News
 

25th June, 2007

Positive Reaction to Diabetes Pill Breakthrough at ADA Conference in Chicago

The news announced on Friday, at the American Diabetes Association (ADA) annual scientific conference in Chicago, that an oral insulin capsule could be available for diabetes sufferers has received positive interest worldwide.

Attendees at the 67th annual scientific meeting of the ADA, including world-renowned medical and scientific diabetes specialists, were presented positive results from a recent phase II study of Diabetology Ltd’s Capsulin™, oral insulin, conducted in 16 type 2 diabetes patients. Results from this study have shown that insulin delivered in a single small capsule had the desired effect on blood glucose metabolism. After 10 days dosing, with patients maintaining their normal diet and lifestyle, significant positive changes were observed. These results suggest that two capsules of Capsulin™ per day could be an effective way of improving the management of the disease in this patient group.

Positive reactions have been posted by charitable organisations working for people with diabetes, including the Juvenile Diabetes Research Foundation:-

Sarah Johnson, Director of Policy and Communications, Juvenile Diabetes Research Foundation, commented: “This research shows promising early results and we are pleased that there are indications that this oral medication may one day be suitable for people with type 1 diabetes, all of whom are currently dependent on multiple daily insulin injections to stay alive. We will continue to watch this research with great interest.”

In addition, reactions from the international press have been equally supportive:-

Nigel Hawkes, Health Editor of the Times described the finding as a “Breakthrough by Cardiff researchers” and stated in his review article on the results that the “disease may be better controlled”. [1]

Daniel Bates of the Daily Mail, commented how: “it [Capsulin™] will be eagerly awaited by the nation’s 2.35 million diabetes sufferers, many of whom are forced to give themselves several injections a day to control the condition.” [2]

Other news sources that have covered the story include the BBC. [3]

Dr Anthony Lockett, Medical Director of Diabetology Ltd, explained the importance of the new oral treatment: “This is a promising development in the drive towards producing an oral insulin that could improve the management of diabetes considerably. As an oral anti-diabetic, Capsulin™ may present an opportunity to treat those with type 2 diabetes earlier in their disease progression, potentially delaying disease development. In addition, as a replacement to painful injections, it could herald improved compliance, convenience and better blood glucose control. Due to its special method of delivery and route of uptake of insulin, Capsulin™ allows the passage of the insulin administered to mimic normal physiology – delivering it to the liver, and avoiding other organs such as adipose tissue and muscle. This is important for reducing the risk of hypoglycaemic events and complications of diabetes due to artificially high levels of outer-circulating insulin in the bloodstream, as occurs when insulin is injected.”

Dr Roger New, Chief Scientist and co-founder of Diabetology Ltd, said: “We have now developed a preparation of insulin that can be ingested orally and absorbed to have a measurable effect on plasma glucose concentrations. The treatment will undergo further clinical testing and offers new hope to sufferers.”

Capsulin™ is a potential new oral treatment for sufferers of both type 1 and type 2 diabetes that can deliver effective insulin via a capsule. This solution to therapy, using a substance naturally produced by the body, could ultimately reduce the need for injections for patients with diabetes. Diabetology’s candidate offers a convenient, oral dosage form, particularly benefiting those with needle phobia or people who have severe trouble injecting.

In addition, Capsulin™ potentially has an important advantage over other forms of insulin delivery as it closely mimics the insulin secretion pathway used by the pancreas to deliver insulin to the liver. The promise of Capsulin™ is to restore the balance of outer-circulating levels of insulin to a more normal, physiological level thereby potentially avoiding serious side effects.

In support of this, the recent phase II study has shown evidence of improved blood sugar control without the need for higher outer-circulating levels of insulin. In the study, which was led by Professor David Owens, Director of the Diabetes Research Unit at Cardiff University, Capsulin™ treatment was examined in people with type 2 diabetes for the first time. Results suggest that Capsulin™ can exert a marked effect on glucose output from the liver, while minimizing the level of undesirable insulin appearing in the bloodstream.

