EUCTR2009-015929-37-IT进行中（未招募）不适用
A PHASE III, MULTINATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE CLINICAL EFFICACY AND SAFETY OF DIAPEP277 IN NEWLY DIAGNOSED TYPE 1 DIABETES SUBJECTS - DIA-AID 2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female subjects between the ages of 20 and 45 years (inclusive) at screening. • A diagnosis of T1D according to the American Diabetes Association and World Health Organization (ADA/WHO) criteria for up to 5 months at screening • A diagnosis of T1D for up to 6 months at randomization (baseline) • Subject has been on insulin since diagnosis of T1D. • Fasting C-peptide levels ? 0.22 nmol/L and <0.8 nmol/L. • Presence of at least 1 of the diabetes-related autoantibodies (IA-2A, GADA, or IAA) • Body mass index (BMI) =17 kg/m2 and < 30 kg/m2 at screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1 The subject has any significant diseases or conditions, including psychiatric disorders and substance abuse that, in the opinion of the Investigator, are likely to affect the subject`s response to treatment or the ability to complete the study. 2 The subject has a history of any kind of malignant tumor. 3 The subject has clinical evidence of any diabetes-related complication that in the opinion of the Investigator would interfere with the subject`s participation in and/or completion of the study.
研究者
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