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 During the study, all OHAs apart from metformin were withdrawn (9 out of 16 subjects dropped at least one OHA; 14 remained on metformin; 2 were treated with Capsulin™ alone).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:
- 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
About the results from the recent phase II
- Phase II study in 16 patients with type
2 diabetes involving glucose clamp procedures
and 10 days repeat dosing.
- Indication of improved blood glucose control
after 10 days of dosing:
- Significant reductions in HbA1c, weight
and triglycerides. These are parameters
that are strong indicators of glucose
- No safety concerns.
- Good tolerability.
- In the glucose clamp procedures:
- Delivery of insulin by Capsulin™
was confirmed by a clear glucose response.
- In contrast to injected insulin, Capsulin™
produced a glucose response without
levels of insulin rising substantially
in the outer-circulation.
- Glucose response observed was of extended
- Duration of response was consistent
with a product that may be administered
- Comparable variability to subcutaneous
injected insulin was also noted.
- Capsulin™ oral insulin has successfully
led to desired changes in glucose metabolism.
 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