CTRI/2009/091/000912已完成3 期
A 24-week, Randomized, Open-label, Parallel Group Multinational Comparison of Lantus® (Insulin Glargine) Given in the Morning as Once-a-day Basal Insulin Versus NPH Insulin, in Children With Type 1 Diabetes Mellitus Aged at Least 1 Year to Less Than 6 Years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Event rate of "all hypoglycemia" during treatment with study drugs, which consists of: CGM glucose 70 mg/dL (3.9mM) , Self-Monitored Blood Glucose values 70 mg/dL (3.9mM), symptomatic hypoglycemia episodes
研究概览
简要总结
This is a global study being conducted in 19 countries and 100 sites across the globe and 120 is the target size globally. From India, at least 1 patient and max of 3 patients from each of the 5 participating sites are proposed to be enrolled. Therefore, minimum of 5 and maximum of 15 patients will be enrolled from India in total. The Global recruitment is started and so far 7 patients are randimized. 120 patients will be enrolled into the study, in order to have at least 70 evaluable patients completing 24 weeks of treatment. Global date of enrollment, Globally 1st patient was screened on 15/October/2009 and enrolled on 15/Nov/09 in the U.S. We have selected 5 sites in India. We will be recruiting 5-15 patients from India. The anticipated date of enrollment from India will be 25th- June 2010. We have received DCGI approval dated 13 May 2010.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria: Pediatric patients with type 1 diabetes mellitus aged at least one year to less than 6 years, for whom signed written informed consent has been obtained from parent or legal guardian to participate in the study.
排除标准
- •Diagnosis of type 1 diabetes for less than one year HbA1c at screening >12% or <6% Diabetes other than type 1 diabetes.
- •Parents and patients not willing to undergo all study assessments and treatments, including home blood glucose monitoring, Continuous Glucose Monitoring System (CGMS) sensor placement and maintenance both at the site and at home, multiple daily insulin injections, and visits, as dictated by the protocol (if a telephone is not available patients may undergo all visits in person) Patients and families for whom 6 days in total (not necessarily continuous) of useable CGMS data cannot be obtained (either by home sensor replacement, or by sensor replacement at the site at additional screening visits if needed) during the screening CGMS evaluations between Visit 2 and the randomization visit Patients treated with insulin pump therapy during the two months prior to screening History of primary seizure disorder History of severe hypoglycemic episode accompanied by seizure and/or coma, or diabetic ketoacidosis leading to hospitalization or to care in the emergency ward, in the 2 months prior to the screening visit Hypoglycemia unawareness, as determined by the Investigator Serum creatinine > 2.0mg/dL at screening Serum ALT or AST greater than 3x upper limit of normal for the patient's age and gender, at screening Hemoglobin < 10g/dL, or platelet count less than 100,000/cu mm, at screening Treatment with any anti-hyperglycemic oral agent at any time since the diagnosis of diabetes Treatment with any non-insulin antihyperglycemic medication (eg, Symlin®) for the 3 months prior to screening Treatment with systemic glucocorticoids within the month prior to screening.
结局指标
主要结局
Event rate of "all hypoglycemia" during treatment with study drugs, which consists of: CGM glucose 70 mg/dL (3.9mM) , Self-Monitored Blood Glucose values 70 mg/dL (3.9mM), symptomatic hypoglycemia episodes
时间窗: 6 months
次要结局
- vent Rate of Symptomatic Hypoglycemia (Individual Component of Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)(6 months)
研究者
研究点 (4)
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