在新诊断的1型糖尿病中,特普利祖马布和β细胞功能
Eleanor L Ramos1, Colin M Dayan1, Lucienne Chatenoud1
1From Provention Bio, a Sanofi company, Red Bank, NJ (E.L.R., L.A.K., W.T.); Cardiff University, Cardiff, United Kingdom (C.M.D.); Université Paris Cité, CNRS, INSERM, Institut Necker Enfants Malades-INEM, Paris (L.C.); the Department of Pediatrics, Motol University Hospital, Second Faculty of Medicine-Charles University, Prague, Czech Republic (Z.S.); the Barbara Davis Center for Diabetes/University of Colorado School of Medicine, Aurora (K.M.S.); the Medical University of Warsaw, Warsaw, Poland (A.S.); the University of California, San Francisco, San Francisco (S.E.G.); Sanofi, Frankfurt, Germany (E.N.); and the Departments of Immunobiology and Internal Medicine, Yale University, New Haven, CT (K.C.H.).
在新诊断为1型糖尿病的儿童和青少年中,Teplizumab治疗显示改善了β细胞功能保护. 然而,二次临床终点在特普利祖马布和安慰剂组之间没有显著差异.
科学领域:
- 免疫学 免疫学 免疫学
- 内分泌学 在内分泌学.
- 临床试验 临床试验
背景情况:
- 德普利祖马布是一种FDA批准的单克隆抗体,用于在临床前阶段延迟1型糖尿病的临床发展.
- 它在新诊断的1型糖尿病中预防疾病进展的有效性尚未确定.
研究的目的:
- 评估静脉注射特普利祖马布对新诊断为1型糖尿病的儿童和青少年的β细胞保存的影响.
- 评估与特普利祖马布治疗相关的临床终点和安全概况.
主要方法:
- 一个3期,随机的,安慰剂对照试验,涉及两种12天的teplizumab或安慰剂疗程.
- 主要终点:在78周刺激的C-水平的变化.
- 二级终点:胰岛素剂量,糖化血红蛋白,葡萄糖范围中的时间和低血糖事件.
主要成果:
- 与安慰剂相比,Teplizumab治疗导致78周刺激C-水平显著提高.
- 一个较高的百分比的Teplizumab治疗的患者保持了临床上有意义的峰值C-水平.
- 两组之间在关键的二次临床终点上没有发现显著差异.
结论:
- 两次特普利祖马布疗程显示,在新诊断的1型糖尿病患者中,在维护β细胞功能方面有好处.
- 对于二次临床终点没有发现显著差异,这表明需要进一步研究.
相关概念视频
Dipeptidyl Peptidase 4 Inhibitors
Glucagon-like Receptor Agonists
GLP-1, when administered in high doses intravenously, triggers insulin secretion, inhibits glucagon release, slows gastric emptying, reduces food intake, and restores normal insulin secretion. However, its rapid inactivation by...
Diabetes Mellitus: Overview and Type I Subtype
Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks and destroys the insulin-producing beta cells in the pancreas. As a result, the body is unable to produce sufficient insulin, and individuals with...
Diabetes Mellitus: Type 2 and Gestational
Diabetes: Management and Pharmacotherapy
Insulin remains the cornerstone of treatment for most patients with type 1 and many...
Insulin: Dosing Regimen and Adverse Effects
The basal dose constitutes about 40%-50% of the total daily dose, with the rest as premeal insulin. The mealtime insulin dose should mirror...


