NCT01352663撤回3 期
An Open Label, Randomized Comparison of Wockhardt's Recombinant Insulin Analogue With Innovator's Glargine in Type 1 Diabetic Patients.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Wockhardt
- 主要终点
- Change in HbAlc from baseline till the end of treatment period.
研究概览
简要总结
This is an open label, randomized, parallel group comparison of the immunogenicity safety of Wockhardt's Recombinant Insulin Analogue with the innovator's Glargine in Type 1 diabetics patients.
详细描述
To evaluate and compare the Immunogenicity Safety of Wockhardt's Recombinant Insulin Analogue with innovator's Glargine.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been pre-diagnosed as cases of type-1 diabetes for a period not less than 1 year
- •Male or Female Patients >= 18 and =< 55 years of age.
- •Patients with BMI of 18.0 to 30.0 kg/m2
- •Patients who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures.
排除标准
- •A Patient who is pregnant or is currently breast-feeding.
- •A Patient with history of severe hypoglycemia within the past year
- •A Patient who is an employee of the Investigator, or a patient who has a direct involvement with the trial or other trials under the direction of the Investigator.
- •Patients who are Hepatitis B or C positive on testing or have positive medical history of HIV at screening.
- •Patients unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.
研究组 & 干预措施
Wockhardt's Insulin Analogue (Recomb)
Experimental
Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously.
干预措施: Wockhardt's Insulin Analogue (Recomb) (Biological)
Lantus®
Active Comparator
Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously.
干预措施: Lantus® (Biological)
结局指标
主要结局
Change in HbAlc from baseline till the end of treatment period.
时间窗: 12 months
次要结局
- Percentage change in immunogenic response.(12 months)
研究者
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