Validation of the glucose lowering capability for an innovative fast acting monomeric Insulin

验证创新型速效单体胰岛素的降血糖能力

• 批准号: 710091
• 金额: $ 6.87万
• 依托单位: ARECOR LIMITED
• 依托单位国家: 英国
• 项目类别: GRD Proof of Concept
• 财政年份: 2012
• 资助国家: 英国
• 起止时间: 2012 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=710091
• 关键词: Validation; glucose; lowering; capability; innovative

When a person has diabetes, either their pancreas does not produce the insulin they need (type1 diabetes) or their body does not make enough or cannot make effective use of the insulinthey produce (type 2 diabetes). Two types of insulin are currently marketed, the first is areadily absorbed, rapid onset product intended to supply the bulk level of insulin needed aftera meal; the second type is released slowly and is intended to supply a background level ofinsulin for the day. A long acting insulin has six insulin molecules tightly packed togetherwhereas the rapid insulin is just a single entity, and therefore can act quicker. A recent reportin the British Medical Journal indicated that 80% of Insulin used in the UK is rapid actinginsulin and although it has a superior safety profile, it is up to 5 x more expensive than longacting insulin. Arecor have developed a lab scale manufacturing process whereby long actinginsulin can be converted to the rapid acting form. The approach is simple but has not beendeveloped previously because rapid acting insulin derived from the conventional material isnot stable; it breaks down when stored at high temperatures. Arecor’s proprietary proteinstabilising technology, Arestat®, has been applied to produce a stable rapid acting insulin thatdoes not break down during storage and at high temperatures. Insulin pens that are currentlyused only last a short time before the insulin breaks down. The objective of this study is todemonstrate that the low cost product developed by Arecor has the same glucose loweringkinetics as other rapid acting insulins. With the worldwide diabetic population set to growfrom 285 million to 438 million by 2030, a cost effective insulin product comparable inperformance to the market leading rapid acting insulins will offer substantial savings to theNHS and be competitive in emerging markets.

当一个人患有糖尿病时，要么他们的胰腺不能产生他们需要的胰岛素（1 型糖尿病），要么他们的身体不能制造足够的胰岛素或不能有效利用他们产生的胰岛素（2 型糖尿病）。已上市的第一种是易于吸收、起效迅速的产品，旨在提供餐后所需的大量胰岛素；第二种是缓慢释放的，旨在提供当天的背景水平胰岛素。胰岛素分子紧密地堆积在一起，速度很快胰岛素只是单一实体，因此起效更快。《英国医学杂志》最近的一份报告表明，英国使用的 80% 的胰岛素是速效胰岛素，尽管它具有卓越的安全性，但价格却高出 5 倍。 Arecor 开发了一种实验室规模的生产工艺，可以将长效胰岛素转化为速效形式。该方法很简单，但之前尚未开发出来，因为源自传统材料的速效胰岛素不稳定；存储时下降Arecor 的专有蛋白质稳定技术 Arestat® 已用于生产稳定的速效胰岛素，该胰岛素在储存和高温下不会分解，而目前使用的胰岛素笔在胰岛素分解之前只能持续很短的时间。这项研究的目的是证明 Arecor 开发的低成本产品具有与其他速效胰岛素相同的降血糖动力学，随着全球糖尿病人口预计将从 2.85 亿增长到 4.38 亿。到 2030 年，一种具有成本效益的胰岛素产品，其性能可与市场领先的速效胰岛素相媲美，将为 NHS 节省大量成本，并在新兴市场中具有竞争力。