R&D, Biocon Limited, Bangalore, Karnataka, India.
Diabetes Obes Metab. 2010 Mar;12(3):179-85. doi: 10.1111/j.1463-1326.2009.01150.x.
Oral insulin is one of the most exciting areas of development in the treatment of diabetes because of its potential benefit in patient convenience, rapid insulinization of liver, adequate insulin delivery avoiding peripheral hyperinsulinaemia while potentially avoiding adverse effects of weight gain and hypoglycaemia. Growing evidence that earlier initiation of intensive insulin therapy produces sustained tight glycaemic control resulting in substantial delay in complications makes an effective oral insulin product even more vital for the management of patients with diabetes. Despite knowledge of this unmet medical need, oral delivery of insulin has been unsuccessful because of several barriers. For several decades, researchers have tried to develop oral insulin using various technologies without much clinical or commercial success. This review summarizes the development status of oral insulins which are publicly reported to be undergoing clinical studies. Currently, two oral insulin products are in an advanced stage of clinical development and first data from long-term therapy are expected to be available in the second half of 2010.
口服胰岛素是糖尿病治疗中最令人兴奋的领域之一，因为它有可能使患者更方便，快速地使肝脏胰岛素化，在避免外周高胰岛素血症的同时提供充足的胰岛素，而潜在地避免体重增加和低血糖的不良反应。越来越多的证据表明，早期开始强化胰岛素治疗可产生持续的严格血糖控制，从而大大延迟并发症的发生，因此对于糖尿病患者的管理，有效的口服胰岛素产品变得更加重要。尽管人们认识到这一未满足的医疗需求，但由于存在多种障碍，口服胰岛素的递送一直未能成功。几十年来，研究人员一直在尝试使用各种技术开发口服胰岛素，但临床和商业上都没有取得多大成功。这篇综述总结了正在进行临床研究的公开报道的口服胰岛素的开发状况。目前，有两种口服胰岛素产品处于临床开发的后期阶段，预计 2010 年下半年将获得长期治疗的首批数据。
