are delighted to offer this single-pill combination of two agents with different mechanisms. Synjardy® may help adults with T2D achieve their blood glucose targets with the added benefit of a convenient treatment regimen."
The marketing authorisation follows the positive opinion from the Committee for
About the Phase III Clinical Trials2
The marketing authorisation is based on the submission of robust clinical data from seven Phase III clinical trials evaluating the safety and efficacy of empagliflozin as add-on to metformin either alone or in combination with other blood glucose-lowering drugs (pioglitazone, sulphonylurea, DPP-4 inhibitors and insulin). More than 7,000 patients with T2D participated, of which over 4,700 were treated with empagliflozin as add-on to metformin.
The results showed that treatment with empagliflozin (10mg and 25mg) when added to metformin, with or without other blood glucose-lowering drugs, led to clinically relevant reductions in blood glucose, body weight and blood pressure compared to placebo as add-on to metformin.
The most common side effect reported by patients in the clinical trials was hypoglycaemia (low blood glucose) when empagliflozin and metformin were used in combination with insulin and/or sulphonylurea. In general, the adverse event profile of empagliflozin as add on to metformin was consistent with the known safety profile of the individual compounds empagliflozin and metformin.
The common side effects experienced with empagliflozin are urinary tract and genital infections, increased urination and itching. The common side effects experienced with metformin are gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite as well as taste disturbance.
About empagliflozin/metformin hydrochloride (HCl)2
Empagliflozin/metformin HCl should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. For further information on contraindications, warnings and precautions for use please refer to the summary of product characteristics.