News
 

September, 2008

Repeat Dosing Data for Capsulin Phase II in type 2 diabetes presented at the EASD Conference in Rome

 

Diabetology Limited, announced results from the 10-day repeat-dosing of Capsulin™ oral insulin in patients with type 2 diabetes at the European Association for the Study of Diabetes (EASD) meeting in Rome on September 8, 2008.

The study involved 16 patients with type 2 diabetes that received one small capsule of (150IU, 5.6mg) Capsulin™ twice a day during 10 consecutive days.  The results showed that Capsulin™ was able to improve glycaemic control throughout the day, including mealtimes, with reduced glucose fluctuations and postprandial glucose rises.  These observations were associated with significant improvements in HbA1c, weight and triglycerides between pre-study screen and study close.   At the same time Capsulin™ was found to be safe and well tolerated with no serious adverse events and no hypoglycaemia occurring.

During the repeat dosing period self-monitored blood glucose (SMBG) readings that were taken 5-times a day, remained within the recommended range (6-11 mmol/L).  Daily fluctuations in SMBG as assessed by the mean amplitude of glycaemic excursion (MAGE) analysis were reduced over the study period. Analysis of postprandial glucose (PPG) excursions indicated that by day 10 the proportion of post-meal values which fell within a recommended range (<8.9 mmol/L) had increased from 9.7% (day 2) to 35.5% (day 10) (p=0.027).  This effect was more pronounced during the evening meals where the proportion of data points that fell within the recommended range increased from 6.3% (day 2) to 43.8% (day 10) (p=0.009).

These observations were associated with significant improvements in HbA1c (7.38±1.14% to 7.16±0.86%, p<0.05), weight (84.9±11.9 to 84.2±11.6kg, p<0.05) and triglycerides (1.83±0.88 to 1.53±0.60 mmol/l, p<0.05) between pre-study screen and study close. No serious adverse events and no hypoglycaemia were reported.

Prior to study entry, subjects had been on stable doses of oral hypoglycaemic agents (OHA) for at least 3 months and had suboptimal glycaemic control.  During the study, all OHAs apart from metformin were withdrawn (9 out of 16 subjects dropped at least one OHA; 14 remained on metformin; 2 were treated with Capsulin™ alone). Pre-study and post study screening occurred around 5 days prior and post the dosing period respectively.

 

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. [1]
  2. Around 90-95% suffer from type 2 diabetes. [1]
  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] International Diabetes Federation (n.d.) “What is Diabetes?”. Available from: http://www.idf.org/home/index.cfm?node=2 [Accessed 24 August, 2008]

ENDS

For more information contact:

Dr Roger New
Chief Scientific Officer
Diabetology Limited

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

Timothy P. Broke-Smith
Corporate Development Officer
Diabetology Limited

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