A Randomized, Active Controlled, Parallel Group, Multicentre, Two-Phase, Open-Label Study Comparing the Safety and Immunogenicity of Insugen R and Insugen N with Actrapid and Insulatard in Patients with Type 1 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biocon SA
- 入组人数
- 286
- 试验地点
- 7
- 主要终点
- Change in immunogenicity between Insugen R plus Insugen N and Actrapid plus Insulatard groups
研究概览
简要总结
This Study is a A Randomized, Active Controlled, Parallel Group, Multi-Center, Two Stage, Open Label, Study Comparing Safety and Immunogenicity of Insugen® R and Insugen® N with Actrapid® and Insulatard® in Patients with Type 1 Diabetes Mellitus for approximately 48 weeks in 286 patients that is conducted in India (8 sites), Germany (2 sites), Hungary (7 sites), Italy (4 sites), Romania (9 Sites), Ukraine (8 Sites),56 patients will be enrolled in India, 230 patients from Ukraine & EU. Primary outcome is to compare the change in mean anti Insulin antibody binding percentage from Baseline to week 24 for comparitive phase and from baseline to week 48 for non - comparative phase . Secondary outcome is to compare the Safety, Immunogenicity & efficacy of Insugen R plus Insugen N versus EU sourced Actrapid plus Insulatard.INC research is the CRO to conduct the trial. Date of first Enrollment will be around July end/August 2010. The Status of the whole trial is: Not yet recruiting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Provide written informed consent
- •Patients between the ages of 18 to 80 years
- •T1DM patients diagnosed with in the last 1 year.
- •Patients on basal-bolus insulin therapy
- •Body mass index of 18.5 to 34.99 kg/m2
- •Stable weight
- •Glycosylated haemoglobin of less than or equal to 11.0 percentage
- •Ability and willingness to comply with the protocol.
排除标准
- •1.History of hypersensitivity to any of the active or inactive ingredients of the test and/or reference products 2.Significant history of atopy or allergic drug reactions 3.Use of insulin pump therapy 4.Moderate insulin resistance 5.A clinically significant laboratory abnormality on the basis of which the Investigator advises against study inclusion 6.Clinically significant disease, except for well-controlled hypertension, hyperlipidaemia and thyroid disorders which as per the investigator makes the patient unsafe to be included in the study 7.Complications of abnormal glucose control and secondary complications of diabetes 8.An electrocardiogram abnormality considered clinically significant by the Investigator 9.History of drug or alcohol dependence or abuse within 6 months before Screening 10.Use of medications that can affect sugar control 11.Any electively planned surgery requiring hospitalization 12.Pregnancy, breastfeeding, or planned pregnancy during the study duration.
- •Women of childbearing potential (any woman who is not surgically sterile or more than 2 years post menopause) must agree to use a reliable method of contraception (e.g., double-barrier, tubal ligation, or stable hormonal contraception) throughout the study period.
- •Women who become pregnant during the study must be discontinued from the study and followed for pregnancy outcome 13.Hematological disorders 14.Receipt of another investigational drug within 6 weeks before Screening or within 5 half-lives of the drug, whichever is longer, or scheduled treatment of another investigational drug during the current study period.
结局指标
主要结局
Change in immunogenicity between Insugen R plus Insugen N and Actrapid plus Insulatard groups
时间窗: From baseline to Week 24 and 48
次要结局
- Safety parameters including Local and systemic reactions, hypoglycaemic events per 100 patients and other AE’s(Between baseline, week 24 and 48)
- Diabetes Treatment Satisfaction Questionnaire(Between baseline and week 24)
- Partial correlation between allergic reactions and insulin antibodies, HbA1c and insulin antibodies, insulin dose and insulin antibodies(Between baseline and week 24)
- Efficacy parameters including HbA1c, FPG, 7-PCBG and insulin dose(Between baseline and week 24)