These results extend outcomes of a successful phase II study for Capsulin™ carried out at Bradford Teaching Hospital in type 1 diabetes in 2005 [4]. As Capsulin™ treatment has now been shown to have an effect in both type 1 and type 2 diabetes, the results could offer new hope of more effective treatment for around 245 million diabetes sufferers worldwide [5].

 

NOTES TO EDITORS

About Diabetology Limited:

  1. Diabetology Limited is an international biopharmaceutical research and development company based in Jersey, UK. Please visit: http://www.diabetology.co.uk .
  2. Capsulin™ utilizes novel Axcess™ oral deliver technology that incorporates absorption enhancers with unmodified bioactives in a convenient encapsulated form.
  3. Axcess™ was developed by Dr Roger New and has already been shown to deliver three peptides in man safely and effectively.
  4. Diabetology Limited was established by Dr Roger New and Glen Travers in 2002 and is a subsidiary of Proxima Concepts Limited.

About diabetes:

  1. More than 245 million people worldwide are afflicted by diabetes, this is expected to rise to 380 million within 20 years. [5]
  2. Around 90-95% suffer from type 2 diabetes. [5]
  3. Diabetes is a metabolic disorder that leads to elevated blood sugar levels that are damaging to your health.
  4. Poorly controlled diabetes can cause complications such as blindness, heart disease, stroke, kidney failure, amputations, coma and premature death.
  5. The incidence of diabetes is increasing on an epidemic scale, causing major clinical and financial challenges to healthcare systems globally
  6. 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.
  7. 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 liver.

About the results from the recent phase II study:

  1. Phase II study in 16 patients with type 2 diabetes involving glucose clamp procedures and 10 days repeat dosing.
  2. Indication of improved blood glucose control after 10 days of dosing:
    1. Significant reductions in HbA1c, weight and triglycerides. These are parameters that are strong indicators of glucose control.
    2. No safety concerns.
    3. Good tolerability.
  3. In the glucose clamp procedures:
    1. Delivery of insulin by Capsulin™ was confirmed by a clear glucose response.
    2. In contrast to injected insulin, Capsulin™ produced a glucose response without levels of insulin rising substantially in the outer-circulation.
    3. Glucose response observed was of extended duration.
    4. Duration of response was consistent with a product that may be administered twice daily.
  4. Comparable variability to subcutaneous injected insulin was also noted.
  5. Capsulin™ oral insulin has successfully led to desired changes in glucose metabolism.

References:

[1] Hawkes, N. (2007) “Insulin pill promises an end to the needle for diabetics”. The Times (London). Available from: http://www.timesonline.co.uk/tol/life_and_style/health/article1969239.ece . [Accessed: 23 June, 2007]

[2] Bates, D. (2007) “The insulin pill that could mean no more injections for diabetics”, Daily Mail (London). Available from: http://www.dailymail.co.uk/pages/live/articles/health/healthmain.html?in_article_id=463688&in_page_id=1774 . [Accessed: 23 June, 2007]

[3] BBC Online (2007) “'Insulin pill' hope for diabetes”. Available from: http://news.bbc.co.uk/1/hi/health/6229398.stm . [Accessed: 23 June, 2007]

[4] Diabetology Limited (2005). Available from: http://www.diabetology.co.uk/ph2a_release_191005.htm . [Accessed 23 June, 2007]

[5] International Diabetes Federation (n.d.) “What is Diabetes?”. Available from: http://www.idf.org/home/index.cfm?node=2 [Accessed 24 June, 2007]

ENDS

For more information contact:

Dr Roger New
Chief Scientific Officer
Diabetology Ltd

Tel: +44 (0)781 806 8012
Email: rn@diabetology.co.uk

Timothy P. Broke-Smith
Senior Analyst
Diabetology Limited

Tel: +44 (0)20 7193 8363
Email: t.broke-smith@diabetology.co.uk