EUCTR2009-015929-37-FI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
- •1The 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.
- •2The subject has a history of any kind of malignant tumor (not including basal cell skin cancer).
- •3The 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.
- •4Subject has history of endogenous allergic reactivity:
- •a.Severe allergic reaction or severe exacerbation of allergic asthma within 12 months prior to the Screening Visit.
- •b.Ongoing systemic asthma treatment.
- •c.Subjects with history of life-threatening or severe allergy, re-occurrence of which cannot be ruled out based on the Investigator’s judgment.
- •d.The subject has known allergy to lipid emulsions.
- •5The subject has a known immune deficiency from any disease, or a condition associated with an immune deficiency.
- •6The subject is receiving immunosuppressive or immunomodulating agents or cytotoxic therapy or any medication for more than 4 weeks that in the opinion of the Investigator might interfere with the study.
- •7The subject has any of the following clinically significant laboratory abnormalities:
- •a.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of the normal (ULN) at the Screening Visit.
- •b.Total bilirubin greater than 2 times the ULN at the Screening Visit.
- •c.Subjects with severe renal failure at the screening visit (as defined by glomerular filtration rate < 30 mL/min/1.73 m2 by Cockroft Gault calculation (Cockcroft and Gault, 1976)).
- •d.Clinically significant laboratory abnormalities, confirmed by repeat measurement, which may interfere with the assessment of safety and/or efficacy of the study drug, other than hyperglycemia and glycosuria at the Screening Visit.
- •e.Fasting triglycerides >1000 mg/dL (11.3 mmol/L) at the Screening Visit. Suitable medical therapy for treatment of hyperlipidemia is allowed.
- •8The subject is a known or suspected drug abuser.
- •9The subject is known to test positive for HIV antibodies.
- •10The subject has chronic hematologic disease.
- •11The subject has liver disease such as cirrhosis or chronic active hepatitis.
- •12The subject has received any investigational drug or participated in another clinical study for the indication of prevention or treatment of diabetes, at any point in the past.
- •13The subject has received any investigational drug, not diabetes-related, within 1 month prior to the Baseline Visit (Visit 1).
- •14The subject has already been treated with DiaPep277®.
- •15The subject has had a severe blood loss (= 400 mL, e.g., blood donation) within 2 months before the first dose of the study medication.
- •16The subject receives a forbidden medication
研究者
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