Oral GLP-1 Study Presented at the EASD Conference in Rome
Results from a preclinical study on Axcess™ oral formulated GLP-1 analogues have been presented in a poster presentation during the European Association for the Study of Diabetes (EASD) meeting in Rome, September 7-11, 2008.
This proof of concept study has confirmed that, using a standard pharmaceutical capsule, the Axcess delivery technology is capable of delivering oral encapsulated GLP-1 analogues via the jejunum. This supports the development of Axcess-formulated GLP-1 and/or its analogues or mimetics as an oral alternative to the subcutaneous injections of these peptides for the treatment of type 2 diabetes in man.
The pharmacodynamics of encapsulated analogues of GLP-1 (G001 and G002) using proprietary Axcess™ oral formulations were investigated in relation to subcutaneous injected delivery of the same GLP-1 analogues in juvenile domestic pigs. The Axcess formulation has already been tried and tested in humans and proved successful in phase II studies with insulin (previously presented at ADA).
Six study arms used 5-8 juvenile domestic pigs each. The dosing groups were: placebo capsule (Axcess excipients only), no treatment, 0.4 mg s.c. injected G001, 0.4 mg s.c. injected G002, 4 mg capsule Axcess-formulated G001, 4 mg capsule Axcess-formulated G002. The Axcess-formulated capsules where delivered via intrajejunal stoma. Treatments took place on days 1, 3, 7, 9, 11, 14, 16 and 18. Blood samples were taken at t+0, 10, 15, 30, 60, 120, 180, 240, 300, 360 and 480 minutes. As this was the first test of these peptides in this model and using this oral delivery formulation, doses used were comparatively large in order to ensure that there were data generated for analysis.
Falls in blood glucose were observed for all treatment arms which were greater than the controls. The oral formulations of each analogue generated glucose falls that were similar to those produced by the s.c. injection treatments. No advantage was gained by incorporating a protease inhibitor in the formulation.
NOTES TO EDITORS
About Diabetology Limited:
- Diabetology Limited is an international
biopharmaceutical research and development
company based in Jersey, UK. Please visit:
- Capsulin™ utilizes novel Axcess™
oral deliver technology that incorporates
absorption enhancers with unmodified bioactives
in a convenient encapsulated form.
- Axcess™ was developed by Dr Roger
New and has already been shown to deliver
three peptides in man safely and effectively.
- Diabetology Limited was established by
Dr Roger New and Glen Travers in 2002 and
is a subsidiary of Proxima Concepts Limited.
- More than 245 million people worldwide
are afflicted by diabetes, this is expected
to rise to 380 million within 20 years.
- Around 90-95% suffer from type 2 diabetes.
- Diabetes is a metabolic disorder that
leads to elevated blood sugar levels that
are damaging to your health.
- Poorly controlled diabetes can cause complications
such as blindness, heart disease, stroke,
kidney failure, amputations, coma and premature
- The incidence of diabetes is increasing
on an epidemic scale, causing major clinical
and financial challenges to healthcare systems
- Type 1 diabetes is treated with insulin,
and by maintenance of a regulated diet.
Insulin is typically delivered through injections
at regular intervals throughout the day,
which can be uncomfortable and inconvenient.
Currently there is no oral insulin treatment
available on the market.
- For many, type 2 diabetes can be controlled
with diet alone, but medication is used
when diet does not provide adequate control.
Although oral anti-diabetic treatments are
available for sufferers of type 2, the efficacy
of such drugs is limited and none of these
work by delivering insulin, the natural
blood glucose controlling hormone, to the
 International Diabetes Federation (n.d.)
“What is Diabetes?”. Available
[Accessed 24 August, 2008]
For more information contact:
Dr Roger New
Chief Scientific Officer
Tel: +44 (0)781 806 8012
Timothy P. Broke-Smith
Corporate Development Officer
Tel: +44 (0)20 7193 8363