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25th September,
2009
Phase II Study Results for Capsulin Published in Respected Diabetes Journal
Diabetology Limited announce that results from a positive phase II study on Capsulin oral insulin in patients with type 2 diabetes has been published today in the journal 'Diabetes, Obesity and Metabolism'.
The paper entitled, 'The glucose lowering effect of an oral insulin (Capsulin) during an isoglycaemic clamp study in persons with type 2 diabetes' was authored by Dr. Luzio and colleagues and reports results from a phase II study conducted in 16 patients with type 2 diabetes under the lead of Professor David Owens. This study investigated the safety and efficacy of Capsulin, a capsule dosage form of insulin under development by Diabetology Limited.
In this paper, results have shown that:
- Administration of Capsulin oral insulin to patients with type 2 diabetes demonstrated a significant hypoglycaemic action throughout a 6hr isoglycaemic clamp procedure, and with only a small increase in peripheral circulating plasma insulin.
- During a 10-day repeat-dosing period fluctuations in SMBG were controlled and by the end of the study significant improvements in HbA1c, weight and triglycerides were observed.
- Capsulin had a good safety and tolerability profile throughout the study.
An abstract of the paper and access to copies of it are available at the following website: http://www3.interscience.wiley.com/journal/122609610/abstract
NOTES TO EDITORS
About Diabetology Limited
Diabetology is a specialty biopharmaceutical company
employing a proprietary oral delivery system to administer known
bioactives as well as novel compounds for the comprehensive
management of diabetes.
Diabetology's
lead project is Capsulin, an oral encapsulated formulation of
recombinant human insulin for the treatment of patients with type 1
and type 2 diabetes. Diabetology intends to develop Capsulin both as
a novel oral anti-diabetic agent for the treatment of patients with
type 2 diabetes (Capsulin OAD) and as a replacement to injectable
insulin for patients suffering from type 1 and type 2 diabetes
(Capsulin IR).
The
company’s innovative drug delivery technology, Axcess™ Oral Drug
Delivery System, significantly increases the absorption of peptides,
proteins and other macromolecules across the intestinal wall when
delivered orally without any chemical modification of the active
compounds. It is based on a simple mixture of components
consisting entirely of registered pharmacopoeial or GRAS excipients
with a long history of pharmaceutical use. The absorption enhancing
activities obtained from the formulation of these excipients is
entirely novel and forms the basis of five international patent
applications. Diabetology has licensed exclusive rights to
Axcess™ for the formulation of oral therapies for diabetes.
ENDS
For more information
contact:
Timothy P. Broke-Smith
Corporate Development Officer
Diabetology Limited
Tel: +44 (0)20 7193 8363
Email: t.broke-smith@diabetology.co.uk
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