TRIAL TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS OF GLUCAGON IN TYPE I

评估 I 型胰高血糖素的安全性、耐受性和药代动力学的试验

• 批准号: 7376316
• 负责人: VIVIAN A FONSECA
• 金额: $ 0.64万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376316
• 关键词: TRIAL; ASSESS; SAFETY; TOLERABILITY; PHARMACOKINETICS

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The first proof of principle pilot study entitled :A Phase 1, Multicenter, Open Label, Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Very Low Dose Glucagon (VLD Glucagon) in Subjects with Type 1 Diabetes Mellitus" will validate the prophylactic use of VLD glucagon in Type 1 diabetes to prevent or blunt insulin-induced hypoglycemia. The objectives of the study are to evaluate the pharmacokinetics and pharmacodynamics and the safety and tolerability of VLD glucagon administered as a continuous subcutaneous infusion in subjects with type 1 diabetes mellitus treated with continous subcutaneous infusion of insulin (CSII) The study will enroll up to 25 subjects, who have type 1 deabetes mellitus for > 10 years and who are well controlled on a stable regimen of CSII therapy. Each eligible subject will have a series of 5 GCRC visits, each consisting of 1-day (overnight) admission. A study evaluation period will be terminated immediately in the event of blood glucose less than or equal to 50mg/dL or greater than or equal to 250 mg.dL. After overnight fasting and while on their usual basal insulin infusion each subject will receive an infusion of either vehicle or VDL glucagon based on a protocol specific algorihm via a second subcutaneous pump from 7 AM until 1 PM. Glycemic control to the study drug will be monitored by frequent blood glucose (every 5-15 min). Visits 1-3 will determine the concentration of glucagon that doesn't cause hyperglycemia. In study visits 4 and 5, the subject usual basal infusion rate of insulin will be doubled to induce hypoglycemia. At visit 4, the second pump will infuse vehicle and at visit 5 the concentration of VLD glucagon will be infused that did not cause hyperglycemia in visits 2 or 3. The objective of the study visit 5 is to blunt or prevent insulin induced hypoglycemia without causing hyperglycemia.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中得到体现。列出的机构是中心的机构，不一定是研究者的机构。第一项原则性试点研究的证明题为：评估极低剂量胰高血糖素 (VLD 胰高血糖素) 在 1 型糖尿病受试者中的安全性、耐受性、药代动力学和药效学的 1 期、多中心、开放标签临床试验”，将验证 VLD 胰高血糖素在 1 型糖尿病中的预防性使用，以预防或减弱胰岛素诱发 低血糖。该研究的目的是评估连续皮下注射胰岛素 (CSII) 治疗的 1 型糖尿病受试者的药代动力学和药效学以及 VLD 胰高血糖素的安全性和耐受性。该研究将招募最多 25 名患有 1 型糖尿病的受试者，用于治疗 1 型糖尿病。 > 10 年并且通过稳定的 CSII 治疗方案得到良好控制。每个符合条件的受试者将进行一系列 5 次 GCRC 访问，每次包括 1 天（过夜）入场。如果血糖低于或等于50mg/dL或高于或等于250mg.dL，研究评估期将立即终止。每位受试者禁食过夜并进行常规基础胰岛素输注后 将从上午 7 点到下午 1 点根据方案特定算法通过第二个皮下泵输注媒介物或 VDL 胰高血糖素。将通过频繁的血糖（每 5-15 分钟）监测研究药物的血糖控制。第 1-3 次访视将确定不会引起高血糖的胰高血糖素浓度。在研究访问 4 和 5 中，受试者通常的胰岛素基础输注率为 加倍可诱发低血糖。在第 4 次访视时，第二个泵将输注媒介物，在第 5 次访视时，将输注不会在第 2 次或第 3 次访视中引起高血糖的 VLD 胰高血糖素浓度。第 5 次访视研究的目的是减弱或预防胰岛素引起的低血糖，而不引起高血糖。