Successful Phase I Study in Healthy Volunteers

The first clinical study of Diabetology's oral insulin product Capsulin™ has been successfully completed in the UK (Royal Surrey County Hospital) investigating the effect of administering two doses of the product in capsules to healthy volunteers. Patients were given either 170iu or 340iu Capsulin™ and monitored for up to three hours (glucose, insulin and C-peptide).

The main conclusions of the study are as follows:

• The study has successfully proven oral insulin delivery by Capsulin™. Insulin was absorbed in a physiological form as evidenced by changes in C-peptide;
• A non-linear relationship between doses suggests the 170iu dose may be >90% bound by the liver insulin receptors before and overspill of insulin into the circulation, and that 340iu floods the liver & has large spill over into plasma (10 times the plasma level with 170iu).

Poster Presented at ADA 2004

DIABETOLOGY PRESENTS POSITIVE PHASE I HUMAN DATA FROM ORAL INSULIN DEVELOPMENT PROGRAM AT AMERICAN DIABETES ASSOCIATION CONGRESS IN ORLANDO JUNE 5th-7th 2004 

 "Diabetology Ltd, the British based company developing an oral form of Insulin for Diabetics, announced today that a scientific abstract based on the first successful human tests carried out with its Capsulin™ form of Oral Insulin has been accepted for presentation at the 64th Scientific sessions of the American Diabetes Association congress in Orlando, Florida in June.

Mr Glen Travers, Diabetology’s co-founder added “We have achieved a great milestone in proving our technology can deliver Insulin orally, and we look forward to pushing forward with our clinical development of Capsulin™ in Diabetics over the coming months.

Currently diabetics who need insulin must inject themselves daily, and it has been an aim of doctors for a long time to find a better way to deliver insulin."

In 2004 Diabetology's lead project the development of oral Insulin is completing its phase I development, and is anticipated to move into phase II, in June-July 2004, ethics approval for a study to test the treatment Type 1 Diabetics has been received.

Diabetology continues to fund the project internally at present but is in talks with potential partners to allow acceleration of the clinical development program over the coming months.

Click here to see poster (pdf file)