NCT01398670撤回3 期
Comparison of the Immunogenicity of Wockhardt's Insulin Analogue Lispro and Lispro Mix With Eli Lilly's Insulin Analogue Humalog® and Humalog® Mix in Type 1 Diabetic Patients
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Wockhardt
- 主要终点
- Change in HbA1c
研究概览
简要总结
This is a randomized, parallel group comparison of the immunogenicity safety of Wockhardt's Insulin analogue Lispro and lispro Mix with Eli Lilly's Insulin analogue Humalog® and Humalog® Mix in patients with Type 1 Diabetes Mellitus
详细描述
To evaluate and compare the Immunogenicity safety of Wockhardt's Insulin analogue Lispro and lispro Mix with Eli Lilly's Insulin analogue Humalog® and Humalog® Mix in Type I Diabetic patients.
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 understand the nature of the study and are willing to provide written informed consent.
- •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 body mass index (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.
- •Ability to use the self glucose-monitoring device and to self inject insulin.
排除标准
- •Females who are pregnant or lactating, or not practicing adequate contraception.
- •A Patient with compromised hepatic or renal function
- •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.
- •A Patient who has been treated with other investigational agent or devices within the previous 30 days, has planned use of investigational drugs or devices, or has been previously randomized in this trial.
- •A Patient with history or evidence of allergy to insulin preparations.
- •A Patients who is currently receiving or has received, within the last year, any immunomodulator medications.
- •Patients unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.
- •Patients who are judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned.
结局指标
主要结局
Change in HbA1c
时间窗: 6 months
次要结局
- Percentage change in the immunogenic response(6 months)
- Correlation of the immunogenicity with hypoglycemia(12 months)
研究者
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