A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Empagliflozin (10 mg and 25 mg) Administered Orally Once Daily in Combination With Insulin With or Without up to Two Oral Anti-diabetic Agents for 24 Weeks in Chinese Type 2 Diabetic Patients With Insufficient Glycemic Control.

This is a study in Chinese adults with type 2 diabetes. The study is open to people who take insulin but still have too high blood sugar levels. Participants may additionally be taking up to 2 other medicines for their diabetes. The purpose of this study is to find out whether empagliflozin taken together with insulin helps people with type 2 diabetes to better control their blood sugar. The participants are in the study for about 7 months. During this time, they visit the study site about 8 times, 1 additional visit may be either a visit to the study site or a phone call. At the start of the study, participants are put into 3 groups by chance. Participants get either 10 mg empagliflozin tablets, or 25 mg empagliflozin tablets, or placebo tablets once a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine. The doctors regularly take blood samples from the participants. The changes in blood sugar levels are compared between the groups. The doctors also check the general health of the participants.本研究针对中国成年2型糖尿病（type 2 diabetes）患者开展，纳入正在接受胰岛素治疗但血糖仍控制不佳的受试者。受试者可同时联用至多2种其他糖尿病治疗药物。本研究旨在评估恩格列净（empagliflozin）联合胰岛素方案，能否帮助2型糖尿病患者更有效地控制血糖水平。受试者全程参与研究时长约7个月，期间需前往研究中心完成约8次访视，额外可追加1次访视，该访视可选择亲临研究中心或通过电话完成。研究启动时，受试者将通过随机分组方式被分配至3个组别，每日一次分别服用10mg恩格列净片、25mg恩格列净片或安慰剂（placebo）片。安慰剂片外观与恩格列净片完全一致，但不含任何活性药物成分。研究人员将定期采集受试者血液样本，对比各组受试者的血糖水平变化情况，同时评估受试者的整体健康状况。