Type 1 Diabetes TrialNet: Toronto Clinical Centre

1 型糖尿病 TrialNet：多伦多临床中心

基本信息

批准号：
8468928
负责人：
DIANE K WHERRETT
金额：
$ 27.25万
依托单位：
HOSPITAL FOR SICK CHLDRN (TORONTO)
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-30 至 2015-06-30
项目状态：
已结题

项目摘要

DESCRIPTION (provided by applicant): The first objective of this application is describe the strengths and successes of the TrialNet Clinical Center at the Hospital for Sick Children/University of Toronto. The Toronto Clinical Center has shown a high level of recruitment for the TrialNet Natural History of the Development of Type 1 Diabetes Study through its highly capable investigators, Drs. Diane Wherrett and Jeffrey Mahon, providing expertise in diabetes, clinical trials and immunology of type 1 diabetes, its excellent coordinators, institutional support and resources, a productive Canadian affiliate network and extensive local partnerships in the Toronto area. Recruitment to this study ranks 4th of the 14 North American TrialNet Clinical Centers. This center has provided leadership in TrialNet studies: Dr. Mahon, chair of the Natural History Study of the Development of Type 1 Diabetes Study and Dr. Wherrett, chair of the Effects of Recombinant Human Glutamic Acid Decarboxylase (rhGAD65) Formulated in Alum (GAD-alum) on the Progression of Type 1 Diabetes in New Onset Subjects Study. It has contributed actively to all of TrialNet's studies to preserve insulin secretion in recent onset diabetes. The second objective is to determine the efficacy and safety of the incretin mimetic exenatide (Byetta(), alone and in combination with the anti-CD20 monoclonal antibody rituximab (Rituxan(), in patients with newly recognized immune-mediated Type 1 Diabetes. The proposal's primary objective will be to test the hypothesis that the combination of exenatide and rituxamab more effectively preserves endogenous insulin secretion compared to either drug alone. The primary outcome will be the area under the stimulated C-peptide curve (AUC) during a 2 hour mixed meal glucose tolerance test one year after study entry. The study will be placebo controlled and double blinded. The rationale for this proposed study combines the immunomodulatory effect of rituximab to reduce beta cell autoimmunity with the beta cell regenerative potential of exenatide to improve insulin secretion. Preserved endogenous insulin secretion has been found to be associated with reduced of rates of the diabetes complications of hypoglycemia, nephropathy and retinopathy.

描述（由申请人提供）：本申请的第一个目标是描述多伦多病儿童/大学医院试验网临床中心的优势和成功。多伦多临床中心通过其强大的研究人员DRS DRS显示了1型糖尿病研究的试验网络自然史的招募水平。 Diane Wherrett和Jeffrey Mahon，在1型糖尿病的糖尿病，临床试验和免疫学方面提供专业知识，其出色的协调员，机构支持和资源，加拿大富有生产力的加拿大分支机构网络以及多伦多地区的广泛当地伙伴关系。这项研究的招募是北美试验网临床中心中的第四名。该中心在试验网研究中提供了领导才能：Mahon博士是1型糖尿病开发研究的主席，而Wherrett博士是重组人谷氨酸脱羧酶（RHGAD65）在校友（GAD-ALUM）中对1型糖尿病型在新妇女研究中的1型糖尿病进展的影响的主席。它为所有试验网的所有研究都积极做出了贡献，以在最近的糖尿病中保留胰岛素分泌。第二个目标是确定泌尿素模拟腺苷的功效和安全性（BYETTA（BYETTA（BYETTA（），并与抗CD20的单克隆抗体利妥昔单抗（Rituxan（）（Rituxan（）），在新认识的免疫介导的1型糖尿病的患者中，提案的原始目标将效果更高。与任何两种药物相比，内源性胰岛素分泌是在研究后2小时的混合饮食葡萄糖耐受性测试的刺激曲线（AUC）的区域。已发现伴晶纳化物可改善胰岛素分泌。