The era of oral insulin is upon us

The discovery of insulin 100 years ago revolutionized the world of incurable diabetes.
However, the existing insulin administration methods are all injection administration, which have deficiencies such as hypoglycemia, weight gain and poor compliance, thus restricting the use of many patients.
Because of this, in the past century, scholars at home and abroad have never stopped the pursuit of non-injectable insulin.
In the oral administration, buccal mucosa, sublingual, nasal cavity, inhalation, skin and other ways of drug delivery have been explored, but the road of exploration is rather bumpy, the previous research and development ended in failure.

On May 15, 2021, the 9th China Diabetes, Obesity and Hypertension Conference from Debate to Consensus (CODHYAP) was held. At this conference, oral insulin capsule (ORMD-0801) subverted the tradition and broke through many technical difficulties and made new progress, which attracted the attention of experts and scholars attending the conference.

Wang Weiqing, director of the Department of Endocrinology at Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, said at the conference:
“Oral insulin capsule because of its unique formula and function mechanism, after intestinal positioning absorption, directly by the portal vein to the liver, consistent with human insulin physiological way, to avoid the high peripheral blood insulin hematic disease, thereby reducing the side effects such as weight gain, hypoglycemia, and patients with oral medicine is convenient for taking and storage, avoid injections bring discomfort to the patient,
It also better mimics the physiological insulin pathway, which greatly improves patient treatment convenience and compliance.”

Ning Guang, President of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine and Academician of Chinese Academy of Engineering, said, “Oral insulin capsule simulates the physiological pathway of insulin secretion in the human body. It can be absorbed through the intestinal tract and directly into the liver, which is more in line with the physiological state.
Its appearance can help patients to start insulin treatment as early as possible and improve patients’ compliance, so as to better control blood glucose fluctuations and delay the occurrence and progression of complications. It is of great help to improve the quality of life of patients with diabetes and has a positive impact on the treatment strategy of diabetes.
We sincerely hope that oral insulin can be marketed as soon as possible to benefit hundreds of millions of diabetic patients around the world.”

So, can oral insulin replace insulin injection?
Professor Cheng Zhifeng, director of endocrinology at the Fourth Affiliated Hospital of Harbin Medical University, said that according to the current research and development progress, the efficacy of different oral insulin candidates is different due to the differences in bioavailability caused by the differences in research and development strategies and structures.
We believe that the use of oral insulin can partially replace the injection of insulin. On the one hand, some patients with poor effects of oral hypoglycemic drugs and who are still unwilling to use insulin as recommended by doctors can use oral insulin.
On the other hand, patients with relatively small doses of insulin injection (specifically according to the results of clinical studies) can switch to oral insulin, which can also meet the requirements of glucose control, and “partially replace insulin injection” can be achieved from the above two aspects.

Professor Isamar Raz, Chairman of the National Diabetes Committee of Israel, said, “For over 100 years, insulin has been administered by injection in clinical practice around the world, and long-term and frequent subcutaneous injections have brought both physical and mental pain to patients.
Under the leadership of Academician Ning Guang and Director Wang Weiqing of Ruijin Hospital, oral insulin capsule Ⅲ phase III clinical study has been carried out in 36 hospitals in China, and clinical trials are also being carried out in the United States and Europe, which is the world’s first and largest oral insulin phase III clinical study.
We look forward to making oral insulin available soon to benefit more people with type 2 diabetes.”

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