A 24-week Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HMS5552 add-on to Metformin With Additional 28-week Open-label Treatment to Evaluate the Safety in T2DM Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 767
- 试验地点
- 1
- 主要终点
- Change from baseline in HbA1c
研究概览
简要总结
This study evaluates the efficacy and safety and population PK of HMS5552 add-on to Metformin in adult type 2 diabetic subjects. There will be 2 groups in the first 24 weeks, one group will receive HMS5552 plus Metformin, while the other group will receive placebo plus Metformin; after 24 weeks, all subjects will receive HMS5552 plus Metformin for 28 weeks.
详细描述
This study is a phase III study in subjects with T2DM. As designed, the study will start with a 4-week, single-blind, placebo run-in period based on diet and exercise interventions for screening eligible subjects, meanwhile, subjects are treated with Metformin (Glucophage) at 1500mg/day as basic therapy throughout the treatment period. 3 weeks after run-in, eligibility is confirmed with required laboratory tests at -5±2 days prior to randomization. The eligible subjects are randomly assigned to HMS5552 75mg BID group or placebo BID group with ratio 1:1 to receive a 24-week double-blind treatment. Then all subjects receive 28-week open-label treatment of HMS5552 75mg BID add-on to Metformin. After 52-week treatment, all investigational drugs should be discontinued, followed by 1 week for safety evaluation. The dosage of Metformin (Glucophage) should be maintained at 1500 mg/day from run-in period to treatment completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18~75 years old;
- •T2DM and treated with Metformin ≥ 1500mg/day constantly for at least 12 consecutive weeks;
- •7.5% ≤ HbA1c ≤ 10.0% at screening;
- •18.5 kg/m2 < BMI < 35.0 kg/m2 at screening;
排除标准
- •Any anti-diabetic therapy other than Metformin within 12 weeks before screening;
- •Received insulin therapy more than 30 days within 1 year before screening;
- •Fasting C-peptide <0.81 ng/ml (0.27 nmol/L) at screening;
- •Medical history of severe hypoglycemia or frequent hypoglycemia, diabetic ketoacidosis, diabetes lactic acidosis or hyperosmotic nonketotic diabetic coma, severe cardio-cerebrovascular, unstable or rapidly progressive kidney disease, active liver diseases, diagnosed mental disease etc.
研究组 & 干预措施
Placebo
BID
干预措施: Placebo (Drug)
HMS5552
75mg BID
干预措施: HMS5552 (Drug)
结局指标
主要结局
Change from baseline in HbA1c
时间窗: 24 weeks
The change of HbA1c from baseline by comparing HMS5552 75 mg BID in combination with Metformin with Placebo BID in combination with Metformin in T2DM subjects after 24-week double-blind treatment
次要结局
- Incidence of Treatment-Emergent Adverse Events over time(52 weeks)
- The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline(24 weeks)
- The change of fasting plasma glucose (FPG) from baseline(24 weeks)
- The proportion of subjects with HbA1c < 7.0%(24 weeks)
- The change of HbA1c from baseline at each visit over time, except at Week 24(24 weeks)