The gastrin-based therapy, E1-I.N.T.(TM), showed sustained reductions in blood glucose control parameters, including haemoglobinA1C (HbA1c), for 6 months post-treatment. The type 2 diabetes patients enrolled in this study were using metformin with/without thiazolidinediones (TZD).

Chief investigator Doctor Sherwyn Schwartz and CEO Dr. Tony Cruz held a conference call to report the results last Friday.  This is the first time that a drug to control diabetes showed positive results 6 months post treatment.

In the E1-I.N.T.(TM) treated group of patients, the mean HbA1c level was reduced by 0.94% to 1.21% vs. baseline levels in months 2 to 6 post-treatment. More specifically, the mean HbA1c level among treated patients was reduced 0.43%, 0.94% (p(less than)0.05), 1.09% (p(less than)0.05), 1.12% (p(less than)0.05), 1.21% (p(less than)0.05), and 1.14% in months 1, 2, 3, 4, 5, and 6 post-treatment, respectively. In contrast, the mean HbA1c levels of the placebo group ranged from a reduction of 0.1% to an increase of 1.0% over the same period. In addition to the HbA1c reductions, the data demonstrated decreases in fasting blood glucose levels as well as improvements in glucose tolerance over a six month period following treatment with E1-I.N.T.(TM).

Trends in increased insulin levels as measured with an oral glucose tolerance test were also observed, particularly in patients where the HbA1c levels decreased over 1% with E1-I.N.T.(TM) therapy. These data are consistent with the increased glucose control observed in diabetes animal models where a short treatment with E1-I.N.T.(TM) resulted in a sustained increase in beta cell mass and function. These clinical improvements, including HbA1c reductions greater than 1% in patients six month post-treatment, highlight the potential that E1-I.N.T.(TM) therapy could provide patients significant clinical benefit in excess of 6 months.

"These data are very encouraging and show the potential of a regenerative therapy in diabetes," said Sherwyn Schwartz, MD, a noted diabetes researcher and the Director of the Diabetes & Glandular Disease Research Associates in San Antonio, Texas who was the lead investigator of the study. "Achieving sustained improvements in glucose control for many months post-treatment following a 4-week therapy is unprecedented in type 2 diabetes.

The improvements in HbA1c correlated with changes in multiple other clinical parameters suggesting that gastrin-based therapies, and specifically E1-I.N.T.(TM), have the potential to re-engage the body's natural mechanism to regulate glucose," said Dr. Tony Cruz, Chairman and Chief Executive Officer of Transition. "The immediate goal is to optimize the dosing regimen in a larger phase II study".

The results from the Type 1’s also in the study where not reported.

================================

Learn about the ONlY Instant Disposable In Office A1c Test:  Studies have shown that by providing the A1c test in the office while the patient is present, can lower A1c by a full point.  Learn about the only 99% accurate disposable A1c test that is CLIA waived and cost less then 10 dollars and reimbursed at least 21 dollars.    
http://www.a1ctest.com

================================

Help us keep this newsletter free-update your profile
http://www.diabetesincontrol.com/surveys/index.php