A Multi-center, Randomized, Open-label, Parallel-group, Phase Ⅲ Study to Evaluate the Efficacy and Safety of Insulin Aspart Injection in Patients With Diabetes Mellitus Compared to NovoRapid®
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 563
- 试验地点
- 2
- 主要终点
- The change of relative baseline HbA1c
研究概览
简要总结
This is a multicenter, randomized, open, parallel group, active-controlled study. The study period is 25 to 26 weeks, including screening period of 1-2 weeks and treatment period of 24 weeks.
详细描述
After the screening visit, all patients who met all inclusion criteria and do not meet any of the exclusion criteria were randomized into the experimental group or the controlled group. The subjects in the experimental arm will receive insulin aspart injection combined with basal insulin (Lantus ®), and the subjects in the controlled arm will receive NovoRapid ® (active control) combined with basal insulin (Lantus ®). The experimental drug or the controlled drug will be administered subcutaneously prior to three meals (or can be administered immediately after meal if necessary), and the basal insulin (Lantus ®) will be administered at bedtime. The treatment period is 24 weeks, during which the subjects will be followed up at the clincic cetres at 1, 2, 4, 8, 12, 18, 24 weeks of treatment. At the end of 24-week treatment, if the adverse events continue, the subjects will be followed until recovery or stabilization of the AEs.
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
- None
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
- •Patients were diagnosed with diabetes;
- •BMI≤35.0 kg/m2;
- •Insulin therapy for at least 3 months before recruitment;
- •HbA1c7~13%
排除标准
- •Patients to study drug allergy;
- •to Liver and kidney impairment;
- •Liver and kidney impairment;
- •used systemic steroid treatment in past 2 months .
结局指标
主要结局
The change of relative baseline HbA1c
时间窗: 24 weeks
次要结局
未报告次要终点
