Phase IIa in type 1 diabetes positive

The second clinical study of Diabetology's oral insulin product Capsulin™ to investigate the effect of administering two doses of the product in capsules to patients with Type 1 diabetes by measuring blood glucose and circulating plasma insulin levels has been completed. This was a single-centre, open-label, two-way sequential oral dose-finding study using male Type 1 diabetic volunteers.  The two doses investigated were 150iu and 300iu with the volunteers challenged with each dose on one occasion, separated by at least a 120-hour washout period.  The primary endpoint was the absolute change in blood glucose after administration of Capsulin™; the secondary endpoints included its effect on plasma insulin levels. 

During the course of the study, mean blood glucose levels dropped in the subjects; those receiving the higher dose showed a higher fall and blood glucose levels were continuing to fall even at the end of the 7-hour study period.  Insulin levels were detectable above background in the patients’ bloodstream at various times throughout the course of the study.  The main conclusions of the study are as follows:

·         Capsulin appears to be safe & well tolerated in patients with Type 1 diabetes;

·         Capsulin produced consistent increases in blood insulin levels within 30-120 minutes after dosing;

·         Capsulin controlled blood glucose levels for an extended time period after dosing;

·         Both increases in insulin levels and control of glucose levels were dose-dependent.

The study results also supported the hypothesis made as a result of the Phase I study outcome that oral delivery of insulin can help restore hepatic control of the insulin regulation system.

Poster Received well at ADA Meeting, June 2005

Results from the study where presented in the 65th Scientific sessions of the American Diabetes Association congress in San Diego, California.

Click here to see poster (pdf file)