Contact: Alisa Cahan 305-672-4422, [email protected]
No More Needles for Insulin Dependent Diabetes Sufferers?
Millions of diabetes sufferers must receive daily insulin injections to avoid serious, often deadly complications. But there's hope: A leading Canadian scientist has developed and patented an oral insulin medication that's now set for human trials with the Health Protection Branch (the Canadian equivalent of the FDA). Next step -- approval in the US.
See Abstract below:
ORALIN & trade; ORAL INSULIN ABSORPTION PROOF OF CONCEPT STUDY IN 7 HEALTHY VOLUNTEERS
Pankaj Modi*1, Jaime Guevara2 Kusiel Perlman3, and Bernard Zinman3. 1Generex Biotechnology Corp., Toronto, Canada, M5J 2G2; 2IEMIR, Quito, Ecuador; 3University of Toronto, Canada.
Purpose.
To provide a proof of concept for oral insulin absorption based upon the suppression of endogenous insulin secretion in normal individuals, as demonstrated by circulating C-peptide levels.
Methods.
The subjects were dosed with placebo (excipients only) on day 1; injected insulin (10 units) on day 2; Oralin™ (100 units) on day 3; Oralin™ (50 units) on day 4; and Oralin™ (160 units) on day 5. Blood samples were drawn every 15 minutes over 3_ hours and were analyzed to confirm the suppression of C-peptide levels.
Results.
The Oralin™ formulation (50) units provided statistically similar (AUC = 3.19) C-peptide lowering results (AUC = 3.62) compared to injected insulin and both were significantly different from the placebo results (AUC = 5.72). The onset of action of oral insulin was faster than the s.c. injected insulin in all cases.
Conclusions.
The suppression in circulating C-peptide levels confirms that Oralin™ (50 units) oral insulin gave similar effect compared to injected insulin (10 units) providing an unequivocal evidence of oral insulin absorption. This unique oral mixed micellar formulation facilitates the absorption of insulin. Thus, it may be possible to deliver other protenic drugs such as HGH, PTH, monoclonal antibodies, vaccines, etc. orally using this formulation. This study was supported by Generex Biotechnology Corporation of Toronto, Canada.
###
RSS