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Clinical Development of a Stable Glucagon Formulation for Bi-hormonal Pump

用于双激素泵的稳定胰高血糖素制剂的临床开发

基本信息

批准号：
8584384
负责人：
Steven Prestrelski
金额：
$ 71.37万
依托单位：
XERIS PHARMACEUTICALS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-08-01 至 2015-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8584384
关键词：
Aging Animals Artificial Pancreas Blood Glucose Blood Tests Body Temperature Cells Clinical Clinical Chemistry Clinical Trials Conduct Clinical Trials Cyclic AMP-Dependent Protein Kinases Development Diabetes Mellitus Dose Drug Formulations Drug Kinetics Family suidae Glucagon Glucose Glycogen High Pressure Liquid Chromatography Hormonal Human Hyperglycemia Hypoglycemia Insulin Insulin Infusion Systems Insulin-Dependent Diabetes Mellitus Life Liquid substance Manufactured Supplies Measures Metric Modeling National Institute of Diabetes and Digestive and Kidney Diseases Octreotide Oryctolagus cuniculus Persons Pharmaceutical Preparations Pharmacodynamics Pharmacology Phase Phase I Clinical Trials Plasma Pre-Clinical Model Preparation Pump Rattus Research Priority Risk Safety Solutions Syringes System Temperature aged aqueous base blood glucose regulation design improved novel preclinical study programs research study response skin irritation stability testing subcutaneous type I diabetic

项目摘要

DESCRIPTION (provided by applicant): The objective of this program is to further the development of a novel, stable, non-aqueous glucagon formulation as an integral component of a bi-hormonal (insulin-glucagon) pump system for treatment of persons with diabetes. The addition of glucagon to the present insulin-based systems will allow greater control of blood glucose with a lower risk of hypoglycemia. The primary objective of the current proposal is directly relevant to an NIDDK research priority, the development of improved delivery systems for the artificial pancreas. This program intends to demonstrate the safety, pharmacokinetics and pharmacodynamics of this novel glucagon formulation in animals and in type 1 diabetics. The major clinical metric for this study will be the capacity of this glucagon formulation to raise glucose levels even after short-term aging in a patch pump chamber. The initial effort of this project will develop and optimize a non-aqueous, liquid glucagon formulation designed for the bi-hormonal pump application, demonstrate its safety, and characterize its pharmacology in preclinical models. The second effort will take the optimized formulation into a clinical supplies manufacturing program. The manufacturing program will produce supplies for the clinical trial in a GMP facility and include shelf-life and 'in-use' stability testing. This effort also includes assessment of the safety, pharmacokinetics and preliminary efficacy (glucodynamics) of the non-aqueous, glucagon solution in a pump system in a Phase 1 clinical trial in type 1 diabetics.

描述（由申请人提供）：该项目的目标是进一步开发一种新型、稳定、非水型胰高血糖素制剂，作为治疗糖尿病患者的双激素（胰岛素-胰高血糖素）泵系统的组成部分。将胰高血糖素添加到现有的以胰岛素为基础的系统中，可以更好地控制血糖，降低低血糖的风险。当前提案的主要目标与NIDDK的研究重点直接相关，即开发改进的人工胰腺输送系统。本项目旨在证明这种新型胰高血糖素配方在动物和1型糖尿病患者中的安全性、药代动力学和药效学。这项研究的主要临床指标将是胰高血糖素配方提高的能力